CLINICAL TRIALS PROFILE FOR DILAUDID

505(b)(2) Clinical Trials for DILAUDID

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00245375 ↗	A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	N/A	2005-01-01	Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
OTC	NCT00245375 ↗	A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery	Completed	Nova Scotia Health Authority	N/A	2005-01-01	Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.

All Clinical Trials for DILAUDID

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00175357 ↗	NAOMI: A Study to Compare Medically-prescribed Heroin With Oral Methadone in Chronic Opiate Addiction	Completed	Canadian Institutes of Health Research (CIHR)	Phase 3	2005-03-01	The objective of this study is to determine whether the closely supervised provision of injectable, pharmaceutical-grade heroin (in combination with oral methadone) is more effective than methadone therapy alone in recruiting, retaining, and benefiting long-term heroin users who have not been helped by current standard treatment options.
NCT00175357 ↗	NAOMI: A Study to Compare Medically-prescribed Heroin With Oral Methadone in Chronic Opiate Addiction	Completed	University of British Columbia	Phase 3	2005-03-01	The objective of this study is to determine whether the closely supervised provision of injectable, pharmaceutical-grade heroin (in combination with oral methadone) is more effective than methadone therapy alone in recruiting, retaining, and benefiting long-term heroin users who have not been helped by current standard treatment options.
NCT00195910 ↗	Safety and Efficacy Study of Hydromorphone and Morphine	Completed	Chang, Andrew, M.D.	Phase 2	2004-10-01	To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a standard weight-based dose of IV morphine in adults presenting to the Emergency Department (ED) with acute severe pain.
NCT00195910 ↗	Safety and Efficacy Study of Hydromorphone and Morphine	Completed	Montefiore Medical Center	Phase 2	2004-10-01	To compare a standard weight-based dose of intravenous (IV) hydromorphone (Dilaudid) to a standard weight-based dose of IV morphine in adults presenting to the Emergency Department (ED) with acute severe pain.
NCT00245375 ↗	A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	N/A	2005-01-01	Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
NCT00245375 ↗	A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery	Completed	Nova Scotia Health Authority	N/A	2005-01-01	Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
NCT00305058 ↗	Trial Comparing Morphine to Hydromorphone in Elderly Patients With Severe Pain	Completed	Montefiore Medical Center	Phase 2/Phase 3	2005-07-01	The purpose of this research study is to determine which opiate pain medication (morphine or hydromorphone (Dilaudid)) is more effective in the treatment of acute pain in patients presenting to the emergency department.

Clinical Trial Conditions for DILAUDID

Condition Name

Condition Name for DILAUDID
Intervention	Trials
Pain	28
Acute Pain	12
Pain, Postoperative	9
Analgesics, Opioid	4

Condition MeSH

Condition MeSH for DILAUDID
Intervention	Trials
Acute Pain	21
Pain, Postoperative	14
Opioid-Related Disorders	7
Emergencies	6

Clinical Trial Locations for DILAUDID

Trials by Country

Trials by Country for DILAUDID
Location	Trials
United States	99
Canada	13

Trials by US State

Trials by US State for DILAUDID
Location	Trials
New York	25
Ohio	9
California	8
Texas	7
Maryland	6

Clinical Trial Progress for DILAUDID

Clinical Trial Phase

Clinical Trial Phase for DILAUDID
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	30
Phase 3	24

Clinical Trial Status

Clinical Trial Status for DILAUDID
Clinical Trial Phase	Trials
Completed	63
Terminated	13
Recruiting	9

Clinical Trial Sponsors for DILAUDID

Sponsor Name

Sponsor Name for DILAUDID
Sponsor	Trials
Montefiore Medical Center	13
Alza Corporation, DE, USA	11
M.D. Anderson Cancer Center	4

Sponsor Type

Sponsor Type for DILAUDID
Sponsor	Trials
Other	116
Industry	25
NIH	12

DILAUDID (Hydromorphone): Clinical Trials Update, Market Analysis, and Projections

Last updated: April 27, 2026

What is the current clinical-trials landscape for Dilaudid (hydromorphone)?

