CLINICAL TRIALS PROFILE FOR ULTRAM ER

505(b)(2) Clinical Trials for ULTRAM ER

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	NCT04694300 ↗	OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients	Recruiting	Bayer	Phase 4	2021-02-07	This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.
OTC	NCT04694300 ↗	OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients	Recruiting	University of Pennsylvania	Phase 4	2021-02-07	This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.
OTC	NCT04694300 ↗	OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients	Recruiting	Hersh, Elliot V., DMD, MS, PhD	Phase 4	2021-02-07	This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.

All Clinical Trials for ULTRAM ER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00290901 ↗	Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.	Completed	Pfizer	Phase 4	2006-03-01	This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period.
NCT00290901 ↗	Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 4	2006-03-01	This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period.
NCT00301210 ↗	Assessment of Tramadol as a Treatment for Opioid Addiction	Completed	National Institute on Drug Abuse (NIDA)	Phase 1/Phase 2	2006-01-01	Opioids are one of the most commonly abused drugs among individuals who seek treatment for drug abuse. Thus, it is necessary to develop new treatments for opioid addiction. The purpose of this trial is determine whether tramadol is effective in treating opioid dependent individuals.
NCT00301210 ↗	Assessment of Tramadol as a Treatment for Opioid Addiction	Completed	Johns Hopkins University	Phase 1/Phase 2	2006-01-01	Opioids are one of the most commonly abused drugs among individuals who seek treatment for drug abuse. Thus, it is necessary to develop new treatments for opioid addiction. The purpose of this trial is determine whether tramadol is effective in treating opioid dependent individuals.
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.

Clinical Trial Conditions for ULTRAM ER

Condition Name

Condition Name for ULTRAM ER
Intervention	Trials
Pain	6
Shoulder Pain	2
Healthy	2
Pain, Postoperative	2

Condition MeSH

Condition MeSH for ULTRAM ER
Intervention	Trials
Opioid-Related Disorders	3
Shoulder Pain	2
Pain, Postoperative	2
Hemorrhoids	1

Clinical Trial Locations for ULTRAM ER

Trials by Country

+

−

Trials by Country for ULTRAM ER
Location	Trials
United States	37
Puerto Rico	1
Denmark	1

Trials by US State

+

−

Trials by US State for ULTRAM ER
Location	Trials
Maryland	4
Illinois	3
Utah	2
Minnesota	2
Pennsylvania	2

Clinical Trial Progress for ULTRAM ER

Clinical Trial Phase

Clinical Trial Phase for ULTRAM ER
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ULTRAM ER
Clinical Trial Phase	Trials
Completed	13
Recruiting	4
Unknown status	2

Clinical Trial Sponsors for ULTRAM ER

Sponsor Name

Sponsor Name for ULTRAM ER
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	4
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	3
Johns Hopkins University	2

Sponsor Type

Sponsor Type for ULTRAM ER
Sponsor	Trials
Other	16
Industry	13
NIH	4

ULTRAM ER (Tramadol HCl Extended-Release): Clinical Trials, Market Analysis, and Projections

Introduction to ULTRAM ER

ULTRAM ER, an extended-release formulation of tramadol hydrochloride, is designed for the management of moderate to moderately severe chronic pain in adults. This medication is particularly useful for patients who require around-the-clock pain treatment for an extended period.

Clinical Trials and Efficacy

Clinical trials have been instrumental in establishing the efficacy and safety profile of ULTRAM ER.

• Osteoarthritis and Chronic Pain Studies: In two 12-week randomized, double-blind, placebo-controlled studies, patients with osteoarthritis of the knee and/or hip were administered ULTRAM ER doses ranging from 100 mg to 400 mg daily. These studies demonstrated a statistically significant improvement in pain for the 100 mg and 200 mg treatment groups compared to placebo, as measured by the WOMAC Pain subscale and visual analog scale (VAS) scores[1][4].

• Flexible-Dosing Trial: A 12-week flexible-dosing trial in patients with osteoarthritis of the knee showed that patients titrated to an average daily dose of approximately 270 mg/day of ULTRAM ER had a statistically significant decrease in VAS scores and a higher responder rate compared to the placebo group[1].

• Adverse Events: The frequency of adverse events, such as dizziness, nausea, and constipation, generally increased with higher doses of ULTRAM ER. However, these events were more common in the treatment groups than in the placebo group[1][4].

Market Analysis

The global tramadol market, which includes ULTRAM ER, is experiencing significant growth driven by several key factors.

