MedPath

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
Associated Therapies
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"NSAIDs in Acute Achilles Tendinopathy: Effect on Pain Control, Leg Stiffness and Functional Recovery in Athletes"

Phase 4
Completed
Conditions
Achilles Tendinopathy
Interventions
First Posted Date
2008-11-17
Last Posted Date
2013-08-06
Lead Sponsor
Argentine Tennis Association
Target Recruit Count
56
Registration Number
NCT00792376
Locations
🇦🇷

Argentine Tennis Association, Buenos Aires, Argentina

Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses

Phase 4
Completed
Conditions
Actinic Keratosis
Interventions
First Posted Date
2008-10-22
Last Posted Date
2022-02-07
Lead Sponsor
MEDA Pharma GmbH & Co. KG
Target Recruit Count
258
Registration Number
NCT00777127
Locations
🇫🇷

Hospital Sainte Marguerite, Department for Dermatology and Venereology, Pavilion 3, First Floor, Marseille, France

🇫🇷

CHU St Jacques, Department for Dermatology, Besancon Cedex, France

🇩🇪

Derma Center Vechta, Vechta, Germany

and more 23 locations

An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs)

Phase 4
Terminated
Conditions
Spondylitis, Ankylosing
Pain
Interventions
First Posted Date
2008-10-06
Last Posted Date
2014-10-15
Lead Sponsor
Johnson & Johnson Taiwan Ltd
Target Recruit Count
8
Registration Number
NCT00766402

A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib And Diclofenac In Patients With A Sprained Ankle

Phase 4
Completed
Conditions
Pain
Sprains and Strains
Sprain
Interventions
First Posted Date
2008-05-05
Last Posted Date
2008-05-05
Lead Sponsor
Pfizer
Target Recruit Count
202
Registration Number
NCT00671320
Locations
🇵🇪

Pfizer Investigational Site, Lima, Peru

A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy for Anterior Cruciate Ligament (ACL) Reconstruction

Phase 4
Completed
Conditions
Pain, Postoperative
Interventions
First Posted Date
2008-04-02
Last Posted Date
2008-10-08
Lead Sponsor
Pfizer
Target Recruit Count
328
Registration Number
NCT00650598
Locations

Pfizer Investigational Site

Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain

Phase 4
Completed
Conditions
Low Back Pain
Interventions
First Posted Date
2008-04-01
Last Posted Date
2008-04-10
Lead Sponsor
Pfizer
Target Recruit Count
340
Registration Number
NCT00649610
Locations
🇻🇪

Pfizer Investigational Site, Caracas, Venezuela

Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis

Phase 3
Completed
Conditions
Spondylitis, Ankylosing
Interventions
First Posted Date
2008-04-01
Last Posted Date
2008-04-10
Lead Sponsor
Pfizer
Target Recruit Count
458
Registration Number
NCT00648141
Locations
🇩🇪

Pfizer Investigational Site, Winsen/Luhe, Germany

Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain

Phase 4
Completed
Conditions
Low Back Pain
Interventions
First Posted Date
2008-03-21
Last Posted Date
2021-02-02
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
244
Registration Number
NCT00640432
Locations
🇧🇷

Pfizer Investigational Site, São Paulo, SP, Brazil

Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain

Phase 2
Terminated
Conditions
Ankle Sprain
Interventions
Drug: Matching placebo patch
Drug: diclofenac sodium
First Posted Date
2008-03-21
Last Posted Date
2008-09-04
Lead Sponsor
Cerimon Pharmaceuticals
Target Recruit Count
170
Registration Number
NCT00640705
Locations
🇺🇸

PPD, Austin, Texas, United States

Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis

Phase 2
Completed
Conditions
Rotator Cuff Tendonitis
Bicipital Tendonitis
Subdeltoid Bursitis of the Shoulder
Subacromial Bursitis of the Shoulder
Medial Epicondylitis of the Elbow
Lateral Epicondylitis of the Elbow
DeQuervain's Tenosynovitis of the Wrist
Interventions
Drug: diclofenac sodium
Drug: Matching Placebo
First Posted Date
2008-03-21
Last Posted Date
2008-08-06
Lead Sponsor
Cerimon Pharmaceuticals
Target Recruit Count
308
Registration Number
NCT00640939
Locations
🇺🇸

PPD, Austin, Texas, United States

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