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Diclofenac

Generic Name
Diclofenac
Brand Names
Aleve Arthritis Pain, Arthrotec, Cambia, Cataflam, Flector, Licart, Lofena, Pennsaid, Previdolrx Analgesic Pak, Salonpas Pain Relieving Patch, Solaraze, Voltaren, Voltaren Emulgel, Xrylix, Zipsor, Zorvolex
Drug Type
Small Molecule
Chemical Formula
C14H11Cl2NO2
CAS Number
15307-86-5
Unique Ingredient Identifier
144O8QL0L1
Background

Diclofenac is a phenylacetic acid derivative and non-steroidal anti-inflammatory drug (NSAID). NSAIDs inhibit cyclooxygenase (COX)-1 and-2 which are the enzyme responsible for producing prostaglandins (PGs). PGs contribute to inflammation and pain signalling. Diclofenac, like other NSAIDs, is often used as first line therapy for acute and chronic pain and inflammation from a variety of causes. Diclofenac was the product of rational drug design based on the structures of phenylbutazone, mefenamic acid, and indomethacin. The addition of two chlorine groups in the ortho position of the phenyl ring locks the ring in maximal torsion which appears to be related to increased potency. It is often used in combination with misoprostol to prevent NSAID-induced gastric ulcers. Diclofenac was first approved by the FDA in July 1988 under the trade name Voltaren, marketed by Novartis (previously Ciba-Geigy).

Indication

Diclofenac is indicated for use in the treatment of pain and inflammation from varying sources including inflammatory conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, as well as injury-related inflammation due to surgery and physical trauma. It is often used in combination with misoprostol as a gastro-protective agent in patients with high risk of developing NSAID-induced ulcers.

Associated Conditions
Actinic Keratosis (AK), Acute Arthritis, Acute Gouty Arthritis, Acute Migraine, Acute Musculoskeletal Pain, Ankylosing Spondylitis (AS), Common Cold, Fever, Gout, Inflammation, Inflammatory Disease of the Oral Cavity, Inflammatory Disease of the throat, Inflammatory Reaction of the Nerve, Joint Pain, Juvenile Idiopathic Arthritis (JIA), Menstrual Distress (Dysmenorrhea), Muscle Inflammation, Myalgia, Neuropathic Pain, Ocular Inflammation, Osteoarthritis (OA), Osteoarthritis of the Knee, Pain, Pain caused by Rheumatism, Pericarditis, Photophobia, Postoperative Inflammatory Response, Postoperative pain, Primary Dysmenorrhoea, Radicular Pain, Rheumatism, Rheumatoid Arthritis, Seasonal Allergic Conjunctivitis, Spinal pain, Tendon pain, Vertebral column pain, Acute Musculoskeletal injury, Acute, moderate, severe Pain, Inflammatory, Localized soft tissue rheumatism, Mild to moderate joint pain, Mild to moderate pain, Minor pain, Perioperative miosis

Intravitreal Diclofenac Versus Avastin as Primary Treatment of Diffuse Diabetic Macular Edema

Phase 1
Conditions
Diffuse Diabetic Macular Edema
Interventions
First Posted Date
2009-10-22
Last Posted Date
2010-05-04
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Registration Number
NCT00999791
Locations
🇮🇷

Ophthalmic Research Center, Tehran, Iran, Islamic Republic of

Study of Diclofenac Capsules to Treat Dental Pain

Phase 2
Completed
Conditions
Dental Pain
Interventions
First Posted Date
2009-09-28
Last Posted Date
2012-05-22
Lead Sponsor
Iroko Pharmaceuticals, LLC
Target Recruit Count
202
Registration Number
NCT00985439
Locations
🇺🇸

Premier Research Group Limited, Austin, Texas, United States

Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain

Phase 3
Completed
Conditions
Grade I/II Ankle Sprain
Interventions
First Posted Date
2009-08-10
Last Posted Date
2012-04-20
Lead Sponsor
Novartis
Target Recruit Count
242
Registration Number
NCT00955513
Locations
🇩🇪

Novartis Investigative Site, Munchen, Germany

Etoricoxib in Acute Ankle Ligament Sprains

Phase 4
Withdrawn
Conditions
Sprain
Interventions
First Posted Date
2009-08-07
Last Posted Date
2013-06-20
Lead Sponsor
University of Cape Town
Registration Number
NCT00954785
Locations
🇿🇦

Kuilsriver Netcare Hospital, 33 Van Riebeeck Road, Kuilsriver, Cape Town, Western Cape, South Africa

🇿🇦

Sports Medicine Clinic, Sports Science Institute of South Africa, Cape Town, Western Cape, South Africa

Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery

Phase 3
Completed
Conditions
Dental Pain
Interventions
Drug: Voltarol 75mg/3ml i.m.
First Posted Date
2009-07-22
Last Posted Date
2013-01-28
Lead Sponsor
IBSA Institut Biochimique SA
Target Recruit Count
142
Registration Number
NCT00943098
Locations
🇬🇧

The School of Clinical Dentistry, The University of Sheffield, Sheffield, United Kingdom

🇬🇧

The School of Dentistry, University of Birmingham, Birmingham, United Kingdom

🇬🇧

Department of oral Surgery; University Dental Hospital, Cardiff, United Kingdom

Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery

Phase 3
Completed
Conditions
Dental Pain
Interventions
Other: Placebo s.c.
First Posted Date
2009-07-21
Last Posted Date
2013-01-28
Lead Sponsor
IBSA Institut Biochimique SA
Target Recruit Count
306
Registration Number
NCT00942448
Locations
🇵🇱

Gabinet Stomatologiczny Bartek, Kobyłka, Poland

🇬🇧

The School of Dentistry; University of Birmingham, Birmingham, United Kingdom

🇵🇱

Niepubliczny Zakład Opieki Zdrowotnej, Warszawa, Poland

and more 3 locations

Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Soft Tissue Injuries (TAPED)

Phase 3
Completed
Conditions
Acute Pain
Soft Tissue Injury
Interventions
Drug: Matching Placebo Patch
First Posted Date
2009-07-02
Last Posted Date
2010-08-16
Lead Sponsor
Cerimon Pharmaceuticals
Target Recruit Count
407
Registration Number
NCT00931866
Locations
🇺🇸

PPD, Austin, Texas, United States

To Demonstrate the Relative Bioavailability of Diclofenac Sodium 50 mg Enteric-Coated Tablets

First Posted Date
2009-06-04
Last Posted Date
2017-03-28
Lead Sponsor
Sandoz
Target Recruit Count
38
Registration Number
NCT00913224
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