You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: April 26, 2025

CLINICAL TRIALS PROFILE FOR DICLOFENAC SODIUM


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for diclofenac sodium

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00140972 ↗ A Study to Assess Etoricoxib Versus Diclofenac in Chinese Patients With Osteoarthritis of the Knee or Hip (0663-080)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 4 2004-12-03 A Study to Assess Etoricoxib versus Diclofenac in Chinese Patients with Osteoarthritis of the Knee or Hip
NCT00092378 ↗ A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2003-09-01 This purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following bunionectomy surgery.
NCT00092742 ↗ Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072) Completed Merck Sharp & Dohme Corp. Phase 3 2003-02-01 The purpose of this study is to evaluate the long-term safety of an investigational drug versus an approved drug for the relief of pain in patients with rheumatoid arthritis.
NCT00092703 ↗ Investigational Drug Versus an Approved Drug in Patients With Osteoarthritis (0663-061)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2002-06-27 The purpose of this study is to compare the gastrointestinal tolerability of an investigational drug to an approved drug in the treatment of osteoarthritis during one year treatment period.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for diclofenac sodium

Condition Name

141176002468101214PainOsteoarthritisHealthyPostoperative Pain[disabled in preview]
Condition Name for diclofenac sodium
Intervention Trials
Pain 14
Osteoarthritis 11
Healthy 7
Postoperative Pain 6
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

22151170-2024681012141618202224OsteoarthritisOsteoarthritis, KneePain, PostoperativeKeratosis[disabled in preview]
Condition MeSH for diclofenac sodium
Intervention Trials
Osteoarthritis 22
Osteoarthritis, Knee 15
Pain, Postoperative 11
Keratosis 7
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for diclofenac sodium

Trials by Country

+
Trials by Country for diclofenac sodium
Location Trials
United States 204
India 32
Egypt 13
Brazil 13
China 12
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

+
Trials by US State for diclofenac sodium
Location Trials
Florida 16
Texas 14
California 11
Pennsylvania 9
Ohio 9
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for diclofenac sodium

Clinical Trial Phase

36.4%42.4%17.2%051015202530354045Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for diclofenac sodium
Clinical Trial Phase Trials
Phase 4 36
Phase 3 42
Phase 2/Phase 3 4
[disabled in preview] 17
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

69.7%13.4%9.9%7.0%0102030405060708090100CompletedUnknown statusRecruiting[disabled in preview]
Clinical Trial Status for diclofenac sodium
Clinical Trial Phase Trials
Completed 99
Unknown status 19
Recruiting 14
[disabled in preview] 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for diclofenac sodium

Sponsor Name

trials012345678910111213NovartisMerck Sharp & Dohme Corp.PPD[disabled in preview]
Sponsor Name for diclofenac sodium
Sponsor Trials
Novartis 12
Merck Sharp & Dohme Corp. 6
PPD 5
[disabled in preview] 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

53.0%45.9%00102030405060708090100OtherIndustryNIH[disabled in preview]
Sponsor Type for diclofenac sodium
Sponsor Trials
Other 97
Industry 84
NIH 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Diclofenac Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Diclofenac sodium, a widely used non-steroidal anti-inflammatory drug (NSAID), has been a cornerstone in the management of various inflammatory and pain-related conditions. This article delves into the recent clinical trials, market analysis, and future projections for diclofenac sodium, highlighting its efficacy, market trends, and potential challenges.

Clinical Trials Update

Efficacy in Hand Osteoarthritis

Recent clinical trials have demonstrated the efficacy of diclofenac sodium gel in treating hand osteoarthritis. A randomized, double-blind, placebo-controlled trial showed that diclofenac sodium gel 1% provided significant symptomatic relief compared to the vehicle group. The trial, which included 198 diclofenac-treated and 187 vehicle-treated patients, revealed clinically meaningful improvements in pain intensity, AUSCAN total, pain, function, and stiffness as early as Week 1 and sustained through Weeks 4 and 6[1].

Topical Diclofenac Solution for Knee Osteoarthritis

A 12-week trial comparing topical diclofenac solution (Pennsaid) with a vehicle-control solution in patients with knee osteoarthritis found that the topical diclofenac solution was significantly more effective in reducing pain, improving physical function, and patient global assessment. The study also noted minor skin irritation as a common adverse effect but no significant difference in NSAID-related gastrointestinal complaints[4].

Market Analysis

Global Market Size and Growth

The global diclofenac market is projected to experience substantial growth over the next decade. By 2033, the market is expected to grow from USD 4.2 billion in 2023 to USD 6.4 billion, with a compound annual growth rate (CAGR) of 4.3%[2].

Similarly, the diclofenac sodium market is anticipated to grow from USD 2.5 billion in 2024 to USD 3.7 billion by 2031, at a CAGR of 4.5%[3].

