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

NCT02068859 | Unknown Phase 3

• 1 other identifier: FPRSpecialty-0001-CC
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Diclofenac Cream 8%

EXPERIMENTAL

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

Drug: Diclofenac Cream 8%

Control

ACTIVE COMPARATOR

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

Drug: Diclofenac Gel 1%

Interventions

Diclofenac Cream 8% 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.

Diclofenac Cream 8%

Diclofenac Gel 1% 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• FPR Specialty Pharmacy: lead

Study Sites (1)

Anesthesia Administration - Outcomes Research

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 21, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: February 21, 2014

Record last verified: 2014-02

Locations

US (1)