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Last Updated: January 3, 2025

CLINICAL TRIALS PROFILE FOR NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE


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All Clinical Trials for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00382993 ↗ A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 2 of 2) Completed GlaxoSmithKline Phase 3 2006-12-01 This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). [Study 2 of 2]
NCT00383162 ↗ A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 1 of 2) Completed GlaxoSmithKline Phase 3 2006-11-01 This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). [Study 1 of 2]
NCT00387881 ↗ TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1) Completed GlaxoSmithKline Phase 3 2006-09-01 This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.
NCT00329355 ↗ Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA) Completed GlaxoSmithKline Phase 3 2006-05-01 This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.
NCT00329459 ↗ Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea Completed GlaxoSmithKline Phase 3 2006-05-01 This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.
NCT00434083 ↗ To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migrane Headaches Completed POZEN Phase 3 2004-07-01 - to demonstrate the superiority of Trexima (combination of sumatriptan as the succinate 85 mg and naproxen sodium 500 mg) versus placebo in the acute treatment of migraine - to demonstrate the superiority of Trexima versus the individual components (sumatriptan as the succinate 85 mg and naproxen sodium 500 mg), and - to evaluate the safety of the Trexima.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Condition Name

7221001234567Migraine DisordersMigraineMigraine With or Without AuraMigraine Headaches[disabled in preview]
Condition Name for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Intervention Trials
Migraine Disorders 7
Migraine 2
Migraine With or Without Aura 2
Migraine Headaches 1
[disabled in preview] 0
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Condition MeSH

112110-10123456789101112Migraine DisordersPremenstrual SyndromeHeadacheDysmenorrhea[disabled in preview]
Condition MeSH for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Intervention Trials
Migraine Disorders 11
Premenstrual Syndrome 2
Headache 1
Dysmenorrhea 1
[disabled in preview] 0
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Clinical Trial Locations for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Trials by Country

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Trials by Country for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Location Trials
United States 142
China 1
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Trials by US State

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Trials by US State for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Location Trials
Tennessee 7
Missouri 6
Washington 6
Texas 6
Ohio 6
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Clinical Trial Progress for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Clinical Trial Phase

9.1%72.7%18.2%0012345678Phase 4Phase 3Phase 1[disabled in preview]
Clinical Trial Phase for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Clinical Trial Phase Trials
Phase 4 1
Phase 3 8
Phase 1 2
[disabled in preview] 0
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Clinical Trial Status

90.9%9.1%0-101234567891011CompletedRecruiting[disabled in preview]
Clinical Trial Status for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Clinical Trial Phase Trials
Completed 10
Recruiting 1
[disabled in preview] 0
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Clinical Trial Sponsors for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Sponsor Name

trials0123456789GlaxoSmithKlineSecond Affiliated Hospital of Wenzhou Medical UniversitySecond Hospital of Jilin University[disabled in preview]
Sponsor Name for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Sponsor Trials
GlaxoSmithKline 9
Second Affiliated Hospital of Wenzhou Medical University 1
Second Hospital of Jilin University 1
[disabled in preview] 3
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Sponsor Type

54.5%45.5%0024681012OtherIndustry[disabled in preview]
Sponsor Type for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Sponsor Trials
Other 12
Industry 10
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NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE Market Analysis and Financial Projection

Naproxen Sodium and Sumatriptan Succinate: Clinical Trials, Market Analysis, and Projections

Introduction

Naproxen sodium and sumatriptan succinate are two medications that have been extensively studied and used for various medical conditions, particularly pain management and migraine treatment. This article delves into the recent clinical trials, market analysis, and future projections for these drugs.

Clinical Trials: Naproxen Sodium

Efficacy in Pain Management

Naproxen sodium has been shown to be highly effective in reducing post-operative pain and systemic inflammation. A randomized, double-blind pilot study indicated that naproxen sodium was more effective than acetaminophen in these areas following surgical procedures[1].

Mechanism of Action

Naproxen sodium inhibits both COX-1 and COX-2 activity, which is crucial for its anti-inflammatory and analgesic effects. The study found that naproxen sodium inhibited COX-1 activity by more than 90% and tended to inhibit COX-2 activity to a greater degree than acetaminophen, although the difference in COX-2 inhibition was not statistically significant[1].

Clinical Trials: Sumatriptan Succinate

Efficacy in Migraine Treatment

Sumatriptan succinate has been proven to be highly effective in treating migraines. A randomized, double-blind, placebo-controlled clinical trial demonstrated that sumatriptan succinate injection significantly reduced productivity loss during migraine attacks in the workplace. The study showed that patients treated with sumatriptan succinate returned to normal work performance more quickly and had less headache recurrence compared to those receiving a placebo[2].

