NCT01119898

Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis

A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Clinical Study to Evaluate the Safety and Efficacy of PENNSAID Gel in the Symptomatic Treatment of Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Osteoarthritis (OA) is the most common form of arthritis. It can cause pain, swelling, and reduced motion in the joints. That can reduce quality of life. OA can occur in any joint, but usually affects the hands, knees, hips or spine. The purpose of this study is to find out if doctors might be able to use 2% PENNSAID gel to treat OA in the knee.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	PENNSAID Gel	2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
DRUG	Vehicle	2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks

Timeline

• Start date: 2010-08-02
• Primary completion: 2011-02-16
• Completion: 2011-02-16
• First posted: 2010-05-10
• Last updated: 2019-10-22
• Results posted: 2019-10-22

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study