CLINICAL TRIALS PROFILE FOR TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

505(b)(2) Clinical Trials for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

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	NCT01588158 ↗	Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery	Terminated	Massachusetts General Hospital	Phase 4	2012-07-01	Adequate pain relief has been a priority of the Joint Commission and is featured on national inpatient surveys such as the H-CAHPS. When considering methods for improving satisfaction with pain relief in the United States, a great deal of emphasis has been placed on opioid pain medications. Some of this emphasis on opioid pain medication is driven by the pharmaceutical industry and by advocacy groups with ties to the pharmaceutical industry. There is evidence that the "pain is the fifth vital sign" campaign of the Joint Commission led to an increased incidence of prescription of opioids, but there is less evidence of improved satisfaction with pain relief. There is some evidence of an increase in opioid-related adverse events. As the sales of opioids have tripled from 1999-2008, so has the number of deaths caused by opioid overdose; 14,800 in 2008. The number of visits to the Emergency Department for opioid overdose doubled between 2004 and 2008. Patients in other countries take far less opioid pain medication and are equally satisfied with pain relief. For instance, Lindenhovius et al. found in a retrospective study that Dutch patients take a weak (Tramadol) or no opioid pain medication after ankle fracture surgery and have comparable or better satisfaction with pain relief than American patients, most of whom take oxycodone. That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated. A study of morphine use after a femur fracture demonstrated that American patients used far more than Vietnamese patients (30 mg/kg versus 0.9 mg/kg), but were more dissatisfied with their pain relief. These sociological differences are striking and suggest strongly that personal factors may be the most important determinant of satisfaction with pain relief. It is our impression that most American hand surgeons give patients a prescription for an opioid pain medication after carpal tunnel release, and that is certainly true in our practice. This seems to be based primarily on the outliers, and intended to avoid confrontation with patients that desire opioids; however, most patients take little or no narcotic pain medication, and many who do use the opioids complain of the side effects-nausea and pruritis in particular. It is therefore not clear whether routine opioids is the optimal pain management strategy after carpal tunnel release. In the study of Stahl et al. from Israel, patients were prescribed acetaminophen rather than opioids after carpal tunnel release and only 20 of 50 patients used acetaminophen; 30 patients did not use acetaminophen or other pain medication at all after the operation. Our aim is to determine if there is a difference in satisfaction with pain relief between patients advised to take opioids compared to patients advised to use over the counter acetaminophen after carpal tunnel release under local anesthesia. A secondary aim is to determine if personal factors account for more of the variability in satisfaction with pain relief than opioid strategy.

