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Last Updated: April 30, 2025

CLINICAL TRIALS PROFILE FOR ANAPROX DS


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All Clinical Trials for Anaprox Ds

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00688961 ↗ Effects of Omacor and Aspirin on Platelet Function Completed Sanford Research Early Phase 1 2007-06-01 Omacor (now Lovaza) is a pharmaceutical omega-3 fatty acid product. Omega-3 fatty acids can affect blood clotting by altering the function of the blood platelets. Aspirin can do the same. The purpose of this study is to determine the individual and combined effects of these two agents on platelet function using a whole blood method.
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.
NCT01052129 ↗ Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fasting Condition Completed Dr. Reddy's Laboratories Limited Phase 1 2006-05-01 An open label randomised, two-treatment, two-period, two-sequence, single-dose, crossover, comparative bioequivalence study.
NCT01052792 ↗ Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fed Conditions Completed Dr. Reddy's Laboratories Limited Phase 1 2006-05-01 An open label randomised, two-treatment,two-period, two-sequence, single-dose, crossover, comparative bioequivalence study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Anaprox Ds

Condition Name

Condition Name for Anaprox Ds
Intervention Trials
Healthy 3
Chronic Low Back Pain 2
Acute Pain 2
Opioid Dependence 1
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Condition MeSH

Condition MeSH for Anaprox Ds
Intervention Trials
Back Pain 4
Low Back Pain 3
Acute Pain 2
Syndrome 1
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Clinical Trial Locations for Anaprox Ds

Trials by Country

Trials by Country for Anaprox Ds
Location Trials
United States 7
India 2
Thailand 1
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Trials by US State

Trials by US State for Anaprox Ds
Location Trials
Illinois 5
New York 1
South Dakota 1
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Clinical Trial Progress for Anaprox Ds

Clinical Trial Phase

Clinical Trial Phase for Anaprox Ds
Clinical Trial Phase Trials
Phase 4 5
Phase 2/Phase 3 1
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Anaprox Ds
Clinical Trial Phase Trials
Completed 6
Withdrawn 3
Unknown status 2
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Clinical Trial Sponsors for Anaprox Ds

Sponsor Name

Sponsor Name for Anaprox Ds
Sponsor Trials
National Institutes of Health (NIH) 6
Northwestern University 5
Dr. Reddy's Laboratories Limited 2
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Sponsor Type

Sponsor Type for Anaprox Ds
Sponsor Trials
Other 14
NIH 10
Industry 5
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Anaprox DS: Clinical Trials, Market Analysis, and Projections

Introduction to Anaprox DS

Anaprox DS, a formulation of naproxen sodium, is a nonsteroidal anti-inflammatory drug (NSAID) widely used for its anti-inflammatory, analgesic, and antipyretic properties. It is commonly prescribed for various painful conditions, including arthritis, menstrual cramps, and musculoskeletal trauma.

Clinical Trials and Efficacy

Pain Relief and Intrauterine Pressure

In a significant clinical trial, 24 women with dysmenorrhea were administered either a single dose of Anaprox DS (1100 mg) or a placebo. The results showed that all 11 patients given Anaprox DS experienced complete pain relief within 2 hours, while only 3 of the 13 patients given the placebo achieved similar relief. This trial also measured intrauterine pressure (IUP) and found a significant decrease in IUP in the Anaprox DS group, from a mean of 51.4 mm Hg to 26.8 mm Hg, compared to minimal changes in the placebo group. This reduction in IUP was directly linked to the pain-relieving effects of Anaprox DS[1].

Other Clinical Uses

Anaprox DS is indicated for the relief of mild to moderately severe pain accompanied by inflammation in conditions such as musculoskeletal trauma, post-dental extraction, post-partum cramping, and dysmenorrhea. Clinical trials and postmarket experience have established its efficacy in these areas, although it is crucial to use the lowest effective dose for the shortest possible duration to minimize potential risks[4].

Market Analysis

Market Drivers

The naproxen market, including Anaprox DS, is driven by several key factors:

  • Availability as a Non-Prescription Drug: Naproxen's availability over-the-counter (OTC) significantly boosts its market. This ease of access makes it a preferred choice for many consumers[2].
  • Established Benefits and Risks: The well-documented benefits and risks of naproxen contribute to its widespread use and acceptance[2].
  • Growing Geriatric Population: The increasing number of older adults, who are more likely to suffer from arthritis and other chronic conditions, propels the demand for naproxen[2].
  • Pharmaceutical Industry Growth: The expansion of pharmaceutical industries, especially in developing nations, creates new opportunities for the naproxen market[5].

