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Last Updated: November 24, 2020

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CLINICAL TRIALS PROFILE FOR DICLOFENAC

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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 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 2002-06-01 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.
NCT00121901 Does Glyceryl Nitrate Prevent Post-Endoscopic Retrograde Cholangiopancreaticography (ERCP) Pancreatitis? Completed Hvidovre University Hospital Phase 3 2004-10-01 Post-ERCP pancreatitis can be a serious complication to ERCP. Two studies have shown a promising preventive effect of glyceryl nitrate. This study should provide a final answer to the clinical question: Does glyceryl nitrate prevent post-ERCP pancreatitis? The study is a prospective, randomized, double blind, placebo-controlled multicenter trial. The investigators intend to include 1600 patients from Norway, Sweden, Denmark, and France. The patients will receive either placebo or a glyceryl nitrate patch (15 mg/24 hours). Follow-up will occur after 7 days. The primary outcome measure will be post-ERCP pancreatitis, and secondary outcome measures will be mild, moderate and severe pancreatitis; post procedure pancreatitis-related mortality; and adverse events.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Diclofenac

Condition Name

Condition Name for Diclofenac
Intervention Trials
Pain 48
Osteoarthritis 22
Postoperative Pain 14
Pain, Postoperative 12
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Condition MeSH

Condition MeSH for Diclofenac
Intervention Trials
Osteoarthritis 52
Pain, Postoperative 40
Osteoarthritis, Knee 33
Sprains and Strains 14
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Clinical Trial Locations for Diclofenac

Trials by Country

Trials by Country for Diclofenac
Location Trials
United States 404
United Kingdom 60
Germany 34
India 30
Egypt 29
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Trials by US State

Trials by US State for Diclofenac
Location Trials
Texas 31
Florida 27
California 24
Pennsylvania 20
Alabama 17
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Clinical Trial Progress for Diclofenac

Clinical Trial Phase

Clinical Trial Phase for Diclofenac
Clinical Trial Phase Trials
Phase 4 105
Phase 3 91
Phase 2/Phase 3 12
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Clinical Trial Status

Clinical Trial Status for Diclofenac
Clinical Trial Phase Trials
Completed 198
Recruiting 69
Not yet recruiting 32
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Clinical Trial Sponsors for Diclofenac

Sponsor Name

Sponsor Name for Diclofenac
Sponsor Trials
Novartis 18
Merck Sharp & Dohme Corp. 13
Cairo University 12
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Sponsor Type

Sponsor Type for Diclofenac
Sponsor Trials
Other 281
Industry 166
U.S. Fed 5
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