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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

Diclofenac add-on to Treatment as Usual for Suicidal Patients

Phase 1
Withdrawn
Conditions
Depression Suicidal
Interventions
Drug: sugar pill
First Posted Date
2011-08-10
Last Posted Date
2019-01-10
Lead Sponsor
Region Skane
Registration Number
NCT01413854
Locations
🇸🇪

Psychiatry Skane, Lund, Sweden

The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis

Phase 4
Completed
Conditions
Knee Osteoarthritis
Interventions
First Posted Date
2011-06-28
Last Posted Date
2017-08-15
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
52
Registration Number
NCT01383954
Locations
🇺🇸

Brigham and Women's Hospital, Chestnut Hill, Massachusetts, United States

Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine

Early Phase 1
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2011-06-27
Last Posted Date
2020-02-19
Lead Sponsor
Northwestern University
Target Recruit Count
30
Registration Number
NCT01380353
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

Topical Vitamin D3, Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma

Phase 2
Completed
Conditions
Basal Cell Carcinoma
Interventions
First Posted Date
2011-05-23
Last Posted Date
2015-01-13
Lead Sponsor
Maastricht University Medical Center
Target Recruit Count
128
Registration Number
NCT01358045
Locations
🇳🇱

Maastricht University Medical Center, Maastricht, Limburg, Netherlands

Efficacy of PENNSAID® for Pain Management in the Emergency Department

Not Applicable
Withdrawn
Conditions
Pain
Ankle Sprain
Interventions
First Posted Date
2011-05-10
Last Posted Date
2016-12-21
Lead Sponsor
University of Utah
Registration Number
NCT01350622
Locations
🇺🇸

University of Utah, Salt Lake City, Utah, United States

Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain

Phase 4
Completed
Conditions
Neck Pain
Interventions
First Posted Date
2011-04-14
Last Posted Date
2012-07-18
Lead Sponsor
Novartis
Target Recruit Count
72
Registration Number
NCT01335724
Locations
🇩🇪

NCH investigative site, Munich, Germany

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain

Phase 3
Completed
Conditions
Acute Ankle Sprain
Interventions
First Posted Date
2011-01-10
Last Posted Date
2013-01-24
Lead Sponsor
Novartis
Target Recruit Count
205
Registration Number
NCT01272934
Locations
🇩🇪

NCH investigative site, Gilching, Germany

🇩🇪

NCH investigative site, Munich, Germany., Munich, Germany

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries

Phase 3
Completed
Conditions
Acute Blunt Soft Tissue Injuries/Contusions
Interventions
First Posted Date
2011-01-10
Last Posted Date
2013-01-10
Lead Sponsor
Novartis
Target Recruit Count
204
Registration Number
NCT01272947
Locations
🇩🇪

NCH investigative site, Munich, Germany

Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients

First Posted Date
2010-12-21
Last Posted Date
2020-05-27
Lead Sponsor
Western Galilee Hospital-Nahariya
Registration Number
NCT01263652

Efficacy of Diclofenac Potassium vs Nimesulide in the Treatment of Fever and Pain in Children With Upper Respiratory Tract Infection

Phase 4
Withdrawn
Conditions
Upper Respiratory Tract Infections
Interventions
First Posted Date
2010-12-09
Last Posted Date
2012-04-26
Lead Sponsor
Novartis Pharmaceuticals
Registration Number
NCT01257126
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