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 That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated.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.

Clinical Trial Conditions for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Condition Name

Condition Name for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Intervention	Trials
Pain	10
Pain, Postoperative	6
Postoperative Pain	5

Condition MeSH

Condition MeSH for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Intervention	Trials
Pain, Postoperative	15
Osteoarthritis	8
Chronic Pain	7

Clinical Trial Locations for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Trials by Country

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Trials by Country for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Location	Trials
United States	29
Canada	7
Korea, Republic of	5
Turkey	5
Italy	5

Trials by US State

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−

Trials by US State for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Location	Trials
Texas	4
Minnesota	2
Massachusetts	2
Florida	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
Phase 4	36
Phase 3	16
Phase 2	6

Clinical Trial Status

Clinical Trial Status for TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Clinical Trial Phase	Trials
Completed	51
Not yet recruiting	10
Recruiting	9

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	67
Industry	39
U.S. Fed	6

Tramadol Hydrochloride and Acetaminophen: Clinical Trials, Market Analysis, and Projections

Introduction

Tramadol hydrochloride and acetaminophen, a combination of an opioid analgesic and a non-opioid pain reliever, is widely used for managing moderate to severe pain. This article delves into the clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials and Efficacy

Chronic Low Back Pain Study

A significant clinical trial evaluated the efficacy and safety of extended-release tramadol hydrochloride 75-mg/acetaminophen 650-mg fixed-dose combination tablets (TA-ER) for treating chronic low back pain. This Phase III, double-blind, placebo-controlled study involved 245 patients with moderate to severe chronic low back pain. The results showed that TA-ER was significantly more effective than placebo in providing pain relief, functional improvements, and enhanced quality of life. The pain intensity change rate was higher in the TA-ER group, and patients experienced significant improvements in role-physical, general health, and reported health transition domains[1].

Comparative Studies

Other studies have compared the analgesic effects of tramadol hydrochloride with other pain management drugs. For instance, a randomized, double-blind study compared tramadol hydrochloride with hydrocodone-acetaminophen in patients with acute musculoskeletal pain. While tramadol hydrochloride showed efficacy, it was found to be less effective than hydrocodone-acetaminophen in managing acute pain, with more frequent side effects such as dizziness, nausea, and constipation[4].

Market Analysis

Global Market Size and Growth

The global tramadol market, which includes tramadol hydrochloride and acetaminophen combinations, was valued at USD 4.24 billion in 2023 and is expected to grow at a CAGR of 6.86% from 2024 to 2030, reaching nearly USD 6.75 billion by 2030[2].

Market Drivers

Several factors drive the growth of the tramadol market:

• Increasing Prevalence of Chronic Pain: The rising number of chronic disease cases and surgeries, particularly among aging populations, increases the demand for effective pain management solutions like tramadol hydrochloride and acetaminophen[3].
• Advancements in Drug Formulations: Innovations in drug delivery systems, such as extended-release formulations and combination therapies, enhance patient compliance and efficacy. For example, the FDA approved a co-formulated celecoxib and tramadol for acute pain management in adults, which has boosted market growth[2].
• Regulatory Approvals: New indications and regulatory approvals expand the utility of tramadol, tapping into unmet medical needs and diversifying its applications[3].

Regional Growth

The Asia Pacific region is witnessing rapid growth in the tramadol market due to improving healthcare infrastructure, rising disposable incomes, and increasing awareness about pain management. Emerging markets like China and India offer substantial growth opportunities due to their large and diverse patient populations[2].

Market Projections

Future Growth Trends

The tramadol market is expected to continue its growth trajectory driven by several factors:

• Increasing Research and Development: Ongoing research and development initiatives aim to enhance delivery efficacy and address the limitations associated with tramadol. This includes exploring new therapeutic indications and developing novel formulations[3].
• Digital Health Solutions: The adoption of digital health solutions is shaping the future of the tramadol market, particularly in regions like the Asia Pacific[2].
• Regulatory Frameworks: Stringent regulatory frameworks, especially in the United States, monitor tramadol closely due to its potential for abuse and dependence. This scrutiny helps maintain trust among healthcare providers and patients[2].

Adverse Events and Safety Profile

While tramadol hydrochloride and acetaminophen are effective, they are associated with several adverse events. Common side effects include nausea, dizziness, constipation, and vomiting. These side effects were more frequently reported in the TA-ER group compared to the placebo group in clinical trials[1].

Key Players and Market Competition

The tramadol market is dominated by leading pharmaceutical companies such as Pfizer, Johnson & Johnson, and Teva Pharmaceuticals. These companies leverage their extensive distribution networks and strong R&D capabilities to maintain a competitive advantage[2].

Conclusion

Tramadol hydrochloride and acetaminophen remain a crucial combination in pain management, backed by robust clinical evidence and a growing market. The combination's efficacy in treating chronic and acute pain, coupled with advancements in drug formulations and regulatory approvals, positions it for continued market growth.

Key Takeaways

• Clinical Efficacy: Tramadol hydrochloride and acetaminophen combinations have shown significant efficacy in managing chronic low back pain and other pain conditions.
• Market Growth: The global tramadol market is projected to grow at a CAGR of 6.86% from 2024 to 2030.
• Regional Expansion: The Asia Pacific region is a key growth area due to improving healthcare infrastructure and increasing awareness about pain management.
• Adverse Events: Common side effects include nausea, dizziness, constipation, and vomiting.
• Regulatory Approvals: New indications and regulatory approvals are driving market expansion.

FAQs

What is the current market size of the tramadol market?

The global tramadol market was valued at USD 4.24 billion in 2023[2].

What is the expected CAGR for the tramadol market from 2024 to 2030?

The tramadol market is expected to grow at a CAGR of 6.86% from 2024 to 2030[2].

Which regions are driving the growth of the tramadol market?

The Asia Pacific region is witnessing rapid growth due to improving healthcare infrastructure and increasing awareness about pain management[2].

What are the common adverse events associated with tramadol hydrochloride and acetaminophen?

Common side effects include nausea, dizziness, constipation, and vomiting[1].

Which companies are the key players in the tramadol market?

Leading companies include Pfizer, Johnson & Johnson, and Teva Pharmaceuticals[2].

Sources

1. PubMed: A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of the extended-release tramadol hydrochloride/acetaminophen fixed-dose combination tablets (TA-ER) for the treatment of chronic low back pain.
2. Stellar Market Research: Tramadol Market: Global Industry Analysis and Forecast (2024-2030).
3. Fortune Business Insights: Tramadol Market Size, Share, Forecast | Growth Report [2032].
4. American Academy of Family Physicians: Efficacy of Tramadol vs. Hydrocodone-Acetaminophen.