Market Segmentation

By Type

The market is segmented into tablets and injections, with tablets holding the major share due to their widespread use and various formulations available for different patient needs[3].

By Application

The elderly population constitutes a significant segment, driven by their higher susceptibility to inflammatory and pain-related conditions. Adults also form a substantial part of the market, but the elderly segment is more prominent[3].

By Geography

North America currently dominates the diclofenac market, thanks to its robust medical infrastructure and high healthcare expenditure. However, the Asia-Pacific region is expected to offer lucrative growth opportunities due to increasing medical advertisements, government support for medical development, and a growing geriatric population[2][5].

By Distribution Channel

Retail pharmacies are the primary distribution channels, holding a significant market share of around 68.4%[2].

Key Drivers and Challenges

Drivers

  • The increasing incidence of chronic pain and arthritis, particularly among the geriatric population, is a major driver.
  • Advances in formulation and delivery methods aimed at reducing side effects are also boosting market growth[2][5].

Challenges

  • Potential side effects such as cardiovascular and gastrointestinal issues remain significant challenges.
  • The geriatric population must be cautious when using diclofenac for extended periods due to the risk of adverse events like thrombotic cardiovascular events and gastrointestinal complications[2][5].

Market Projections

Future Growth Opportunities

The diclofenac market is poised for growth driven by several factors:

  • Geriatric Population: The increasing number of elderly individuals globally, who are more prone to inflammatory and pain-related conditions, will continue to drive demand[5].
  • Sports Injuries: The use of diclofenac sprays and topical treatments for sports-related injuries is expected to rise, especially with the increase in sporting events and activities[5].
  • Medical Infrastructure: Regions with robust medical infrastructure, such as North America and parts of Asia-Pacific, will continue to support market growth[2][5].

Regional Outlook

  • North America: Expected to maintain its dominant position due to strong medical infrastructure and high healthcare expenditure.
  • Asia-Pacific: Anticipated to offer significant growth opportunities due to government support, increasing medical advertisements, and a growing geriatric population[2][5].

Safety and Efficacy Considerations

Safety Profile

While diclofenac sodium is effective, it is not without risks. Common adverse effects include gastrointestinal issues, cardiovascular events, and minor skin irritation with topical use. These side effects necessitate careful patient monitoring, especially in the geriatric population[1][4].

Efficacy in Various Indications

Diclofenac sodium is used to treat a range of conditions, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and various types of pain such as back pain, toothache, and migraine. Its efficacy in these indications has been well-documented in clinical trials[3][5].

Key Takeaways

  • Market Growth: The global diclofenac market is projected to grow from USD 4.2 billion in 2023 to USD 6.4 billion by 2033, with a CAGR of 4.3%.
  • Segmentation: Tablets dominate the market type segment, while the elderly population is the primary application segment.
  • Geography: North America leads, but Asia-Pacific is expected to offer significant growth opportunities.
  • Drivers: Increasing geriatric population and advances in formulation and delivery methods.
  • Challenges: Potential side effects such as cardiovascular and gastrointestinal issues.

FAQs

Q: What is the projected growth rate of the global diclofenac market?

The global diclofenac market is expected to grow at a CAGR of 4.3% from 2024 to 2033[2].

Q: Which segment dominates the diclofenac market by type?

Tablets dominate the diclofenac market by type, due to their widespread use and various formulations[3].

Q: What are the primary drivers of the diclofenac market?

The primary drivers include the increasing incidence of chronic pain and arthritis, particularly among the geriatric population, and advances in formulation and delivery methods[2][5].

Q: What are the common side effects associated with diclofenac sodium?

Common side effects include gastrointestinal issues, cardiovascular events, and minor skin irritation with topical use[1][4].

Q: Which region is expected to offer significant growth opportunities for the diclofenac market?

The Asia-Pacific region is expected to offer significant growth opportunities due to government support, increasing medical advertisements, and a growing geriatric population[2][5].

Sources

  1. Peniston, J. H., et al. "Clinically Meaningful Improvements in Hand Osteoarthritis Pain With Diclofenac Sodium Gel 1%." Journal of Rheumatology, vol. 36, no. 9, 2009, pp. 1991-1999.
  2. News Market. "Diclofenac Market Growth Accelerates Amid Increased Demand." News Market, 22 July 2024.
  3. Verified Market Research. "Diclofenac Sodium Market Size, Share, Trends & Forecast." Verified Market Research, 2024.
  4. JAMA Internal Medicine. "Efficacy and Safety of a Topical Diclofenac Solution (Pennsaid) in the Treatment of Knee Osteoarthritis." JAMA Internal Medicine, 2017.
  5. IndustryARC. "Diclofenac Market Size Report, 2022-2027." IndustryARC, 2022.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.