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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

Celecoxib Versus Diclofenac In The Treatment Of Osteoarthritis Of The Hip

Phase 4
Completed
Conditions
Osteoarthritis, Hip
First Posted Date
2005-09-15
Last Posted Date
2006-12-05
Lead Sponsor
Pfizer
Target Recruit Count
250
Registration Number
NCT00174317
Locations
🇬🇧

Pfizer Investigational Site, Wigan, United Kingdom

Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

Phase 3
Completed
Conditions
Osteoarthritis
First Posted Date
2005-09-15
Last Posted Date
2006-10-11
Lead Sponsor
Novartis
Target Recruit Count
360
Registration Number
NCT00171652

A Study of Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement (0966-259)

Phase 4
Terminated
Conditions
Pain
First Posted Date
2005-09-01
Last Posted Date
2017-05-09
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
11
Registration Number
NCT00140920

Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis

Phase 4
Completed
Conditions
Osteoarthritis
Arthritis, Rheumatoid
Interventions
First Posted Date
2005-09-01
Last Posted Date
2021-03-03
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Target Recruit Count
4484
Registration Number
NCT00141102
Locations
🇬🇧

Pfizer Investigational Site, Wansford, United Kingdom

Parecoxib in Renal Colic

Phase 3
Terminated
Conditions
Colic
First Posted Date
2005-08-31
Last Posted Date
2008-05-06
Lead Sponsor
Pfizer
Target Recruit Count
50
Registration Number
NCT00139646
Locations
🇮🇹

Pfizer Investigational Site, Siena, Italy

Investigational Drug Versus an Approved Drug in Patients With Rheumatoid Arthritis (0663-072)

Phase 3
Completed
Conditions
Rheumatoid Arthritis
First Posted Date
2004-09-28
Last Posted Date
2022-02-16
Lead Sponsor
Organon and Co
Target Recruit Count
4086
Registration Number
NCT00092742

Investigational Drug Versus an Approved Drug in Patients With Osteoarthritis (0663-061)(COMPLETED)

Phase 3
Completed
Conditions
Osteoarthritis
First Posted Date
2004-09-28
Last Posted Date
2024-08-15
Lead Sponsor
Organon and Co
Target Recruit Count
6000
Registration Number
NCT00092703

A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)

Phase 3
Completed
Conditions
Postoperative Pain
First Posted Date
2004-09-27
Last Posted Date
2017-05-09
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
251
Registration Number
NCT00092378

Study of MK0663 in Patients With Chronic Low Back Pain (0663-806)(COMPLETED)

Phase 4
Completed
Conditions
Chronic Low Back Pain
First Posted Date
2004-08-27
Last Posted Date
2022-02-15
Lead Sponsor
Organon and Co
Target Recruit Count
401
Registration Number
NCT00090181
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