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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

Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5%

Phase 4
Completed
Conditions
Acute Pseudophakic Cystoid Macular Edema
Interventions
First Posted Date
2008-01-16
Last Posted Date
2009-03-19
Lead Sponsor
Bp Consulting, Inc
Target Recruit Count
166
Registration Number
NCT00595543
Locations
🇺🇸

Soll Eye Associates, Philadelphia, Pennsylvania, United States

Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain

Phase 2
Completed
Conditions
Ankle Sprain
Interventions
First Posted Date
2007-12-14
Last Posted Date
2012-04-20
Lead Sponsor
Novartis
Target Recruit Count
271
Registration Number
NCT00573768
Locations
🇩🇪

Novartis Investigative Site, Stockach, Germany

Platelet Function and Safety After IV and Oral Diclofenac, IV Ketorolac and Oral Aspirin in Adult Volunteers

First Posted Date
2007-10-24
Last Posted Date
2008-07-16
Lead Sponsor
Javelin Pharmaceuticals
Target Recruit Count
30
Registration Number
NCT00548678
Locations
🇺🇸

Comprehensive Phase One, Miramar, Florida, United States

Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial II

Phase 3
Completed
Conditions
Osteoarthritis
Interventions
First Posted Date
2007-10-19
Last Posted Date
2010-10-13
Lead Sponsor
Mika Pharma GmbH
Target Recruit Count
650
Registration Number
NCT00546832

Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial I

Phase 3
Completed
Conditions
Osteoarthritis
Interventions
First Posted Date
2007-10-19
Last Posted Date
2010-10-13
Lead Sponsor
Mika Pharma GmbH
Target Recruit Count
650
Registration Number
NCT00546507

Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED)

Phase 3
Completed
Conditions
Osteoarthritis
First Posted Date
2007-10-10
Last Posted Date
2024-08-15
Lead Sponsor
Organon and Co
Target Recruit Count
516
Registration Number
NCT00542087

Topical Voltaren in Otitis Externa

Phase 2
Terminated
Conditions
Otitis Externa
Interventions
First Posted Date
2007-08-30
Last Posted Date
2016-04-20
Lead Sponsor
Sieff Medical Center
Target Recruit Count
20
Registration Number
NCT00523120
Locations
🇮🇱

Sieff Medical Center, Safed, Israel

Study to Assess Effects of Age, Weight, and Body Composition on the Pharmacokinetics of IV Diclofenac Sodium

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2007-07-31
Last Posted Date
2009-02-12
Lead Sponsor
Javelin Pharmaceuticals
Target Recruit Count
89
Registration Number
NCT00509743
Locations
🇺🇸

Comprehensive Phase One, Miramar, Florida, United States

🇺🇸

PAREXEL International, Baltimore, Maryland, United States

Normothermia in Patients With Acute Cerebral Damage

Phase 4
Conditions
Subarachnoid Hemorrhage
Traumatic Brain Injury
First Posted Date
2007-06-26
Last Posted Date
2007-09-20
Lead Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Registration Number
NCT00491192
Locations
🇮🇹

Fondazione Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan, Italy

Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications

Not Applicable
Completed
Conditions
Uveitis
Iritis
Iridocyclitis
Anterior Uveitis
Macular Edema
Interventions
First Posted Date
2007-05-22
Last Posted Date
2017-05-01
Lead Sponsor
Norwegian University of Science and Technology
Target Recruit Count
218
Registration Number
NCT00476593
Locations
🇳🇴

Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway

🇳🇴

Department of Ophthalmology, St Olavs University Hospital, Trondheim, Norway

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