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

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.

Study Overview

• Status: Unknown
• Conditions: Knee Injuries; Knee Pain Chronic
• Intervention / Treatment: Drug: Diclofenac Cream 8%; Drug: Diclofenac Gel 1%

• Study Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Anesthesia Administration - Outcomes Research
      • Principal Investigator: Daniel J Leizman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descrete Response Scale Pain Scores	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).	Daily measurement for 6 weeks

Collaborators and Investigators

• Sponsor: FPR Specialty Pharmacy

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): January 1, 2015

Study Registration Dates

• First Submitted: February 18, 2014
• First Submitted That Met QC Criteria: February 20, 2014
• First Posted (Estimate): February 21, 2014

Study Record Updates

• Last Update Posted (Estimate): February 21, 2014
• Last Update Submitted That Met QC Criteria: February 20, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: FPRSpecialty-0001-CC