CLINICAL TRIALS PROFILE FOR NAPRELAN

All Clinical Trials for Naprelan

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00778193 ↗	Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers	Completed	Research Associates of New York, LLP	Phase 4	2007-10-01	Gastroduodenal ulcers are extremely common in the community today. Though much has been written and observed concerning how ulcers form, not much has been described in the human model concerning how these ulcers heal. As numerous patients already suffer from gastrointestinal ulcers, further clarification of ulcer healing would be valuable in the treatment and management of these patients. The goal of this study is to investigate the effects of naproxen, aspirin, celecoxib, and clopidogrel on biopsy-induced gastroduodenal lesions in order to elucidate the mechanisms of ulcer healing. This single site, single-blind, randomized, placebo-controlled, one-week prospective study will examine ulcer healing through endoscopic, immunohistologic, and molecular PCR modalities.
NCT00969449 ↗	Pharmacokinetics Study Comparing Naproxen Sodium Extended Release and Naprelan	Completed	Bayer	Phase 1	2009-04-01	To compare the pharmacokinetic profile of the proposed extended- release tablet of naproxen sodium 660 mg relative to two tablets of Naprelan 500 mg following single dose administration for 36 hours under fasted conditions
NCT01442428 ↗	Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial	Withdrawn	Minnesota Medical Foundation	Phase 2/Phase 3	2014-01-01	Tuberculosis is the most common opportunistic infection (OI) in HIV-infected persons worldwide, including in South East Asia. Significant numbers of patients experience tuberculosis-related paradoxical immune reconstitution inflammatory syndrome (TB-IRIS) after ART initiation, yet the optimal treatment of TB-IRIS is unknown. A recent randomized-controlled trial showed the benefit of prednisone over placebo in reduction of days of hospitalization and invasive procedures. The investigators hypothesize that nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective as corticosteroids for treatment of non-life threatening TB-IRIS in HIV-infected patients and hypothesize that adjunctive treatment with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (Statins) may improve the outcomes. This is a randomized controlled trial with a 2x2 factorial design to test the relative benefit of corticosteroids, NSAIDS, and Statins for the symptomatic and immunologic control of TB-IRIS.
NCT01442428 ↗	Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial	Withdrawn	Pfizer	Phase 2/Phase 3	2014-01-01	Tuberculosis is the most common opportunistic infection (OI) in HIV-infected persons worldwide, including in South East Asia. Significant numbers of patients experience tuberculosis-related paradoxical immune reconstitution inflammatory syndrome (TB-IRIS) after ART initiation, yet the optimal treatment of TB-IRIS is unknown. A recent randomized-controlled trial showed the benefit of prednisone over placebo in reduction of days of hospitalization and invasive procedures. The investigators hypothesize that nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective as corticosteroids for treatment of non-life threatening TB-IRIS in HIV-infected patients and hypothesize that adjunctive treatment with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (Statins) may improve the outcomes. This is a randomized controlled trial with a 2x2 factorial design to test the relative benefit of corticosteroids, NSAIDS, and Statins for the symptomatic and immunologic control of TB-IRIS.
NCT01442428 ↗	Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial	Withdrawn	University of Minnesota	Phase 2/Phase 3	2014-01-01	Tuberculosis is the most common opportunistic infection (OI) in HIV-infected persons worldwide, including in South East Asia. Significant numbers of patients experience tuberculosis-related paradoxical immune reconstitution inflammatory syndrome (TB-IRIS) after ART initiation, yet the optimal treatment of TB-IRIS is unknown. A recent randomized-controlled trial showed the benefit of prednisone over placebo in reduction of days of hospitalization and invasive procedures. The investigators hypothesize that nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective as corticosteroids for treatment of non-life threatening TB-IRIS in HIV-infected patients and hypothesize that adjunctive treatment with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (Statins) may improve the outcomes. This is a randomized controlled trial with a 2x2 factorial design to test the relative benefit of corticosteroids, NSAIDS, and Statins for the symptomatic and immunologic control of TB-IRIS.
NCT01442428 ↗	Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial	Withdrawn	University of Minnesota - Clinical and Translational Science Institute	Phase 2/Phase 3	2014-01-01	Tuberculosis is the most common opportunistic infection (OI) in HIV-infected persons worldwide, including in South East Asia. Significant numbers of patients experience tuberculosis-related paradoxical immune reconstitution inflammatory syndrome (TB-IRIS) after ART initiation, yet the optimal treatment of TB-IRIS is unknown. A recent randomized-controlled trial showed the benefit of prednisone over placebo in reduction of days of hospitalization and invasive procedures. The investigators hypothesize that nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective as corticosteroids for treatment of non-life threatening TB-IRIS in HIV-infected patients and hypothesize that adjunctive treatment with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (Statins) may improve the outcomes. This is a randomized controlled trial with a 2x2 factorial design to test the relative benefit of corticosteroids, NSAIDS, and Statins for the symptomatic and immunologic control of TB-IRIS.
NCT01951105 ↗	Effect of L-dopa In Subacute Back Pain Population	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 4	2015-02-24	This study aims to determine if early treatment with Carbidopa/Levodopa and Naproxen in individuals with sub-acute back pain (SBP) is associated with changes in blocking transition to chronic back pain (CBP).