Market Segmentation

The naproxen market, including Anaprox DS, is segmented based on several criteria:

  • Disease Indication: The market is segmented into various indications such as osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, juvenile arthritis, bursitis, menstrual cramps, gout, and tendonitis[2][5].
  • Formulation: The market includes oral tablets and liquid suspension formulations[2][5].
  • Distribution Channel: The market is segmented into hospital pharmacies, retail pharmacies, drug stores, and e-commerce platforms[2][5].

Regional Analysis

The naproxen market is analyzed across several regions, including North America, Europe, Asia-Pacific (APAC), Middle East & Africa (MEA), and Latin America. Each region is further sub-segmented by country, providing a detailed overview of the market dynamics and growth opportunities[5].

Market Projections

Growth Forecast

The naproxen market, including Anaprox DS, is expected to witness significant growth during the forecast period from 2024 to 2031. This growth is anticipated due to the increasing prevalence of arthritis and other chronic conditions, as well as the expanding pharmaceutical industry in developing nations. The market is predicted to record a substantial Compound Annual Growth Rate (CAGR) during this period[5].

Market Size and Value

As of 2023, the naproxen market size is valued at several million dollars, with projections indicating a substantial increase by 2031. The detailed market size and value forecasts are provided in comprehensive market reports, which also include historical data and future projections[5].

Challenges and Considerations

Safety and Risks

While Anaprox DS is effective, it comes with several safety considerations:

  • Cardiovascular Risks: Use of naproxen may increase the risk of cardiovascular events such as heart attacks and strokes, especially in older populations[4].
  • Gastrointestinal Risks: There is a risk of upper GI ulcers, gross bleeding, or perforation, particularly in patients with a history of peptic or duodenal ulcer disease[4].
  • Contraindications: Anaprox DS is contraindicated in certain conditions, including the peri-operative setting of coronary artery bypass graft surgery, the third trimester of pregnancy, and in women who are breastfeeding[4].

Monitoring and Precautions

To minimize risks, patients on Anaprox DS should be monitored for serum creatinine, creatine clearance, and serum urea. Electrolytes, including serum potassium, should also be periodically checked. Additionally, therapy with Anaprox DS should be temporarily discontinued 48 hours before adrenal function tests are performed to avoid interference with certain assays[4].

Key Takeaways

  • Efficacy in Pain Relief: Anaprox DS has been shown to be highly effective in reducing pain and intrauterine pressure in clinical trials.
  • Market Drivers: The market is driven by its OTC availability, established benefits and risks, growing geriatric population, and expanding pharmaceutical industry.
  • Segmentation: The market is segmented by disease indication, formulation, and distribution channel.
  • Growth Projections: The naproxen market is expected to grow significantly from 2024 to 2031.
  • Safety Considerations: Use of Anaprox DS requires careful monitoring and adherence to contraindications to minimize cardiovascular and gastrointestinal risks.

FAQs

What are the primary indications for Anaprox DS?

Anaprox DS is indicated for the relief of mild to moderately severe pain accompanied by inflammation in conditions such as musculoskeletal trauma, post-dental extraction, post-partum cramping, and dysmenorrhea[4].

What are the key drivers of the naproxen market?

The key drivers include its availability as a non-prescription drug, well-established benefits and risks, growing geriatric population, and the expansion of pharmaceutical industries in developing nations[2][5].

What are the potential risks associated with Anaprox DS?

Potential risks include cardiovascular events, gastrointestinal ulcers, bleeding, or perforation, especially in older populations and those with a history of peptic or duodenal ulcer disease[4].

How is the naproxen market segmented?

The market is segmented by disease indication (e.g., OA, RA, menstrual cramps), formulation (oral tablets, liquid suspension), and distribution channel (hospital pharmacies, retail pharmacies, drug stores, e-commerce)[2][5].

What is the projected growth of the naproxen market?

The naproxen market is expected to record a significant CAGR from 2024 to 2031, driven by increasing prevalence of arthritis and other chronic conditions, and the growing pharmaceutical industry in developing nations[5].

Sources

  1. Anaprox in dysmenorrhea: reduction of pain and intrauterine pressure - PubMed
  2. Naproxen Market Insight and Trends 2024 - Transparency Market Research
  3. Naprosyn - accessdata.fda.gov - FDA
  4. Anaprox - Health Canada
  5. Naproxen Market SWOT Analysis by 2031 - The Insight Partners

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