A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale

• Status: Completed
• Trial end date: 2019-06-14
• Target enrollment: 0
• Participant gender: All

Summary

Osteoarthritis is a common, chronic, progressive, skeletal, degenerative disorder that frequently affects several joints such as knee, hip, spine and hands.This placebo-controlled clinical trial assessed the effects of naproxen sodium, acetaminophen and celecoxib on stiffness in subjects with osteoarthritis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Acetaminophen; Celecoxib; Naproxen

Criteria

Inclusion Criteria:

• Age between 40 and 80 years

• Body Mass Index (BMI) between 18 and <40 kg/m^2

• Unilateral or bilateral osteoarthritis of the knee

• Diagnostic quality radiography of the target knee performed no more than 1 year prior to baseline showing evidence of osteoarthritis (OA) with Kellgren and Lawrence grade of II or III

• Joint Stiffness Severity score ≥3.0 on a 0-10 numerical rating scale (NRS) at screening

Exclusion Criteria:

• History of underlying inflammatory arthropathy, rheumatoid arthritis or fibromyalgia

• History of or scheduled for target knee replacement surgery

• Recent injury in target knee (past 4 months)