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

Bayer

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Drug: Naproxen Sodium (Aleve, BAY117031); Drug: Acetaminophen ER; Drug: Placebo; Drug: Celecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03570554

19783

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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41 participants in 4 patient groups

Treatment A-D-C-B

Experimental group

Description:

Participants received naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by placebo for 4 days; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.

Treatment:

Drug: Placebo

Drug: Acetaminophen ER

Drug: Naproxen Sodium (Aleve, BAY117031)

Drug: Celecoxib

Treatment B-C-D-A

Experimental group

Description:

Participants received acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by placebo for 4 days; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days.

Treatment:

Drug: Placebo

Drug: Acetaminophen ER

Drug: Naproxen Sodium (Aleve, BAY117031)

Drug: Celecoxib

Treatment C-A-B-D

Experimental group

Description:

Participants received celecoxib 200 mg daily for 3 days and 100 mg on the fourth day; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by placebo for 4 days. Treatment periods were separated by a washout period of 3 to 7 days.

Treatment:

Drug: Placebo

Drug: Acetaminophen ER

Drug: Naproxen Sodium (Aleve, BAY117031)

Drug: Celecoxib

Treatment D-B-A-C

Experimental group

Description:

Participants received placebo for 4 days; followed by acetaminophen 3900 mg daily for 3 days and 1300 mg on the fourth day; followed by naproxen 660 mg daily for 3 days and 440 mg on the fourth day; followed by celecoxib 200 mg daily for 3 days and 100 mg on the fourth day. Treatment periods were separated by a washout period of 3 to 7 days

Treatment:

Drug: Placebo

Drug: Acetaminophen ER

Drug: Naproxen Sodium (Aleve, BAY117031)

Drug: Celecoxib