NCT03570554

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of the study was to assess the responsiveness of the Brief Arthritis Stiffness Scale (BASS) for detecting treatment effects of common over-the-counter (OTC) analgesics and a common prescription analgesic in subjects with knee osteoarthritis.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Naproxen Sodium (Aleve, BAY117031)	660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A)
DRUG	Acetaminophen ER	3900 mg daily for 3 days, 1300 mg on the fourth day, over-encapsulated extended release (ER) tablet, oral (Treatment B)
DRUG	Celecoxib	200 mg daily for 3 days, 100 mg on the fourth day, over-encapsulated capsule, oral (Treatment C)
DRUG	Placebo	Over-encapsulation capsule, 4 days, oral (Treatment D)

Timeline

• Start date: 2018-06-29
• Primary completion: 2019-06-14
• Completion: 2019-06-14
• First posted: 2018-06-27
• Last updated: 2020-06-19
• Results posted: 2020-06-19

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study