CLINICAL TRIALS PROFILE FOR DILAUDID-HP

505(b)(2) Clinical Trials for DILAUDID-HP

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-HP

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.

Clinical Trial Conditions for DILAUDID-HP

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for DILAUDID-HP

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for DILAUDID-HP

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for DILAUDID-HP

Sponsor Name

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

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Dilaudid-HP

Last updated: October 28, 2025

Introduction

Dilaudid-HP, a combination formulation comprising hydromorphone hydrochloride—a potent opioid analgesic—and acetaminophen, is utilized primarily for managing moderate to severe pain. Its clinical significance, regulatory landscape, and market dynamics merit detailed analysis, especially amid rising concerns about opioid usage and the demand for effective pain management solutions.

This comprehensive review offers an update on the latest clinical trials involving Dilaudid-HP, provides a nuanced market analysis, and projects future growth trajectories, equipping industry stakeholders with strategic insights.

Clinical Trials Update for Dilaudid-HP

Recent Clinical Research Developments

While Dilaudid-HP has been historically approved for specific pain conditions, recent clinical research has focused on optimizing its efficacy and safety profile across diverse patient populations. Key recent initiatives include:

• Analgesic Efficacy Studies: Trials assessing its effectiveness in postoperative pain management have demonstrated significant pain relief, with a well-characterized safety profile, consistent with prior data (e.g., [1]).

• Comparative Effectiveness Trials: Multiple studies compare Dilaudid-HP to other opioid formulations. Data indicate comparable or superior analgesic efficacy with acceptable tolerability, emphasizing its role in multimodal pain regimens (e.g., [2]).

• Safety and Tolerance Studies: Recent investigations explore the potential for dependency, overdose risks, and optimal dosing strategies. Notably, research emphasizes the importance of monitoring usage to mitigate opioid misuse risks ([3]).

• Formulation Innovations and Delivery Methods: Clinical trials are examining novel delivery methods designed to reduce abuse potential, including abuse-deterrent formulations, which are critical amid regulatory shifts ([4]).

Regulatory and Approval Status

The FDA continues to regulate Dilaudid-HP strictly due to its opioid classification. While no new approvals for Dilaudid-HP have been issued recently, ongoing trials aim to enhance formulation safety features, support label updates, or expand indications—especially for chronic pain conditions—pending favorable outcomes.

Ongoing and Future Clinical Trials

Currently, there are no actively recruiting high-impact trials specifically involving Dilaudid-HP registered on ClinicalTrials.gov. However, forthcoming studies may include:

• Long-term safety assessments in chronic pain populations.

• Comparative studies evaluating abuse-deterrent formulations versus traditional Dilaudid-HP.

• Population-specific efficacy trials among elderly and comorbid patients.

This landscape suggests a cautious but persistent pursuit of optimizing Dilaudid-HP’s clinical utility within regulatory and safety frameworks.

Market Analysis of Dilaudid-HP

Global Market Overview

The global opioid analgesics market was valued at approximately USD 10.4 billion in 2021 and is projected to reach USD 16.2 billion by 2028, growing at a CAGR of about 7.5% ([5]). Dilaudid-HP, as a recognized brand of hydromorphone equivalents, occupies a notable segment, especially in differentiated pain management protocols.

Market Drivers

• Rising Incidence of Chronic Pain: The prevalence of conditions like cancer, post-surgical pain, and osteoarthritis drives demand for potent analgesics, including Dilaudid-HP.

• Advancements in Formulation & Safety Features: Development of abuse-deterrent formulations (ADFs) responds to regulatory pressures and public safety concerns, expanding market access.

• Growing Aging Population: Elderly patients with complex pain profiles require effective opioid options, bolstering Dilaudid-HP's market presence.

• Regulatory and Reimbursement Trends: Favorable insurance and regulatory pathways for specific indications enhance accessibility, although stringent controls temper overuse.

Market Challenges

• Opioid Crisis and Regulatory Environment: The global opioid epidemic has led to intensified regulations, prescription monitoring programs, and increased scrutiny, constraining growth potential ([6]).

• Alternatives and Non-Opioid Therapies: The advent of non-opioid analgesics and interventional techniques may curtail opioid consumption.

• Market Competition: Generic formulations and new abuse-deterrent products from competitors intensify price competition and market fragmentation.

Regional Market Dynamics

• North America: Dominates due to high opioid prescription rates, though declining amidst regulatory crackdowns. The U.S. represents the largest share, with a shift toward clinical caution.

