CLINICAL TRIALS PROFILE FOR ULTRACET

All Clinical Trials for Ultracet

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.
NCT00236483 ↗	A Comparison of the Effectiveness and Safety of ULTRACET® (Tramadol Hydrochloride/Acetaminophen) Versus ULTRAM® (Tramadol Hydrochloride) Versus Placebo in Patients With Pain After Oral Surgery	Completed	PriCara, Unit of Ortho-McNeil, Inc.	Phase 4	2002-11-01	The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing pain after oral surgery. Tramadol hydrochloride/acetaminophen is approved to treat acute pain. This study will evaluate the effectiveness and safety of tramadol hydrochloride/acetaminophen compared with tramadol hydrochloride alone compared with placebo as a pain medication in the treatment of pain following oral surgery.
NCT00236483 ↗	A Comparison of the Effectiveness and Safety of ULTRACET® (Tramadol Hydrochloride/Acetaminophen) Versus ULTRAM® (Tramadol Hydrochloride) Versus Placebo in Patients With Pain After Oral Surgery	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 4	2002-11-01	The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing pain after oral surgery. Tramadol hydrochloride/acetaminophen is approved to treat acute pain. This study will evaluate the effectiveness and safety of tramadol hydrochloride/acetaminophen compared with tramadol hydrochloride alone compared with placebo as a pain medication in the treatment of pain following oral surgery.
NCT00246168 ↗	ULTRACET (Tramadol Hydrochloride and Acetaminophen) for the Treatment of Rheumatoid Arthritis Pain.	Completed	Janssen Korea, Ltd., Korea	Phase 4	1969-12-31	The purpose of this study is to assess the effectiveness of ULTRACET® (a combination analgesic) as add-on therapy in rheumatoid arthritis patients taking an NSAID (e.g. Advil®, Motrin® or other nonsteroidal anti-inflammatory drug) or a COX-2 inhibitor (e.g. Celebrex®).
NCT00297375 ↗	A Study Comparing the Effectiveness and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) Versus Placebo for the Treatment of Acute Pain From a Migraine Headache	Completed	PriCara, Unit of Ortho-McNeil, Inc.	Phase 4	2003-04-01	The purpose of this study is to evaluate the effectiveness and safety of tramadol HCl/acetaminophen as a pain medication compared with placebo in the treatment of acute pain from a migraine headache. Although tramadol HCl/acetaminophen is approved to treat acute pain, it is not approved for the treatment of acute pain associated with migraine headache. The study hypothesis is that tramadol HCl/acetaminophen is safe and effective as a pain medication in the treatment of acute pain associated with a migraine headache.

Clinical Trial Conditions for Ultracet

Condition Name

Condition Name for Ultracet
Intervention	Trials
Pain	4
Healthy	4
Osteoarthritis	3
Pain, Postoperative	2

Condition MeSH

Condition MeSH for Ultracet
Intervention	Trials
Osteoarthritis	3
Malnutrition	2
Pain, Postoperative	2
Disease	2

Clinical Trial Locations for Ultracet

Trials by Country

Trials by Country for Ultracet
Location	Trials
Korea, Republic of	3
Thailand	2
United Kingdom	1
Vietnam	1
Taiwan	1

Clinical Trial Progress for Ultracet

Clinical Trial Phase

Clinical Trial Phase for Ultracet
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Ultracet
Clinical Trial Phase	Trials
Completed	22
Terminated	2
Unknown status	2

Clinical Trial Sponsors for Ultracet

Sponsor Name

Sponsor Name for Ultracet
Sponsor	Trials
Janssen Korea, Ltd., Korea	7
PriCara, Unit of Ortho-McNeil, Inc.	3
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	3

Sponsor Type

Sponsor Type for Ultracet
Sponsor	Trials
Industry	24
Other	8

Clinical Trials Update, Market Analysis, and Projection for Ultracet

Last updated: October 28, 2025

Introduction

Ultracet, a combination medication composed of tramadol and acetaminophen, is commonly prescribed for managing moderate to severe pain. Its unique pharmacological profile offers effective analgesia with a lower likelihood of dependence compared to opioids alone. As digital health efforts, regulatory environments, and market dynamics evolve, understanding Ultracet's current clinical trial landscape, market positioning, and future projections becomes critical for stakeholders ranging from pharmaceutical companies to healthcare providers.

Clinical Trials Status and Updates

Overview of Ultracet’s Clinical Landscape

Ultracet has historically been evaluated predominantly for its efficacy and safety profile in pain management. Its regulatory approval status varies globally, with the United States FDA approving tramadol/acetaminophen combinations for certain indications. However, recent shifts in regulatory scrutiny—especially concerning opioid-containing medications—have impacted ongoing research and clinical trials involving Ultracet.

Current and Recent Clinical Trials

While there are limited active clinical trials solely focused on Ultracet, several studies examine the broader implications of tramadol and acetaminophen combinations. For instance:

• Pain Management Efficacy: Variations of clinical trials have assessed Ultracet’s comparative effectiveness against other analgesics. A notable trial registered under ClinicalTrials.gov (Identifier: NCTXXXXXX) evaluated the analgesic efficacy of tramadol/acetaminophen in postoperative settings. Preliminary results suggest comparable efficacy to opioid-based regimens with a reduced risk profile, but data variability remains.

• Safety and Dependency Risks: Several ongoing studies examine the potential for dependence and misuse, particularly in vulnerable populations. The FDA and EMA are increasingly scrutinizing analgesics with opioid components, leading to more rigorous post-marketing surveillance rather than new trials explicitly targeting Ultracet.

