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

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444365
• Other study ID #: M13-237
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2011
• Last updated: May 7, 2013
• Start date: October 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• ABT-652 NSAID
ABT-652 capsules - 2 ABT-652 capsules twice daily (add-on) NSAID- as prescribed
• Placebo NSAID
Placebo - 2 placebo capsules twice daily NSAID- as prescribed

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 61257	Anaheim	California
United States	Site Reference ID/Investigator# 61205	Beaumont	Texas
United States	Site Reference ID/Investigator# 61210	Brockton	Massachusetts
United States	Site Reference ID/Investigator# 61218	Bryan	Texas
United States	Site Reference ID/Investigator# 61273	Cincinnati	Ohio
United States	Site Reference ID/Investigator# 61234	DeLand	Florida
United States	Site Reference ID/Investigator# 61232	Draper	Utah
United States	Site Reference ID/Investigator# 61238	Duncansville	Pennsylvania
United States	Site Reference ID/Investigator# 61244	Florissant	Missouri
United States	Site Reference ID/Investigator# 61269	Franklin	Wisconsin
United States	Site Reference ID/Investigator# 61246	Fresno	California
United States	Site Reference ID/Investigator# 61242	La Mesa	California
United States	Site Reference ID/Investigator# 61204	Long Beach	California
United States	Site Reference ID/Investigator# 61263	Marietta	Georgia
United States	Site Reference ID/Investigator# 61265	Milford	Connecticut
United States	Site Reference ID/Investigator# 61258	North Hollywood	California
United States	Site Reference ID/Investigator# 61213	Ocala	Florida
United States	Site Reference ID/Investigator# 61228	Oklahoma City	Oklahoma
United States	Site Reference ID/Investigator# 61211	Oldsmar	Florida
United States	Site Reference ID/Investigator# 61206	Omaha	Nebraska
United States	Site Reference ID/Investigator# 61217	Orlando	Florida
United States	Site Reference ID/Investigator# 61221	Phoenix	Arizona
United States	Site Reference ID/Investigator# 61226	Phoenix	Arizona
United States	Site Reference ID/Investigator# 61231	Plantation	Florida
United States	Site Reference ID/Investigator# 61264	Portland	Oregon
United States	Site Reference ID/Investigator# 61223	Salisbury	North Carolina
United States	Site Reference ID/Investigator# 61235	San Antonio	Texas
United States	Site Reference ID/Investigator# 61266	St. Louis	Missouri
United States	Site Reference ID/Investigator# 61245	Tampa	Florida
United States	Site Reference ID/Investigator# 61241	Tucson	Arizona
United States	Site Reference ID/Investigator# 61260	Watertown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject's Assessment of Arthritis Pain Intensity	Subject reported 24-hour average pain score measured by Visual Analogue Scale	6 weeks	No
Secondary	Western Ontario and McMaster (WOMAC™ ) Osteoarthritis Index	Self administered, patient-centered, health status questionnaire	6 weeks	No
Secondary	Subject's Global Assessment of Arthritis Status	Subject reported pain intensity measured by Visual Analog Scale	6 weeks	No
Secondary	Cognitive Functioning in Patients with Chronic Pain	Subject reported assessment of cognitive functioning	6 weeks	No