Clinical trial NCT01444365: A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis of the knee
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-09-30
Enrollment: 202
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subject's Assessment of Arthritis Pain Intensity
timeFrame: 6 weeks
Secondary outcomes:
measure: Western Ontario and McMaster (WOMAC™ ) Osteoarthritis Index
timeFrame: 6 weeks
measure: Subject's Global Assessment of Arthritis Status
timeFrame: 6 weeks
measure: Cognitive Functioning in Patients with Chronic Pain
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Site Reference ID/Investigator# 61226
state: Arizona
city: Phoenix
country: United States
facility: Site Reference ID/Investigator# 61221
state: Arizona
city: Tucson
country: United States
facility: Site Reference ID/Investigator# 61241
state: Arizona
city: Anaheim
country: United States
facility: Site Reference ID/Investigator# 61257
state: California
city: Fresno
country: United States
facility: Site Reference ID/Investigator# 61246
state: California
city: La Mesa
country: United States
facility: Site Reference ID/Investigator# 61242
state: California
city: Long Beach
country: United States
facility: Site Reference ID/Investigator# 61204
state: California
city: North Hollywood
country: United States
facility: Site Reference ID/Investigator# 61258
state: California
city: Milford
country: United States
facility: Site Reference ID/Investigator# 61265
state: Connecticut
city: DeLand
country: United States
facility: Site Reference ID/Investigator# 61234
state: Florida
city: Ocala
country: United States
facility: Site Reference ID/Investigator# 61213
state: Florida
city: Oldsmar
country: United States
facility: Site Reference ID/Investigator# 61211
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 61217
state: Florida
city: Plantation
country: United States
facility: Site Reference ID/Investigator# 61231
state: Florida
city: Tampa
country: United States
facility: Site Reference ID/Investigator# 61245
state: Florida
city: Marietta
country: United States
facility: Site Reference ID/Investigator# 61263
state: Georgia
city: Brockton
country: United States
facility: Site Reference ID/Investigator# 61210
state: Massachusetts
city: Watertown
country: United States
facility: Site Reference ID/Investigator# 61260
state: Massachusetts
city: Florissant
country: United States
facility: Site Reference ID/Investigator# 61244
state: Missouri
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 61266
state: Missouri
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 61206
state: Nebraska
city: Salisbury
country: United States
facility: Site Reference ID/Investigator# 61223
state: North Carolina
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 61273
state: Ohio
city: Oklahoma City
country: United States
facility: Site Reference ID/Investigator# 61228
state: Oklahoma
city: Portland
country: United States
facility: Site Reference ID/Investigator# 61264
state: Oregon
city: Duncansville
country: United States
facility: Site Reference ID/Investigator# 61238
state: Pennsylvania
city: Beaumont
country: United States
facility: Site Reference ID/Investigator# 61205
state: Texas
city: Bryan
country: United States
facility: Site Reference ID/Investigator# 61218
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 61235
state: Texas
city: Draper
country: United States
facility: Site Reference ID/Investigator# 61232
state: Utah
city: Franklin
country: United States
facility: Site Reference ID/Investigator# 61269
state: Wisconsin
Study officials:
affiliation: AbbVie
name: Wolfram Nothaft, MD
role: STUDY_DIRECTOR
References: