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

NCT01383954 | Completed Phase 4 Results

• 1 other identifier: 2009p000667
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this proposed study is to conduct a trial with knee osteoarthritis (OA) patients using the diclofenac gel.

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Percent Change From Baseline in Pain Score During Week 1

  Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 1 were averaged. Percent change from Baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit) / (value at baseline) x 100. A positive change from Baseline indicates improvement.

  Baseline and Week 1

• Percent Change From Baseline in Pain Score During Week 2

  Participants assessed their knee pain using a visual analog scale (VAS) where 0=no pain and 100=worst possible pain. Pain scores were recorded in an electronic diary prior to and 4 hours after the first daily application of diclofenac gel for breakthrough pain. The daily percent change in pain scores over the 7 days prior to Week 2 were averaged. Percent change from baseline (average pain score 7 days prior to first treatment) was calculated as (value at baseline - value at post-baseline visit)/ (value at baseline) x 100. A positive change from baseline indicates improvement.

  Baseline and Week 2

Study Arms (1)

Diclofenac gel

OTHER

Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.

Drug: Diclofenac Gel

Interventions

Diclofenac Gel DRUG

Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.

Also known as: Voltaren

Diclofenac gel

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 20-75
• Unilateral or bilateral knee osteoarthritis (OA), confirmed radiographically.
• Patients taking oral non-steroidal anti-inflammatory drugs (NSAIDs) in the amount and schedule prior to the breakthrough period will be permitted.

You may not qualify if:

• Patients with clinical history of anterior cruciate ligament (ACL) involvement.
• Patients on tricyclic antidepressants or anticonvulsants (neuropathic medications)
• History of ulcers or gastrointestinal (GI) bleeding
• Coagulation disorders
• Hypersensitivity to Aspirin or NSAIDS
• Congestive Heart Failure and Edema
• Advanced renal disease
• Aspirin triad
• Pregnant women

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Endo Pharmaceuticals: collaborator

Study Sites (1)

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

Related Publications (1)

• Edwards RR, Dolman AJ, Martel MO, Finan PH, Lazaridou A, Cornelius M, Wasan AD. Variability in conditioned pain modulation predicts response to NSAID treatment in patients with knee osteoarthritis. BMC Musculoskelet Disord. 2016 Jul 13;17:284. doi: 10.1186/s12891-016-1124-6.

  PMID: 27412526 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Ajay D. Wasan, M.D., M.Sc.
• Organization: Brigham and Women's Hospital

awasan@partners.org

Study Officials

• Ajay D Wasan, M.D

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 28, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 15, 2017
• Results First Posted: July 6, 2017

Record last verified: 2017-07

Locations

US (1)