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Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis

NCT01119898 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2019-10-22

Study results available
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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

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

Sponsors & Collaborators

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Joseph Pierro, MD · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-02
Primary Completion
2011-02-16
Completion
2011-02-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01119898 on ClinicalTrials.gov