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

Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium

First Posted Date
2007-05-16
Last Posted Date
2008-01-04
Lead Sponsor
Javelin Pharmaceuticals
Target Recruit Count
36
Registration Number
NCT00474136
Locations
🇺🇸

PAREXEL International, Baltimore, Maryland, United States

The Standard Care Versus Celecoxib Outcome Trial

Phase 4
Completed
Conditions
Rheumatoid Arthritis
Osteoarthritis
Interventions
First Posted Date
2007-03-15
Last Posted Date
2019-05-03
Lead Sponsor
University of Dundee
Target Recruit Count
7297
Registration Number
NCT00447759
Locations
🇳🇱

Julius Clinical Research, Zeist, Netherlands

🇬🇧

University of Dundee, Dundee, United Kingdom

🇬🇧

NHS Highlands, Inverness, United Kingdom

and more 7 locations

Efficacy and Safety of Diclofenac Sodium (0.1%) Gel in Patients With UV Induced Painful Sunburn

Phase 3
Completed
Conditions
Sunburn
First Posted Date
2007-02-28
Last Posted Date
2007-02-28
Lead Sponsor
Novartis
Target Recruit Count
45
Registration Number
NCT00441051
Locations
🇫🇷

CPCAD, Nice, France

Diclofenac for the Prevention of Post-ERCP Pancreatitis in Higher Risk Patients

Phase 4
Terminated
Conditions
Pancreatitis
Interventions
Drug: placebo
First Posted Date
2007-01-29
Last Posted Date
2015-09-22
Lead Sponsor
Queen's University
Target Recruit Count
23
Registration Number
NCT00428025
Locations
🇨🇦

Kingston General Hospital, Kingston, Ontario, Canada

Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis

Phase 3
Completed
Conditions
Osteoarthritis of the Knee
Interventions
First Posted Date
2007-01-25
Last Posted Date
2007-12-18
Lead Sponsor
Novartis
Target Recruit Count
420
Registration Number
NCT00426621
Locations
🇺🇸

Holston Medical Group, Kingsport, Tennessee, United States

🇺🇸

North Carolina Arthritis & Allergy Care Center, Raleigh, North Carolina, United States

🇺🇸

Texas Research Center, LLP, Sugar Land, Texas, United States

and more 58 locations

Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins

Phase 4
Completed
Conditions
Superficial Thrombophlebitis of the Upper Limb
First Posted Date
2006-09-18
Last Posted Date
2007-12-10
Lead Sponsor
Novartis
Target Recruit Count
200
Registration Number
NCT00377806
Locations
🇩🇪

Novartis, Nürnberg, Germany

Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery

Phase 3
Completed
Conditions
Pain, Postoperative
Interventions
First Posted Date
2006-09-13
Last Posted Date
2010-09-21
Lead Sponsor
Xanodyne Pharmaceuticals
Target Recruit Count
200
Registration Number
NCT00375934
Locations
🇺🇸

Investigative Site, Salt Lake City, Utah, United States

Feasibility of n-of-1 Trials - a Pilot Study

Phase 2
Completed
Conditions
Osteoarthritis
First Posted Date
2006-09-04
Last Posted Date
2006-09-04
Lead Sponsor
University of Bristol
Target Recruit Count
10
Registration Number
NCT00371696
Locations
🇬🇧

Southmead Hospital, Bristol, United Kingdom

Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery

Phase 3
Completed
Conditions
Pain, Postoperative
Interventions
First Posted Date
2006-08-21
Last Posted Date
2011-04-13
Lead Sponsor
Xanodyne Pharmaceuticals
Target Recruit Count
201
Registration Number
NCT00366444
Locations
🇺🇸

Investigative Site, Salt Lake City, Utah, United States

An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack

Phase 3
Completed
Conditions
Migraine
Photophobia
Phonophobia
First Posted Date
2006-05-29
Last Posted Date
2007-04-02
Lead Sponsor
ProEthic Pharmaceuticals
Target Recruit Count
650
Registration Number
NCT00330850
Locations
🇺🇸

Mercy Health Research, St. Louis, Missouri, United States

🇺🇸

Diamond Headache Clinic, Chicago, Illinois, United States

🇺🇸

DermResearch, Inc., Austin, Texas, United States

and more 13 locations
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