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

This study has been completed.
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01383954
First received: June 22, 2011
Last updated: June 7, 2017
Last verified: June 2017
  Purpose
The purpose of this proposed study is to conduct a trial with knee osteoarthritis (OA) patients using the diclofenac gel.

Condition Intervention Phase
Knee Osteoarthritis Drug: Diclofenac Gel Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital:

Primary Outcome Measures:
  • Percent Change From Baseline in Pain Score During Week 1 [ Time Frame: Baseline and 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.

  • Percent Change From Baseline in Pain Score During Week 2 [ Time Frame: Baseline and 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.


Enrollment: 52
Actual Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Diclofenac gel
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
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.
Other Name: Voltaren

Detailed Description:
The purpose of this proposed study is to conduct a trial with knee OA patients using the diclofenac gel. The effectiveness of diclofenac gel in managing breakthrough pain or the neuropathic components of pain (e.g., the burning, soft tissue joint sensitivity, or allodynic components) in knee OA is unknown. It is likely that patients will use the gel in a as needed (prn) fashion, on top of other analgesics prescribed for their pain. The neuropathic components of a generally nociceptive or inflammatory condition, such as knee OA, are underappreciated, and typically not tracked in OA analgesic studies. Yet, evidence across a variety of chronic painful conditions suggests that these components are quite disabling. The results of this study would show whether diclofenac gel as a prn medication is beneficial to patients suffering from knee OA pain.
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383954

Locations
United States, Massachusetts
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Brigham and Women's Hospital
Endo Pharmaceuticals
Investigators
Principal Investigator: Ajay D Wasan, M.D Brigham and Women's Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ajay D. Wasan,M.D.,M.Sc., Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01383954     History of Changes
Other Study ID Numbers: 2009p000667
Study First Received: June 22, 2011
Results First Received: April 5, 2017
Last Updated: June 7, 2017

Keywords provided by Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital:
Knee osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Breakthrough Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 19, 2017