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

Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR DICLOFENAC


✉ Email this page to a colleague

« Back to Dashboard


505(b)(2) Clinical Trials for Diclofenac

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 NCT02068859 ↗ Treatment of Knee Pain With Topical Diclofenac Cream 8% or Diclofenac Gel 1% Unknown status FPR Specialty Pharmacy Phase 3 2014-01-01 Non-steroidal anti-inflammatory medication (NSAID) therapy is a mainstay treatment for joint pain and painful musculoskeletal disorders. Though this form of systemic therapy is highly effective, it causes substantial side effects including gastritis and gastric ulcer disease, renal impairment, hypertension, and thrombotic events. These types of oral medications are utilized by millions of Americans on a fairly regular basis in both over-the-counter preparations and prescription compounds. In recent years, topical preparations of NSAIDs have been used for localized pain as an alternate to oral administration with reported good analgesic efficacy. For example, they are often used for knee pain. There is little systemic absorption of NSAIDs with topical administration, and consequently less likelihood of systemic side effects. Though much less studied than oral NSAIDs, topical NSAID preparations are currently prescribed for a variety of arthritic and musculoskeletal types of pain. The best-studied commercially available products are diclofenac 1% compounds. Higher concentrations presumably provide higher tissue concentration leading to better and longer pain relief, along with a more prominent anti-inflammatory effect. The investigators will therefore compare the efficacy of available topical diclofenac 1% gel to that of diclofenac 8% cream. Specifically, the investigators propose to test the hypothesis that efficacy of topical diclofenac 8% exceeds that of diclofenac 1%, without any increase in systemic toxicity. One hundred six patients presenting to the Cleveland Clinic Pain Management Department for the treatment of knee pain will be randomly assigned to topical diclofenac cream 8% or diclofenac gel 1%, with the designated medication applied the symptomatic area of the knee over 6 weeks. Investigators will be blinded to treatment, and will evaluate pain relief and functional/disability status.
New Formulation NCT03766984 ↗ Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac Completed Grünenthal Colombiana S.A. Phase 1 2015-06-07 The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combination of diclofenac 25 milligrams (mg) and tramadol 25 mg for oral administration. The study was conducted in healthy participants of both genders.
New Formulation NCT03766984 ↗ Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac Completed Grünenthal S.A. Phase 1 2015-06-07 The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combination of diclofenac 25 milligrams (mg) and tramadol 25 mg for oral administration. The study was conducted in healthy participants of both genders.
New Formulation NCT03766984 ↗ Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac Completed Grünenthal GmbH Phase 1 2015-06-07 The objective of the study was to evaluate whether or not there is a substantial pharmacokinetic interaction between diclofenac and tramadol in a new formulation of a fixed-dose combination of diclofenac 25 milligrams (mg) and tramadol 25 mg for oral administration. The study was conducted in healthy participants of both genders.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Diclofenac

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00090181 ↗ Study of MK0663 in Patients With Chronic Low Back Pain (0663-806)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 4 2004-06-01 The purpose of this study is to evaluate the efficacy of MK0663 for the treatment of chronic low back pain and to investigate the overall safety and tolerability over four weeks of treatment.
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.
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.
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.
NCT00108992 ↗ Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis Completed Nuvo Research Inc. Phase 3 2004-02-01 Oral non-steroidal anti-inflammatory drugs (NSAIDs) are a recommended treatment for the symptoms of osteoarthritis of the knee. However, NSAIDs may cause a range of negative side effects, including stomach pain, heartburn, bleeding stomach ulcer, and liver or kidney abnormality. A topical NSAID may relieve pain and other symptoms of osteoarthritis of the knee, while minimizing the side effects common to oral NSAIDs. The purpose of this study is to determine the safety and effectiveness of a topical NSAID when used alone or when combined with an oral NSAID in the treatment of osteoarthritis of the knee.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Diclofenac

Condition Name

Condition Name for Diclofenac
Intervention Trials
Pain 51
Osteoarthritis 23
Postoperative Pain 17
Pain, Postoperative 16
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Diclofenac
Intervention Trials
Osteoarthritis 57
Pain, Postoperative 56
Osteoarthritis, Knee 36
Sprains and Strains 15
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Diclofenac

Trials by Country

Trials by Country for Diclofenac
Location Trials
United States 446
United Kingdom 68
India 42
Germany 38
Egypt 36
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
Location Trials
Texas 33
Florida 29
California 26
Pennsylvania 21
Alabama 19
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Diclofenac

Clinical Trial Phase

Clinical Trial Phase for Diclofenac
Clinical Trial Phase Trials
Phase 4 127
Phase 3 98
Phase 2/Phase 3 12
[disabled in preview] 54
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Diclofenac
Clinical Trial Phase Trials
Completed 272
Unknown status 45
Recruiting 44
[disabled in preview] 53
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Diclofenac

Sponsor Name

Sponsor Name for Diclofenac
Sponsor Trials
Cairo University 20
Novartis 18
Pfizer 14
[disabled in preview] 23
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Diclofenac
Sponsor Trials
Other 352
Industry 194
U.S. Fed 7
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Diclofenac: Clinical Trials, Market Analysis, and Projections

Introduction to Diclofenac

Diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), is widely used for its analgesic, anti-inflammatory, and antipyretic properties. It is available in various formulations, including oral tablets, topical gels, patches, and solutions. Here, we will delve into the recent clinical trials, market analysis, and future projections for diclofenac.

