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: C_₁₄H_₁₁Cl_₂NO_₂

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

Clinical Trials

Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants

Phase 3

Completed

Conditions: Coagulopathy
Osteoarthritis of the Knee

Interventions: Drug: Pennsaid

First Posted Date: 2012-01-19

Last Posted Date: 2014-06-26

Lead Sponsor: Nathan Wei, MD, FACP, FACR:

Target Recruit Count: 22

Registration Number: NCT01511939

Locations: 🇺🇸
Arthritis Treatment Center, Frederick, Maryland, United States

Open-Label Study of Diclofenac Capsules to Treat Osteoarthritis Pain

Phase 3

Completed

Conditions: Osteoarthritis

Interventions: Drug: Diclofenac

First Posted Date: 2012-01-18

Last Posted Date: 2014-05-09

Lead Sponsor: Iroko Pharmaceuticals, LLC

Target Recruit Count: 602

Registration Number: NCT01510912

Locations: 🇺🇸
Heartland Research Associates, LLC, Newton, Kansas, United States
🇺🇸
Professional Research Network of Kansas, LLC, Wichita, Kansas, United States
🇺🇸
Clinical Trials Technology Inc, Prairie Village, Kansas, United States

and more 33 locations

Effects of Pennsaid on Clinical Neuropathic Pain

Not Applicable

Completed

Conditions: Neuralgia
Complex Regional Pain Syndrome (CRPS)
Reflex Sympathetic Dystrophy
Postherpetic Neuralgia

Interventions: Drug: Pennsaid
Drug: Placebo (2.3% DMSO solution)

First Posted Date: 2012-01-12

Last Posted Date: 2017-02-06

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 35

Registration Number: NCT01508676

Locations: 🇺🇸
MGH Center for Translational Pain Research, Boston, Massachusetts, United States

Safety Study of Renal Function in Patients With Chronic Kidney Failure Taking Lumiracoxib or Diclofenac for Arthralgia

Phase 2

Terminated

Conditions: Kidney Failure, Chronic
Arthralgia

Interventions: Drug: Lumiracoxib
Drug: Diclofenac

First Posted Date: 2011-11-29

Last Posted Date: 2013-02-13

Lead Sponsor: Hospital Central Sur de Pemex

Target Recruit Count: 28

Registration Number: NCT01481610

Locations: 🇲🇽
Hospital Central Sur de Alta Especialidad PEMEX, Mexico City, DF, Mexico

Study of Diclofenac Capsules to Treat Pain Following Bunionectomy

Phase 3

Completed

Conditions: Other Acute Postoperative Pain

Interventions: Drug: Diclofenac Test (lower dose)
Drug: Diclofenac Test (upper dose)
Drug: Celecoxib
Drug: Placebo

First Posted Date: 2011-10-31

Last Posted Date: 2014-02-04

Lead Sponsor: Iroko Pharmaceuticals, LLC

Target Recruit Count: 428

Registration Number: NCT01462435

Locations: 🇺🇸
Chesapeake Research Group, LLC, Pasadena, Maryland, United States
🇺🇸
Premier Research Group Limited, Salt Lake City, Utah, United States

Study of Diclofenac Capsules to Treat Osteoarthritis Pain

Phase 3

Completed

Conditions: Osteoarthritis

Interventions: Drug: Diclofenac
Drug: Placebo

First Posted Date: 2011-10-28

Last Posted Date: 2014-05-26

Lead Sponsor: Iroko Pharmaceuticals, LLC

Target Recruit Count: 305

Registration Number: NCT01461369

Locations: 🇺🇸
Heartland Research Associates, LLC, Newton, Kansas, United States
🇺🇸
Professional Research Network of Kansas, LLC, Wichita, Kansas, United States
🇺🇸
Westside Center for Clinical Research, Jacksonville, Florida, United States

and more 33 locations

Adjuvant Treatment of Graves´ Ophthalmopathy With NSAID (aGO Study)

Phase 4

Completed

Conditions: Graves´ Disease

Interventions: Drug: Diclofenac
Drug: Methimazole
Drug: Propranolol
Drug: L-thyroxin
Drug: Metoprolol

First Posted Date: 2011-10-25

Last Posted Date: 2016-02-24

Lead Sponsor: Mikael Lantz

Target Recruit Count: 65

Registration Number: NCT01458600

Locations: 🇸🇪
Departmenty of Endocrinology, Skane University Hospital, Malmö, Sweden
🇸🇪
Department of Endocrinology, Karolinska Hospital, Stockholm, Sweden
🇸🇪
Department of Internal Medicine, section of Endocrinology, Sodersjukhuset, Stockholm, Sweden

Evaluation of Clinical Endpoints of Two Diclofenac Sodium Gel 1%

Phase 3

Completed

Conditions: Osteo Arthritis of the Knee

Interventions: Drug: Placebo
Drug: Diclofenac

First Posted Date: 2011-10-21

Last Posted Date: 2012-07-12

Lead Sponsor: Anchen Pharmaceuticals, Inc

Target Recruit Count: 749

Registration Number: NCT01456611

Locations: 🇺🇸
Novum Investigator Site, Newport News, Virginia, United States

Diclofenac Sodium Topical Gel to Reduce Injection Site Discomfort in Patients Taking Glatiramer Acetate

Phase 4

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: diclofenac sodium topical gel
Other: Placebo

First Posted Date: 2011-10-19

Last Posted Date: 2015-03-05

Lead Sponsor: Brown, Theodore R., M.D., MPH

Target Recruit Count: 40

Registration Number: NCT01454791

Locations: 🇺🇸
MS Center at Evergreen Healthcare, Kirkland, Washington, United States

Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA 2)

Phase 4

Completed

Conditions: Actinic Keratosis

Interventions: Drug: Imiquimod
Drug: Diclofenac

First Posted Date: 2011-10-17

Last Posted Date: 2022-02-07

Lead Sponsor: MEDA Pharma GmbH & Co. KG

Target Recruit Count: 221

Registration Number: NCT01453179

Locations: 🇩🇪
Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venerology, Magdeburg, Germany
🇦🇹
Medical University Vienna, Department for General Dermatology, Vienna, Austria
🇩🇪
Medical Practice, Münster, Germany

and more 8 locations

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