All Clinical Trials for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00210561 ↗	A Study of the Effectiveness and Safety of Tramadol HCl/Acetaminophen Compared to Placebo in Treating Acute Low Back Pain	Terminated	PriCara, Unit of Ortho-McNeil, Inc.	Phase 4	2005-03-01	The purpose of this study is to explore the pain-relieving effects and safety of Tramadol HCl/acetaminophen as compared to placebo in patients experiencing acute low back pain. Tramadol HCl/acetaminophen is approved for short-term management of acute pain. The combination of tramadol HCl/acetaminophen has been shown to be effective for the treatment of acute musculoskeletal pain. Patients who experienced at least moderate acute low back pain for 2 to 10 days before study entry will be randomized to receive either tramadol HCl/acetaminophen or placebo.
NCT00210561 ↗	A Study of the Effectiveness and Safety of Tramadol HCl/Acetaminophen Compared to Placebo in Treating Acute Low Back Pain	Terminated	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 4	2005-03-01	The purpose of this study is to explore the pain-relieving effects and safety of Tramadol HCl/acetaminophen as compared to placebo in patients experiencing acute low back pain. Tramadol HCl/acetaminophen is approved for short-term management of acute pain. The combination of tramadol HCl/acetaminophen has been shown to be effective for the treatment of acute musculoskeletal pain. Patients who experienced at least moderate acute low back pain for 2 to 10 days before study entry will be randomized to receive either tramadol HCl/acetaminophen or placebo.
NCT00210847 ↗	A Study Comparing the Effectiveness and Safety of Tramadol HCl/Acetaminophen Versus Placebo for the Treatment of Painful Neuropathy in Diabetic Patients	Completed	PriCara, Unit of Ortho-McNeil, Inc.	Phase 3	2003-12-01	The purpose of this study is to explore the pain-reieiving effects and safety of tramadol HCl/acetaminophen as compared to placebo in patients experiencing painful diabetic neuropathy. Treatment of neuropathic pain often requires the use of more than one medication. The pain-relieving potential of tramadol HCl/acetaminophen for the treatment of painful diabetic neuropathy comes from the multiple mechanisms of action in this combination pain medication. Patients who experience painful diabetic neuropathy will be enrolled in this study.
NCT00210847 ↗	A Study Comparing the Effectiveness and Safety of Tramadol HCl/Acetaminophen Versus Placebo for the Treatment of Painful Neuropathy in Diabetic Patients	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2003-12-01	The purpose of this study is to explore the pain-reieiving effects and safety of tramadol HCl/acetaminophen as compared to placebo in patients experiencing painful diabetic neuropathy. Treatment of neuropathic pain often requires the use of more than one medication. The pain-relieving potential of tramadol HCl/acetaminophen for the treatment of painful diabetic neuropathy comes from the multiple mechanisms of action in this combination pain medication. Patients who experience painful diabetic neuropathy will be enrolled in this study.

Clinical Trial Conditions for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Condition Name

Condition Name for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Intervention	Trials
Pain	10
Pain, Postoperative	8
Postoperative Pain	5
Chronic Pain	5

Condition MeSH

Condition MeSH for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Intervention	Trials
Pain, Postoperative	18
Osteoarthritis	8
Chronic Pain	8
Low Back Pain	7

Clinical Trial Locations for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Trials by Country

Trials by Country for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Location	Trials
United States	34
Canada	7
Korea, Republic of	5
Turkey	5
Italy	5

Trials by US State

Trials by US State for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Location	Trials
Texas	7
Florida	3
Minnesota	2
Massachusetts	2
New York	2

Clinical Trial Progress for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Clinical Trial Phase

Clinical Trial Phase for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	2
PHASE1	1

Clinical Trial Status

Clinical Trial Status for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Clinical Trial Phase	Trials
Completed	52
Recruiting	11
Not yet recruiting	10

Clinical Trial Sponsors for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Sponsor Name

Sponsor Name for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Sponsor	Trials
Janssen Korea, Ltd., Korea	10
PriCara, Unit of Ortho-McNeil, Inc.	5
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	5

Sponsor Type

Sponsor Type for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Sponsor	Trials
Other	75
Industry	39
U.S. Fed	6

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN Market Analysis and Financial Projection

Last updated: April 28, 2026

Tramadol Hydrochloride and Acetaminophen: Clinical Trial Update, Market Analysis, and Projection

What is the current clinical-trial landscape for tramadol HCl and acetaminophen (combination)?

Tramadol hydrochloride and acetaminophen is an established fixed-dose oral combination approved for the management of pain. It is generally used in postmarketing real-world practice rather than as the centerpiece of large-scale, brand-new pivotal programs. In the absence of a defined, current clinical-trial tranche (phase-by-phase enrollment, trial IDs, endpoints, and status dates), a complete, verifiable “clinical trials update” cannot be produced in a way that is accurate and decision-grade for R&D or investment.

What is the market structure and where does pricing power come from?

The combination is typically positioned in the prescription analgesic market alongside other opioid-based and non-opioid pain therapies. The key market drivers are standard-of-care prescribing patterns for moderate-to-moderate pain, payer restrictions, and substitution risk from generics and alternative analgesics.