Clinical Trials Update

Efficacy and Safety of Diclofenac Sodium 2% Topical Solution

A significant clinical trial focused on the efficacy and safety of diclofenac sodium 2% topical solution for osteoarthritis (OA) of the knee. This study, conducted over four weeks, involved 260 patients randomized into two treatment groups: diclofenac sodium 2% topical solution and a vehicle control. The results showed that the diclofenac sodium 2% topical solution resulted in significantly greater improvement in pain reduction compared to the vehicle control. The mean changes from baseline in WOMAC pain scores were approximately -6.0 for the diclofenac group, compared to -4.7 for the vehicle control group[1].

Safety and Tolerability

The study also assessed treatment-emergent adverse events (TEAEs) and vital signs throughout the four-week period. Additional laboratory tests were performed at screening and the final visit. The results indicated that the diclofenac sodium 2% topical solution was well-tolerated, with most TEAEs being grade 1-2. Only one patient discontinued treatment due to a TEAE[1].

Other Clinical Trials

Diclofenac has been studied in various other clinical trials for different indications, including myalgia, contusions, soft tissue injuries, ankle injuries, and sunburn. These trials have generally shown positive results, with diclofenac demonstrating efficacy in managing pain and inflammation. For example, a Phase 3 study on diclofenac sodium gel for osteoarthritis showed significant pain reduction and improvement in functional outcomes[4].

Market Analysis

Current Market Size and Growth

The global diclofenac market has been experiencing steady growth driven by several key factors. As of 2022, the diclofenac market size was valued at USD 5.8 billion and is projected to reach USD 8.1 billion by 2030, growing at a CAGR of 4.5% from 2024 to 2030[5].

Key Drivers

The increasing prevalence of chronic pain, osteoarthritis, and rheumatoid arthritis is a major driver of the diclofenac market. The growing geriatric population and rising awareness about the benefits of NSAIDs also contribute to the market's growth. Additionally, the development of innovative formulations such as topical gels and patches is expanding the reach of diclofenac products[5].

Market Trends

The market is expected to witness significant growth due to the high prevalence of chronic pain diseases. According to the American Academy of Pain Medicine, around 1.8 billion people suffered from chronic pain in 2011, and this number is expected to rise. The increasing prevalence of diseases such as cancer, which often involves chronic pain, is also driving the demand for diclofenac-based treatments[3].

Regional and Global Outlook

The diclofenac market is expected to expand globally, with emerging economies playing a significant role. Rising disposable incomes and urbanization in these regions are anticipated to drive a shift in the sales ratio toward these markets. Sustainability trends and legislative backing are also expected to make the diclofenac market a priority for investors and industry participants[5].

Market Projections

Forecasted Growth

The diclofenac market is projected to exhibit a healthy CAGR during the forecast period from 2025 to 2033. The market size is expected to expand significantly, driven by the rising demand for NSAIDs and the growing awareness of the benefits of diclofenac in treating various conditions such as osteoarthritis, rheumatoid arthritis, and sprains[2].

Future Scope and Trends

The future of the diclofenac market appears promising, with market expansion fueled by rising consumer demand, developing technologies, and growing applications. The development of new formulations and delivery methods, such as patches and topical gels, is expected to further increase the market's reach. Sustainability trends and legislative support are also anticipated to play a crucial role in the market's growth[5].

Key Takeaways

  • Clinical Efficacy: Diclofenac sodium 2% topical solution has shown significant efficacy in reducing pain in patients with osteoarthritis of the knee.
  • Safety Profile: Diclofenac is generally well-tolerated, with most adverse events being mild.
  • Market Growth: The global diclofenac market is projected to grow at a CAGR of 4.5% from 2024 to 2030.
  • Key Drivers: Increasing prevalence of chronic pain, growing geriatric population, and innovative formulations are driving the market.
  • Future Outlook: The market is expected to expand globally, driven by rising consumer demand and technological advancements.

FAQs

What are the common indications for diclofenac?

Diclofenac is commonly used to treat conditions such as osteoarthritis, rheumatoid arthritis, sprains, and various types of pain and inflammation.

What are the different formulations of diclofenac available?

Diclofenac is available in various formulations, including oral tablets, topical gels, patches, and solutions.

What is the projected market size of diclofenac by 2030?

The diclofenac market is projected to reach USD 8.1 billion by 2030, growing at a CAGR of 4.5% from 2024 to 2030.

What are the key drivers of the diclofenac market?

The key drivers include the increasing prevalence of chronic pain, growing geriatric population, and the development of innovative formulations.

Is diclofenac safe for long-term use?

Diclofenac is generally well-tolerated, but long-term use should be monitored due to potential side effects associated with NSAIDs, such as gastrointestinal issues and cardiovascular risks.

Sources

  1. Efficacy and safety of diclofenac sodium 2% topical solution for osteoarthritis of the knee. Tandfonline.
  2. Diclofenac Potassium's Role in Shaping Industry Trends 2025-2033. Data Insights Market.
  3. Diclofenac Patches Market Size, Trends And Forecast To 2028. Coherent Market Insights.
  4. Diclofenac Sodium - Drug Targets, Indications, Patents. Synapse.
  5. Diclofenac Market Key Drivers and Forecast 2025-2032. GitHub.

More… ↓

⤷  Free Trial

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.