Clinical Trial Conditions for Naprelan

Condition Name

Condition Name for Naprelan
Intervention	Trials
Acute Pain	2
Chronic Low Back Pain	2
Bunionectomy	1
Gastroduodenal Ulcer	1

Condition MeSH

Condition MeSH for Naprelan
Intervention	Trials
Back Pain	3
Acute Pain	2
Low Back Pain	2
Pain, Postoperative	1

Clinical Trial Locations for Naprelan

Trials by Country

Trials by Country for Naprelan
Location	Trials
United States	6
Thailand	1

Trials by US State

Trials by US State for Naprelan
Location	Trials
Illinois	4
Texas	1
New York	1

Clinical Trial Progress for Naprelan

Clinical Trial Phase

Clinical Trial Phase for Naprelan
Clinical Trial Phase	Trials
Phase 4	4
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Naprelan
Clinical Trial Phase	Trials
Completed	4
Withdrawn	2
Not yet recruiting	1

Clinical Trial Sponsors for Naprelan

Sponsor Name

Sponsor Name for Naprelan
Sponsor	Trials
National Institutes of Health (NIH)	5
Northwestern University	4
National Institute of Dental and Craniofacial Research (NIDCR)	2

Sponsor Type

Sponsor Type for Naprelan
Sponsor	Trials
Other	10
NIH	9
Industry	2

NAPRELAN (Naproxen Sodium): Clinical Trials, Market Analysis, and Projections

Introduction to NAPRELAN

NAPRELAN, a formulation of naproxen sodium, is a non-steroidal anti-inflammatory drug (NSAID) widely used for the management of pain, inflammation, and various arthritic conditions. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Rheumatoid Arthritis and Osteoarthritis

Clinical trials have demonstrated the efficacy of NAPRELAN in managing the signs and symptoms of rheumatoid arthritis and osteoarthritis. A 12-week double-blind, randomized, placebo, and active-controlled study involving 348 patients with rheumatoid arthritis showed that NAPRELAN Tablets (1000 mg once daily) were more effective than placebo in reducing symptoms. Similar results were observed in a study involving 347 patients with osteoarthritis of the knee[4].

Analgesia

The analgesic effect of NAPRELAN Tablets was observed within 30 minutes in a pharmacokinetic/pharmacodynamic study of patients with pain following oral surgery. This rapid onset of action makes it a preferred option for acute pain management[4].

Combination Therapy

NAPRELAN has been used in combination with other medications such as gold, D-penicillamine, methotrexate, and corticosteroids. However, its use in combination with salicylate (aspirin) is not recommended due to the increased risk of adverse events and the lack of additional therapeutic benefit over aspirin alone[4].

Gastrointestinal Safety

Studies have shown that NAPRELAN Tablets may have a lower incidence of gastrointestinal erosions compared to traditional naproxen and aspirin. In a double-blind, randomized, crossover study, subjects receiving NAPRELAN Tablets had significantly fewer duodenal and gastric erosions than those receiving naproxen or aspirin[4].

Adverse Reactions

Clinical trials have identified several adverse reactions associated with NAPRELAN. The most frequent adverse events include headache (15%), dyspepsia (14%), and flu syndrome (10%). Other adverse events occurring in 3% to 9% of patients include dizziness, nausea, and abdominal pain[1].

