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

NCT ID: NCT02068859

Last Updated: 2014-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-01-31

Brief Summary

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.

Conditions

Knee Pain Chronic; Knee Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Diclofenac Cream 8%

Diclofenac Cream 8% applied 3-4 times daily for 6 weeks.

Group Type: EXPERIMENTAL

Diclofenac Cream 8%

Intervention Type: DRUG

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.

Control

Diclofenac Gel 1% applied 3-4 times daily fr 6 weeks

Group Type: ACTIVE_COMPARATOR

Diclofenac Gel 1%

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

FPR Specialty Pharmacy

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Anesthesia Administration - Outcomes Research

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Roberta Johnson

Role: primary

johnsor13@ccf.org

216-444-9950

Other Identifiers

FPRSpecialty-0001-CC

Identifier Type: -

Identifier Source: org_study_id