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: April 26, 2013
Last verified: April 2013
  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: Voltaren
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 Brigham and Women's Hospital:

Primary Outcome Measures:
  • percent improvement in pain [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks ] [ Designated as safety issue: No ]
    The primary outcome measure is the percent improvement in pain (prior to gel-1 hour after gel) after each diclofenac gel application for breakthrough pain. This is calculated from the pain ratings input into the ED just prior to and after gel application. Sample size calculations use a power of .85, an alpha level of .05, a pre-gel pain level of ~7/10, a standard deviation of response of 1.6, and T test comparisons. We estimate that 30 subjects will be needed to find a 30% improvement in breakthrough pain on average in the cohort.


Enrollment: 60
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
diclofenic gel
5 Week study to determine the efficacy of diclofenic gel on Knee Osteoarthritis.
Drug: Voltaren
All subjects will be prescribed diclofenac gel: 4 grams applied QID to the affected knee. Subjects will take a maximum dosage of 32g/day
Other Name: diclofenic gel

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 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 20-75
  • Unilateral or bilateral knee OA, confirmed radiographically.
  • Patients taking oral NSAIDs in the amount and schedule prior to the breakthrough period will be permitted.

Exclusion Criteria:

  • Patients with clinical history of ACL involvement.
  • Patients on tricyclic antidepressants or anticonvulsants (neuropathic medications)
  • History of ulcers or 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

No publications provided

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
Last Updated: April 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 26, 2014