Market Analysis

Global Market Size and Growth

The global market for naproxen, the active ingredient in NAPRELAN, is substantial and growing. In 2023, the global naproxen market volume was approximately 15 thousand tonnes and is anticipated to grow at a CAGR of 5.5% until 2034[2].

NSAIDs Market Overview

The broader NSAIDs market, which includes naproxen, was valued at USD 15.58 billion in 2019 and is projected to reach USD 32.33 billion by 2032. This growth is driven by the preference for NSAIDs over opioids due to the lower risk of severe adverse events associated with opioids[3].

Regional Market

North America is one of the prominent consumers of naproxen and NSAIDs in general. The NSAIDs market in North America was valued at USD 6.86 billion in 2019 and is expected to continue growing at a CAGR of 5.8% during the forecast period (2020-2027)[3].

Market Projections

Future Growth Drivers

The market for NAPRELAN and other NSAIDs is expected to grow due to several factors:

• Increasing Prevalence of Chronic Pain: The rising prevalence of chronic pain conditions, such as arthritis, will drive the demand for effective pain management solutions like NAPRELAN[3][5].
• Preference Over Opioids: The preference for NSAIDs over opioids due to safety concerns will continue to boost the market[3].
• Aging Population: An aging population will increase the demand for anti-inflammatory and analgesic medications[5].

Challenges and Opportunities

Despite the growth potential, the market faces challenges such as:

• Stringent Regulatory Policies: Regulatory scrutiny, especially regarding the cardiovascular risks associated with certain COX-2 inhibitors, may limit market growth[5].
• Development of Safer Drugs: The development of safer and more effective anti-inflammatory drugs presents opportunities for market expansion[5].

Key Players

Major pharmaceutical companies like GlaxoSmithKline plc and Pfizer Inc. are key players in the NSAIDs market, including the segment for naproxen and its formulations like NAPRELAN[3].

Research and Development

Research on developing selective COX-2 inhibitors is a significant trend in the NSAIDs market. These inhibitors aim to reduce the gastrointestinal side effects associated with traditional NSAIDs, potentially increasing the market share of safer alternatives[3].

Conclusion

NAPRELAN, with its proven efficacy in clinical trials and its position within the growing NSAIDs market, is poised for continued market presence. The preference for NSAIDs over opioids, the increasing prevalence of chronic pain, and the aging population are key drivers of this growth. However, the market must navigate challenges such as regulatory policies and the need for safer drug formulations.

Key Takeaways

• Clinical Efficacy: NAPRELAN is effective in managing rheumatoid arthritis, osteoarthritis, and acute pain.
• Market Growth: The global naproxen market is expected to grow at a CAGR of 5.5% until 2034.
• Regional Dominance: North America is a significant market for NSAIDs, including naproxen.
• Future Drivers: Increasing chronic pain prevalence, preference over opioids, and an aging population will drive market growth.
• Challenges: Stringent regulatory policies and the need for safer drug formulations are key challenges.

FAQs

Q: What is the primary use of NAPRELAN?

A: NAPRELAN is primarily used for the management of pain, inflammation, and various arthritic conditions such as rheumatoid arthritis and osteoarthritis.

Q: What are the common adverse reactions associated with NAPRELAN?

A: Common adverse reactions include headache, dyspepsia, flu syndrome, dizziness, nausea, and abdominal pain.

Q: How does the global market for naproxen project to grow?

A: The global naproxen market is anticipated to grow at a CAGR of 5.5% until 2034, reaching significant volumes.

Q: Which region is a prominent consumer of naproxen?

A: North America is one of the prominent consumers of naproxen globally.

Q: What are the key drivers of the NSAIDs market growth?

A: The preference for NSAIDs over opioids, increasing prevalence of chronic pain, and an aging population are key drivers of the market growth.

Sources:

1. RxList - Naprelan (Naproxen Sodium): Side Effects, Uses, Dosage ...
2. ChemAnalyst - Naproxen Market Size, Share, Growth and Forecast to 2034
3. Fortune Business Insights - Non-steroidal Anti-Inflammatory Drugs [NSAIDs] Market Size By 2032
4. CenterWatch - Naprelan (naproxen sodium)
5. GlobeNewswire - COX-2 Selective NSAIDs Market Research Report 2025-2030