Treatment of Knee Pain With Topical Diclofenac Cream 8% or Diclofenac Gel 1%

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by FPR Specialty Pharmacy
Sponsor:
Information provided by (Responsible Party):
FPR Specialty Pharmacy
ClinicalTrials.gov Identifier:
NCT02068859
First received: February 18, 2014
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

Non-steroidal anti-inflammatory medication (NSAID) therapy is a mainstay treatment for joint pain and painful musculoskeletal disorders. Though this form of systemic therapy is highly effective, it causes substantial side effects including gastritis and gastric ulcer disease, renal impairment, hypertension, and thrombotic events. These types of oral medications are utilized by millions of Americans on a fairly regular basis in both over-the-counter preparations and prescription compounds. In recent years, topical preparations of NSAIDs have been used for localized pain as an alternate to oral administration with reported good analgesic efficacy. For example, they are often used for knee pain. There is little systemic absorption of NSAIDs with topical administration, and consequently less likelihood of systemic side effects.

Though much less studied than oral NSAIDs, topical NSAID preparations are currently prescribed for a variety of arthritic and musculoskeletal types of pain. The best-studied commercially available products are diclofenac 1% compounds. Higher concentrations presumably provide higher tissue concentration leading to better and longer pain relief, along with a more prominent anti-inflammatory effect.

The investigators will therefore compare the efficacy of available topical diclofenac 1% gel to that of diclofenac 8% cream. Specifically, the investigators propose to test the hypothesis that efficacy of topical diclofenac 8% exceeds that of diclofenac 1%, without any increase in systemic toxicity.

One hundred six patients presenting to the Cleveland Clinic Pain Management Department for the treatment of knee pain will be randomly assigned to topical diclofenac cream 8% or diclofenac gel 1%, with the designated medication applied the symptomatic area of the knee over 6 weeks. Investigators will be blinded to treatment, and will evaluate pain relief and functional/disability status.


Condition Intervention Phase
Knee Pain Chronic
Knee Injuries
Drug: Diclofenac Cream 8%
Drug: Diclofenac Gel 1%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Knee Pain With Topical Diclofenac Cream 8% or Diclofenac Gel 1%

Resource links provided by NLM:


Further study details as provided by FPR Specialty Pharmacy:

Primary Outcome Measures:
  • Descrete Response Scale Pain Scores [ Time Frame: Daily measurement for 6 weeks ] [ Designated as safety issue: No ]
    Patients will maintain a daily home pain diary. This will be recorded in the evening each day over the six week treatment period with documentation of minimum, maximum, and overall average daily pain on a 0-10/10 discrete response scale (DRS).


Estimated Enrollment: 106
Study Start Date: January 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diclofenac Cream 8%
Diclofenac Cream 8% applied 3-4 times daily for 6 weeks.
Drug: Diclofenac Cream 8%
Subjects will be given instructions to apply the study drug topically 3-4 times daily to the affected knee. Application instructions will also be printed on the tubes of products.
Active Comparator: Control
Diclofenac Gel 1% applied 3-4 times daily fr 6 weeks
Drug: Diclofenac Gel 1%
Subjects will be given instructions to apply the study drug topically 3-4 times daily to the affected knee. Application instructions will also be printed on the tubes of products.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Acute and chronic knee pain, along with postoperative knee pain lasting at least two months.

Exclusion Criteria:

  • Patients will be excluded if deemed inappropriate for application of topical medication therapy by the treating physician. This will include adult patients with diffuse (non-localized) pain disorders and those likely to need knee surgery during the treatment period.
  • Patients with knee infection, open knee wounds, or acute knee skin lesions will be excluded.
  • Patients with diclofenac or wheat or gluten allergies will also be excluded.
  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: NCT02068859

Locations
United States, Ohio
Anesthesia Administration - Outcomes Research Recruiting
Cleveland, Ohio, United States, 44195
Contact: Roberta Johnson    216-444-9950    johnsor13@ccf.org   
Principal Investigator: Daniel J Leizman, MD         
Sponsors and Collaborators
FPR Specialty Pharmacy
  More Information

No publications provided

Responsible Party: FPR Specialty Pharmacy
ClinicalTrials.gov Identifier: NCT02068859     History of Changes
Other Study ID Numbers: FPRSpecialty-0001-CC
Study First Received: February 18, 2014
Last Updated: February 20, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Knee Injuries
Leg Injuries
Wounds and Injuries
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 September 18, 2014