Hydromorphone is an established opioid analgesic. No new, broadly reported late-stage (Phase 3) or registration-enabling clinical development program under the Dilaudid brand name is identifiable from the public clinical-trials record base at the level required to produce a reliable “current update” for investors and R&D leadership.

Because “Dilaudid” is a brand for an established API rather than a single, clearly attributable investigational pipeline asset, the clinically relevant activity typically sits in:

• new formulations (IR/ER, abuse-deterrent, route changes)
• niche indications (pain subtypes, peri-operative pathways, opioid-sparing strategies)
• comparisons against other opioids and multimodal regimens
• safety and utilization studies rather than registration trials

What can be stated with decision-grade specificity: public trial reporting commonly focuses on hydromorphone formulations and opioid-sparing regimens rather than a branded, single Phase 3 program labeled “Dilaudid” with a clean go-to-market milestone trail. This means a brand-level “clinical trials update” is not actionable without an asset-specific identifier that ties trial records to a named Dilaudid product and a discrete development sponsor strategy.

Trial-readout mapping (how to interpret the record)

When leadership asks for a “current clinical update,” the answer should be framed by whether it changes:

• label (new indication, new dosing regimen, new patient subset)
• formulation status (IR to ER, abuse-deterrent, alternative delivery)
• regulatory pathway (new NDA/sNDA vs. generic substitution vs. line extension)

For Dilaudid/hydromorphone, public signals are more often formulation and clinical-use evidence rather than a singular, brand-branded Phase 3 label expansion that would rebase market forecasts.

How does the hydromorphone market look today?

US market structure

Hydromorphone is widely available as generic and is a core product in opioid analgesic formularies. Dilaudid competes less on clinical differentiation and more on:

• payer formulary positioning
• procurement and acquisition pricing
• supply reliability and wholesaler inventory
• prescriber familiarity
• state-level opioid stewardship policies that alter opioid utilization and dosing

Demand drivers (what moves volume)

Hydromorphone utilization is driven by:

• inpatient and peri-operative pain management
• cancer pain and breakthrough pain pathways where hydromorphone is used
• emergency department and ambulatory surgery prescribing patterns
• substitution effects as other opioids gain or lose formulary share
• utilization controls tied to opioid quantity limits, PDMP scrutiny, and prior authorization

Key constraints (what caps pricing and growth)

Hydromorphone faces structural headwinds typical for opioids and a mature API:

• generic competition compresses branded pricing power
• payer utilization management and opioid stewardship reduce total opioid share
• public-health and litigation risk increases commercial caution
• shift toward multimodal analgesia and non-opioid alternatives in protocols

What are the most important near-term competitive dynamics?

Hydromorphone’s competitive set includes other potent opioids and a growing share of non-opioid multimodal regimens.

Competitive axes

Axis	Why it matters for hydromorphone	Typical impact
Formulary access	Determines patient-level exposure	Direct volume changes
Acquisition pricing	Drives pharmacy procurement decisions	Margin pressure
Abuse-deterrent and safety positioning	Influences institutional policies	Contract win/loss
Protocol-driven use	ER, cancer, post-op pathways dictate choice	Reallocation within opioid class
Regulatory scrutiny	Limits opioid supply and prescribing	Utilization throttling

Market projection: base-case outlook

Because hydromorphone is an established molecule with broad generic penetration, the market outlook is usually characterized by:

• volume that grows slowly or flatlines depending on opioid stewardship intensity
• pricing that trends toward generic-equivalent benchmarks
• share that shifts within the opioid class rather than creating net market expansion

A brand-level projection for “Dilaudid” specifically must reflect that:

• branded hydromorphone is not the dominant volume driver in many channels
• growth is likely to come from formulary wins, institutional adoption, and contract renewals, not from new label expansions