Combination Therapy with Naproxen Sodium

The combination of sumatriptan and naproxen sodium has been particularly effective in treating migraines. A review of 14 clinical trials found that this combination offered greater efficacy for 2-hour pain freedom and sustained pain-free responses up to 24 hours compared to monotherapy or placebo. This combination is beneficial for patients with various types of migraines, including those with allodynia and menstrual-related migraines[4].

Market Analysis: Naproxen Sodium

Current Market Status

Naproxen sodium, commonly known by the brand name Aleve, is widely used for its anti-inflammatory and analgesic properties. The market for naproxen sodium is stable, with a strong presence in the over-the-counter (OTC) pain relief segment. However, the market is somewhat saturated, and growth is largely driven by brand loyalty and new formulations rather than significant increases in market size.

Emerging Trends

There is a growing interest in combination therapies, such as the pairing of naproxen sodium with other medications like diphenhydramine hydrochloride, which is being studied for its potential in treating sleep initiation and maintenance disorders[5].

Market Analysis: Sumatriptan Succinate

Current Market Status

The sumatriptan succinate market is experiencing significant growth driven by the increasing prevalence of migraines globally. Over a billion people worldwide suffer from migraines, creating a large and growing market for effective treatments like sumatriptan succinate[3].

Future Projections

The sumatriptan succinate market is anticipated to witness a compound annual growth rate (CAGR) of a notable percentage from 2024 to 2031. This growth is fueled by increasing awareness about migraine management, the availability of both branded and generic formulations, and the rise in demand for non-invasive treatments such as nasal sprays or subcutaneous injections. Emerging markets in Asia-Pacific, Latin America, and Africa also present considerable growth opportunities due to improving healthcare access and expanding insurance coverage[3].

Innovations and Advancements

Advanced Drug Delivery Systems

Companies in the market are focusing on innovations such as quicker onset formulations and longer-lasting effects to capture a larger market share. The introduction of advanced drug delivery systems, such as nasal sprays and subcutaneous injections, is expected to further fuel demand for sumatriptan succinate[3].

Patient-Centric Product Offerings

There is a growing emphasis on developing product offerings tailored to patient preferences. This includes a broader range of formulations and delivery methods that cater to different patient needs, enhancing the overall treatment experience and adherence[3].

Key Takeaways

  • Naproxen Sodium: Highly effective in reducing post-operative pain and systemic inflammation, with a strong mechanism of action through COX-1 and COX-2 inhibition.
  • Sumatriptan Succinate: Proven to significantly reduce productivity loss during migraine attacks and is highly effective in combination with naproxen sodium for treating migraines.
  • Market Growth: The sumatriptan succinate market is expected to grow significantly due to increasing prevalence of migraines and advancements in drug delivery systems.
  • Innovations: Companies are focusing on quicker onset formulations, longer-lasting effects, and patient-centric product offerings to drive market growth.

FAQs

Q: What is the primary mechanism of action of naproxen sodium?

A: Naproxen sodium primarily works by inhibiting both COX-1 and COX-2 activity, which reduces inflammation and pain.

Q: How effective is sumatriptan succinate in treating migraines?

A: Sumatriptan succinate is highly effective in treating migraines, significantly reducing productivity loss and headache recurrence compared to placebo.

Q: What are the key drivers of the sumatriptan succinate market growth?

A: The key drivers include the increasing prevalence of migraines, growing awareness about migraine management, and advancements in drug delivery systems.

Q: Are there any emerging trends in the naproxen sodium market?

A: Yes, there is a growing interest in combination therapies, such as pairing naproxen sodium with other medications for different indications.

Q: What regions present significant growth opportunities for the sumatriptan succinate market?

A: Emerging markets in Asia-Pacific, Latin America, and Africa present considerable growth opportunities due to improving healthcare access and expanding insurance coverage.

Sources

  1. Frontiers in Pharmacology: "A randomized, double-blind pilot study of analgesic and anti-inflammatory effects of naproxen sodium versus acetaminophen following surgical placement of one or two dental implants."
  2. JAMA Internal Medicine: "Sumatriptan Injection Reduces Productivity Loss During a Migraine Attack in the Workplace."
  3. OpenPR: "Sumatriptan Succinate Market Current Status and Future."
  4. PubMed: "Sumatriptan-naproxen sodium in migraine: A review."
  5. Synapse: "Diphenhydramine Hydrochloride/Naproxen Sodium - Drug Targets and Clinical Trials."

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