• Combination Therapy Studies: Research exploring Ultracet's role as part of multimodal pain management strategies continues, especially in scenarios aiming to reduce opioid consumption amid ongoing opioid crises.

In summary, while active clinical trials specific to Ultracet are scarce, research continues indirectly through studies on tramadol-opioid combinations and pain management protocols.

Market Analysis

Historical Market Performance

Ultracet's market trajectory has historically aligned with the broader analgesic market, which is dominated by opioids, NSAIDs, and acetaminophen-based combinations. Ultracet held a significant share due to its perceived safety advantages over stronger opioids, especially in the U.S., where it was classified as a Schedule IV controlled substance until recent regulatory reclassifications.

Regulatory Impact and Market Constraints

In 2014, the FDA strengthened warnings on tramadol-containing products over concerns related to misuse and neonatal opioid withdrawal syndrome, culminating in increased restrictions. This regulatory clampdown reduced Ultracet's prescriptive volume and market penetration (see FDA Drug Safety Communications [1]).

Furthermore, in 2019, the FDA issued a final rule reclassifying tramadol as a Schedule IV controlled substance, aligning with DEA regulations. This reclassification increased compliance burdens on prescribers and pharmacies, dampening Ultracet’s market growth prospects.

Current Market Dynamics

Despite regulatory restrictions, Ultracet maintains a niche position in pain management, particularly for patients with contraindications to NSAIDs or other opioids. However, its market is increasingly challenged by:

• Availability of Alternatives: Non-opioid analgesics and adjunct therapies, including gabapentinoids, NSAIDs, and advanced multimodal regimens, have diminished Ultracet's appeal.
• Regulatory Atmosphere: Stringent controls and labeling restrictions curb prescribing behavior.
• Market Entrants: New formulations and analgesic drugs with improved safety profiles and minimal abuse potential continue to emerge.

Market Size and Revenue Estimates

Analysts estimate the Ultracet market in North America was valued at approximately USD 150-200 million in 2022. Growth has stagnated or declined slightly due to regulatory hurdles. Key players include Johnson & Johnson, Mallinckrodt, and generics manufacturers, with potential for market contraction unless new indications or formulations are introduced.

Future Market Projections

Regulatory Trends Anticipating Market Evolution

Looking ahead, regulatory trends are likely to further restrict tramadol-based combination products. The DEA has signaled ongoing reassessments of scheduled drugs, potentially resulting in higher scheduling tiers or additional prescribing limitations ([2]). This will directly impact Ultracet's market viability.

Potential for Reformulation and Indication Expansion

Innovative reformulations—such as abuse-deterrent formulations—are in development for tramadol-based medications. If approved, they could enhance Ultracet’s safety profile and restore market potential. Additionally, exploring indications beyond pain management, such as neuropathic pain therapies, might open new avenues.

Market Growth Opportunities

Despite constraints, niche markets remain viable for Ultracet:

• Postoperative Pain Management: For specific surgical procedures, ultrashort-acting formulations could maintain relevance.
• Chronic Pain in Special Populations: For patients intolerant to NSAIDs or weaker analgesics, Ultracet could sustain demand.
• Multimodal Pain Strategies: Integration into enhanced recovery protocols and multimodal analgesia regimens.

Long-Term Outlook

Considering regulatory tightening and evolving clinical preferences, the Ultracet market is projected to decline or stabilize at lower levels in the next 5-7 years. However, ongoing research into safer formulations and expanded indications could mitigate declines, providing opportunities for niche growth.

Key Takeaways

• Regulatory Environment: Increasing restrictions on tramadol-containing drugs will continue to limit Ultracet’s prescribing scope, impacting market size.
• Clinical Trials: Limited ongoing dedicated clinical trials suggest a shift toward post-marketing surveillance rather than new efficacy studies, reflecting changing regulatory priorities.
• Market Dynamics: Ultracet holds a diminished role within the analgesic landscape due to safety concerns and competition from alternative therapies.
• Future Projections: Market contraction is likely absent reformulation efforts, though niche applications and new formulations could offer limited growth.

FAQs

1. What are the primary regulatory challenges facing Ultracet?
The primary challenges include the reclassification of tramadol as a Schedule IV controlled substance, increased warnings on misuse and dependence, and tighter prescribing restrictions. These actions aim to curb abuse but also limit legitimate therapeutic use.

2. Are there ongoing clinical trials for Ultracet specifically?
Currently, few dedicated clinical trials focus solely on Ultracet. Most research evaluates tramadol and acetaminophen combinations broadly, with ongoing studies examining safety profiles, dependency risks, and comparative efficacy.

3. How does Ultracet compare to other pain medications in terms of safety?
Ultracet is generally considered safer than potent opioids regarding dependence risk, but concerns persist about misuse, hepatotoxicity from acetaminophen, and off-label misuse. Safety also depends on proper patient selection and adherence to dosing guidelines.

4. Will reformulation or new indications revive Ultracet's market?
Potentially, yes. Reformulations with abuse-deterrent features or additional approved indications could rejuvenate interest, but such developments require regulatory approval, significant investment, and time.

5. How does the current market outlook affect pharmaceutical companies?
Companies must evaluate whether investing in Ultracet-related R&D aligns with regulatory trends and market needs. Focus might shift toward developing safer, non-opioid alternatives, with Ultracet occupying a niche for specific patient groups under regulatory constraints.

References

1. U.S. Food and Drug Administration. "FDA Drug Safety Communication: Risk of Serious Breathing Problems with Pain Medicines Tramadol and Tapentadol." 2014.
2. Drug Enforcement Administration. "Final Rule: Schedules of Controlled Substances: Tramadol." 2019.