• Europe: Growth is tempered by conservative prescribing habits but is expected to expand with increasing acceptance of effective formulations and pain interventions.

• Asia-Pacific: Rapid growth fueled by increasing healthcare infrastructure, pain prevalence, and evolving regulatory frameworks.

Market Share and Competitive Landscape

Major pharmaceutical companies, such as Purdue Pharma (now under bankruptcy-related restructuring), Teva Pharmaceuticals, and Sun Pharma, produce Dilaudid-HP or equivalent formulations. Market differentiation lies in formulation innovations, abuse-deterrent properties, and regulatory compliance.

Forecast and Future Trends

• The opioid analgesics market's compound annual growth rate (CAGR) is expected to remain steady at approximately 7.0-8.0%, influenced by emerging regulatory constraints and evolving treatment paradigms.

• Dilaudid-HP's share within this market trajectory is likely to stabilize or subtly decline, unless innovation-driven differentiation or expanded indications occur.

• The development of non-opioid combination therapies and targeted delivery systems could further influence Dilaudid-HP's market position over the next decade.

Strategic Market Projection

Considering current clinical and regulatory trends, Dilaudid-HP is positioned for moderate growth, primarily driven by:

• Incremental adoption in settings emphasizing potent analgesics with safety features.

• Expansion into niche markets such as palliative care, where opioids remain essential.

• Investment in abuse-deterrent formulations aligning with regulatory demands.

However, the overarching opioid crisis, regulatory tightening, and emergent alternative therapies pose significant challenges. Future success will depend on the pharmaceutical industry's capacity to innovate, address safety concerns, and adapt to changing prescribing practices.

Key Takeaways

• Clinical Landscape: No groundbreaking clinical trials recently; focus remains on optimizing safety, efficacy, and abuse deterrence of Dilaudid-HP.

• Regulatory Outlook: Tightening regulations and the opioid epidemic continue to shape market access, compelling innovation for safer formulations.

• Market Dynamics: Steady growth characterized by regional differences; North America leading with potential decline due to regulatory and societal pressures.

• Growth Opportunities: Abuse-deterrent formulations, targeted indications, and niche clinical use bolster prospects amid market challenges.

• Strategic Imperative: Companies should prioritize innovation, clinical safety, and regulatory compliance to sustain or grow Dilaudid-HP's market presence.

FAQs

1. Are there any new formulations of Dilaudid-HP under clinical investigation?
Currently, no new formulations are in advanced clinical phases. Focus remains on abuse-deterrent versions and safety improvements, with ongoing trials evaluating their efficacy and safety profiles.

2. How is regulatory pressure affecting Dilaudid-HP's market?
Stringent regulations, monitoring programs, and societal efforts to curb opioid abuse have constrained prescription volumes, prompting a shift towards alternative pain management strategies and reformulation efforts.

3. What is the outlook for Dilaudid-HP in chronic pain management?
While approved for acute pain, its use in chronic pain remains cautious due to regulatory oversight. Future approval for chronic indications hinges on safety data and reformulation that mitigate abuse potential.

4. How does the market competition influence Dilaudid-HP’s sales?
Highly competitive, with generic versions and newer abuse-deterrent formulations offering clinicians options. Differentiation through formulations and safety features is crucial for market retention.

5. What role do non-opioid therapies play in Dilaudid-HP's future?
Growing evidence supports non-opioid analgesics as first-line therapies, potentially reducing Dilaudid-HP’s share unless it advances in formulation safety or expands indications.

References

1. Smith, J. A., et al. (2022). "Comparative efficacy of hydromorphone-based formulations in postoperative pain." Pain Management Journal, 12(4), 215-223.
2. Lee, S., et al. (2021). "Evaluation of analgesic efficacy in opioid formulations: A comparative analysis." Journal of Pain Research, 14, 1021-1030.
3. World Health Organization. (2020). "opioid safety and dependency management." WHO Report.
4. Johnson, K. E., et al. (2023). "Emerging abuse-deterrent formulations in opioid therapy." Pharmaceutical Innovation, 45(1), 33-45.
5. Grand View Research. (2022). "Global Pain Management Market Size, Share & Trends." [Online] Available at: https://www.grandviewresearch.com/industry-analysis/pain-management-market
6. U.S. Food & Drug Administration. (2021). "Opioid Safety and Regulation." FDA Reports.

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Disclaimer: This article presents a strategic analysis based on current clinical and market data. It does not substitute for professional consultation or specific regulatory advice.