Market structure (high-level, product category level)

• Core demand segment: outpatient pain management where prescribers choose combination analgesics for perceived efficacy and dose-convenience.
• Supply reality: widespread generic availability tends to compress pricing and limit long-term margin expansion unless managed by differentiated formulation, distribution contracts, or protected labels.
• Competitive set: other fixed-dose analgesic combinations, single-ingredient opioids (where available under payer rules), and non-opioid alternatives (NSAIDs, acetaminophen monotherapy, adjuvant classes).

Primary levers affecting commercial trajectory

• Formulary access: payer step edits, quantity limits, prior authorization thresholds.
• Safety and abuse-schedule dynamics: tramadol-related restrictions and insurer policies that steer utilization.
• Substitution: interchangeability with generic tramadol/acetaminophen products and other analgesics.
• Prescriber behavior: guideline adherence and opioid stewardship programs.

What does the near-term revenue outlook look like?

A projection requires (1) current sales baseline by geography, (2) category and competitor dynamics, and (3) likely pipeline events (new formulations, label expansions, or patent-protected exclusivity). None of those baseline inputs are provided here with source-backed figures, so a complete and accurate numerical forecast cannot be produced.

Which factors will most likely influence demand for the combination?

Even without a numeric forecast, demand direction is usually shaped by the following commercial constraints.

Demand tailwinds

• Convenience and perceived efficacy: fixed-dose compliance and simplified dosing.
• Broad clinical applicability within analgesic pathways: moderate pain use cases.

Demand headwinds

• Opioid stewardship and payer friction: controls that reduce eligible prescriber and patient populations.
• Generics and price competition: pressure that limits unit-price growth.
• Safety monitoring requirements: utilization may tighten where adverse-effect profiles lead to more cautious prescribing.

How should R&D and investment teams think about “what’s left to win”?

Where combination products are mature and generic competition is heavy, remaining value creation typically comes from one of three pathways:

1. Formulation differentiation
   Example levers include improved tolerability, extended-release formats, or abuse-deterrent delivery systems.
2. Access strategy
   Contracts that preserve net pricing through payer-specific reimbursement pathways.
3. Evidence-led differentiation
   Real-world effectiveness or safety outcomes tied to specific patient subgroups and endpoints that payers and health systems can act on.

Without a current development inventory (trial IDs, phases, endpoints, design, and timelines) for tramadol HCl/acetaminophen, it is not possible to map “clinical-trial update” to “market projection” with verifiable linkage.

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Clinical Trial Update: What can be stated with proof?

No source-backed, date-stamped clinical trial specifics (current trials, recruitment status, primary endpoints, or results) are available in the provided information. A complete, accurate update cannot be delivered.

Market Analysis and Projection: What can be stated with proof?

No current-year sales baseline, market size by region, or forecast inputs are provided, so a numerical projection cannot be generated without risking inaccuracy.

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Key Takeaways

• Tramadol hydrochloride and acetaminophen is a mature oral analgesic combination; market outcomes depend primarily on payer access, substitution pressure, and opioid stewardship controls.
• A decision-grade clinical trial update and a quantified market projection require source-backed trial and sales baseline inputs that are not present here.
• The most realistic value creation channels in mature combination analgesics are formulation differentiation, access strategy, and evidence-led payer-relevant outcomes.

FAQs

1. Is tramadol hydrochloride and acetaminophen still being studied in new pivotal clinical trials?
   Not enough sourced, current trial-status detail is provided to confirm ongoing pivotal programs.

2. What typically drives payer restrictions for tramadol/acetaminophen combinations?
   Opioid stewardship policies, safety considerations, and utilization controls (quantity limits and prior authorization).

3. How does generic competition affect profitability for this combination?
   It typically compresses net price and limits long-term revenue growth unless differentiated via access or formulation.

4. What R&D approaches can still create value for mature analgesic combinations?
   Formulation differentiation, abuse-deterrent or tolerability improvements, and evidence that supports payer-relevant outcomes.

5. Can a reliable market forecast be produced without current sales baselines?
   No. A credible projection requires a current revenue baseline and forecast drivers with verifiable sources.

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References

No sources were provided in the prompt, and no verifiable external trial or market figures can be cited without additional input.