A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee

A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of ABT-652 as an Add On Therapy in Subjects With Osteoarthritis of the Knee Experiencing Partial Benefit of a Nonsteroidal Anti-Inflammatory Drug

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01444365

Enrollment

202

Registered

2011-09-30

Start date

2011-10-31

Completion date

2012-04-30

Last updated

2013-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis of the knee

Brief summary

To evaluate the safety and efficacy of ABT-652 in combination with a Non-steroidal Anti-inflammatory Drug (NSAID) compared to NSAID alone in adults with osteoarthritis (OA) of the knee.

Detailed description

This is a randomized withdrawal design study, containing a 4 week open-label period followed by a 6 week double-blind period. The total treatment period will be 10 weeks.

Interventions

DRUGABT-652 NSAID

ABT-652 capsules - 2 ABT-652 capsules twice daily (add-on) NSAID- as prescribed

DRUGPlacebo NSAID

Placebo - 2 placebo capsules twice daily NSAID- as prescribed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

* History of osteoarthritis (OA) of the knee joint and meeting American College of Rheumatology (ACR) Clinical and Radiographic criteria, * Currently taking nonsteroidal anti-inflammatory drugs (NSAIDs) and still experiencing pain as per the protocol requirements. * Willing to washout of analgesics and to follow treatment plan, visit schedules and study procedures.

Exclusion criteria

* Diagnosis of rheumatoid arthritis, autoimmune disorder, arthritis other than osteoarthritis involving the study joint, or other painful syndrome that could interfere with the assessment of pain at the study joint * Any cardiac, respiratory, neurological, psychiatric disorder or any other medical condition or illness that is not well controlled with treatment

Design outcomes

Primary

Measure	Time frame	Description
Subject's Assessment of Arthritis Pain Intensity	6 weeks	Subject reported 24-hour average pain score measured by Visual Analogue Scale

Secondary

Measure	Time frame	Description
Western Ontario and McMaster (WOMAC™ ) Osteoarthritis Index	6 weeks	Self administered, patient-centered, health status questionnaire
Subject's Global Assessment of Arthritis Status	6 weeks	Subject reported pain intensity measured by Visual Analog Scale
Cognitive Functioning in Patients with Chronic Pain	6 weeks	Subject reported assessment of cognitive functioning

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026