Market Size and Growth

• The global tramadol market was valued at $2.11 billion in 2023 and is projected to grow to $3.50 billion by 2032, with a compound annual growth rate (CAGR) of 5.8% during the forecast period[2].

• Another report indicates that the tramadol market size was valued at $4.24 billion in 2023 and is expected to grow at a CAGR of 6.86% from 2024 to 2030[3].

Driving Factors

• Increasing Prevalence of Chronic Diseases: The rise in chronic disease cases, such as neuropathic pain, dental pain, and pain associated with surgeries, is driving the demand for tramadol. Lifestyle changes and an aging population globally contribute to this trend[2][3].

• Regulatory Approvals and New Indications: New regulatory approvals for various indications of tramadol, including its use in combination therapies, are expanding the market. For example, the FDA approved a co-formulated celecoxib and tramadol for acute pain in adults in 2021[2][3].

• Research and Development: Innovations in drug delivery systems, such as extended-release formulations and combination therapies, are enhancing patient compliance and efficacy. These advancements include enteric coatings for extended-release formulations and the development of novel products to address the limitations associated with tramadol[2][3].

Market Segmentation

• Dosage Forms: The tramadol market is segmented into tablets, capsules, liquids, suspensions, and other forms. The tablet segment, which includes ULTRAM ER, held the largest market share in 2023 due to its high efficacy, ease of manufacturing, convenience of dosing, and cost-effectiveness[3].

• Geographical Dominance: North America and Europe are the dominant regions for the tramadol market, driven by high healthcare expenditure and a large patient population with chronic pain conditions. Emerging markets include Asia-Pacific, Latin America, and the Middle East and Africa[2][5].

Projections and Future Outlook

Market Growth Projections

• The tramadol market is expected to continue growing at a moderate CAGR, driven by the increasing prevalence of chronic pain conditions, advancements in pain management techniques, and the development of new formulations and combination therapies[2][3].

• The rebound of the market to pre-pandemic levels in 2022, following the COVID-19 pandemic, indicates a strong recovery and potential for sustained growth[2].

Challenges and Opportunities

• Adverse Events and Regulatory Concerns: Despite the growth potential, the market faces challenges such as potential side effects and regulatory concerns. Ongoing research to improve the safety profile and efficacy of tramadol is crucial for market expansion[2][5].

• Innovations and Personalized Medicine: Advancements in personalized medicine, such as genetic testing to optimize tramadol dosage and identify patients at higher risk of adverse effects, offer opportunities for improved treatment outcomes and market differentiation[3].

Key Takeaways

• Clinical Efficacy: ULTRAM ER has demonstrated significant efficacy in managing moderate to moderately severe chronic pain in clinical trials.
• Market Growth: The global tramadol market, including ULTRAM ER, is projected to grow substantially due to increasing chronic disease prevalence, regulatory approvals, and innovations in drug delivery systems.
• Geographical Dominance: North America and Europe are the dominant regions, with emerging markets in Asia-Pacific, Latin America, and the Middle East and Africa.
• Challenges and Opportunities: The market faces challenges related to adverse events and regulatory concerns but offers opportunities through innovations and personalized medicine approaches.

FAQs

What is ULTRAM ER used for?

ULTRAM ER is used for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment for an extended period.

What are the common adverse events associated with ULTRAM ER?

Common adverse events include dizziness, nausea, and constipation, which generally increase with higher doses.

How is the global tramadol market expected to grow?

The global tramadol market is expected to grow from $2.11 billion in 2023 to $3.50 billion by 2032, with a CAGR of 5.8%.

What are the key driving factors for the tramadol market growth?

Key driving factors include the increasing prevalence of chronic diseases, new regulatory approvals, and innovations in drug delivery systems.

Which regions dominate the tramadol market?

North America and Europe are the dominant regions, with emerging markets in Asia-Pacific, Latin America, and the Middle East and Africa.

Sources

1. ULTRAM ER (tramadol HCI) Extended-Release Tablets Clean Proposed Labeling Text. FDA.
2. Tramadol Market Size, Share, Forecast | Growth Report [2032]. Fortune Business Insights.
3. Tramadol Market: Global Industry Analysis and Forecast (2024-2030). Stellar Market Research.
4. Ultram ER (Tramadol HCl Extended-Release) - RxList.
5. Deep Dive into Tramadol Hydrochloride for Injection. Data Insights Market.