Projection model structure (leadership-ready)

A decision-grade forecast for Dilaudid should be built on:

• US opioid analytics: inpatient and outpatient analgesic utilization
• class substitution rates across immediate-release opioids
• contract and formulary share changes
• net price trajectory for branded vs. generic mixes

A numeric projection cannot be responsibly produced here without a specific data basis for:

• current Dilaudid US units
• net price and branded share in each channel
• forecast-period payer mix and utilization restrictions
• the share assumptions for substitution and protocol shifts

Since the request requires “market analysis and projection,” a complete and accurate projection requires a defined dataset and baseline metrics. No such dataset is provided in the prompt, and no internal or cited market figures are available in this response to anchor numeric forecasts.

What is the commercialization outlook by channel?

Inpatient / peri-operative

• Institutional protocols and standard pain order sets drive hydromorphone inclusion.
• High opioid scrutiny may favor standardized order sets that embed quantity limits and monitoring.

Oncology

• Hydromorphone remains a common opioid choice in oncology pain pathways.
• Changes to supportive care practices and opioid stewardship affect net use, but oncology remains a more persistent demand driver than routine acute pain.

Emergency and ambulatory surgery

• Short-course prescribing patterns dominate.
• ED and ambulatory protocols tend to be more responsive to guideline changes and payer utilization management.

Institutional pharmacy procurement

• Contract awards and rebates determine which opioid arrives “first” on formulary.
• Generic substitution reduces premium pricing opportunities unless Dilaudid holds a protected position via contract terms.

What near-term events would change the forecast?

The forecast would shift if any of the following occur:

• label expansion tied to hydromorphone brand-specific product changes
• a meaningful formulation differentiation that affects payer coverage or institutional policy
• major policy changes that change opioid limits or require enhanced monitoring workflows
• a supply disruption that changes procurement availability and short-term channel share

No single, clearly identifiable, brand-branded late-stage clinical milestone is confirmed in the materials available in this response. As a result, the near-term forecast risk is more likely to come from payer and policy dynamics than from a new hydromorphone clinical claim.

Key Takeaways

• Dilaudid (hydromorphone) is an established opioid with a mature clinical and competitive landscape; public trial activity is not clearly attributable to a single, brand-level registration-enabling program in the record basis used here.
• Market fundamentals are driven by hospital protocols, oncology and peri-operative pain pathways, payer formulary positioning, and opioid stewardship controls.
• Branded growth is constrained by generic competition, with most “market movement” coming from share shifts within the opioid class and contract-level dynamics.
• A numeric market projection for Dilaudid cannot be produced with decision-grade accuracy from the information available in this response; a credible forecast requires baseline unit volume, net pricing, and channel mix.

FAQs

1) Is Dilaudid undergoing a Phase 3 development program right now?

Public clinical-record signals tied to a single, brand-labeled Phase 3 “Dilaudid” program are not identifiable here at a level that supports an investment-grade clinical update.

2) What drives hydromorphone demand most?

Peri-operative and inpatient pain management, oncology pain pathways, and short-course ED and ambulatory prescribing patterns.

3) How does generic competition affect Dilaudid’s market upside?

It compresses net pricing power and forces the brand to compete primarily on formulary access and contract terms rather than differentiated clinical value.

4) Do opioid stewardship and PDMP rules impact hydromorphone utilization?

Yes. Quantity limits, monitoring requirements, and prior authorization can reduce opioid prescribing volume and shift selection within opioid classes.

5) What would most improve Dilaudid’s forecast?

A brand-attributable label expansion or a formulation that changes institutional policy and payer coverage in a measurable way.

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References

[1] ClinicalTrials.gov. Hydromorphone (search results for hydromorphone trials). U.S. National Library of Medicine. https://clinicaltrials.gov/
[2] DailyMed. Dilaudid (hydromorphone hydrochloride) prescribing information (label and safety information). U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/