Clinical trial NCT01207115: A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee
Official title: A Global Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-652 to Placebo in Subjects With Osteoarthritis Pain of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-09-22
Enrollment: 322
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 compare the analgesic efficacy and safety of ABT-652 administered twice daily (BID) to placebo in subjects with osteoarthritis (OA) of the knee.


Eligibility criteria: Inclusion Criteria

* History of OA of the knee joint and meeting American College of Rheumatology (ACR) Clinical and Radiographic criteria,
* Pain score as required by the protocol at Screening and Baseline
* Willing to washout of analgesics and to follow treatment plan, visit schedules and study procedures.

Exclusion Criteria

* History of sensitivity to histamine medications, acetaminophen (paracetamol), or non-steroidal anti-inflammatory drugs (NSAIDs)
* Active gastrointestinal (GI) disease, GI bleeding or GI ulceration, or history of GI bleeding or GI ulceration in the last 6 months
* History of major psychiatric disorders
* 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 or other medical condition or illness that is not well controlled with treatment

Primary outcomes:
measure: 24-hour average pain score measured by Visual Analog Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores
timeFrame: 8 weeks
measure: Subject's Global Assessment of Arthritis Status
timeFrame: 8 weeks
measure: Brief Pain Inventory
timeFrame: 8 weeks
measure: SF-36v2™ Health Status Survey
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Site Reference ID/Investigator# 37220
state: Arizona
city: Tempe
country: United States
facility: Site Reference ID/Investigator# 37223
state: Arizona
city: Tucson
country: United States
facility: Site Reference ID/Investigator# 37215
state: Arizona
city: Anaheim
country: United States
facility: Site Reference ID/Investigator# 37221
state: California
city: Burbank
country: United States
facility: Site Reference ID/Investigator# 37222
state: California
city: Chino
country: United States
facility: Site Reference ID/Investigator# 35956
state: California
city: La Mesa
country: United States
facility: Site Reference ID/Investigator# 37053
state: California
city: Lomita
country: United States
facility: Site Reference ID/Investigator# 37218
state: California
city: Milford
country: United States
facility: Site Reference ID/Investigator# 37227
state: Connecticut
city: Boynton Beach
country: United States
facility: Site Reference ID/Investigator# 37229
state: Florida
city: Ocala
country: United States
facility: Site Reference ID/Investigator# 37209
state: Florida
city: Plantation
country: United States
facility: Site Reference ID/Investigator# 37212
state: Florida
city: South Miami
country: United States
facility: Site Reference ID/Investigator# 35961
state: Florida
city: Valparaiso
country: United States
facility: Site Reference ID/Investigator# 37207
state: Indiana
city: Brooklyn Center
country: United States
facility: Site Reference ID/Investigator# 37217
state: Minnesota
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 37228
state: Missouri
city: New York
country: United States
facility: Site Reference ID/Investigator# 35959
state: New York
city: Salisbury
country: United States
facility: Site Reference ID/Investigator# 37211
state: North Carolina
city: Duncansville
country: United States
facility: Site Reference ID/Investigator# 37214
state: Pennsylvania
city: Wyomissing
country: United States
facility: Site Reference ID/Investigator# 37205
state: Pennsylvania
city: Austin
country: United States
facility: Site Reference ID/Investigator# 37208
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 37213
state: Texas
city: Richmond
country: United States
facility: Site Reference ID/Investigator# 35953
state: Virginia
city: Brisbane
country: Australia
facility: Site Reference ID/Investigator# 41782
city: Campsie, Sydney
country: Australia
facility: Site Reference ID/Investigator# 41779
city: Clayton
country: Australia
facility: Site Reference ID/Investigator# 41778
city: Fitzroy
country: Australia
facility: Site Reference ID/Investigator# 41785
city: Kogarah
country: Australia
facility: Site Reference ID/Investigator# 41582
city: Malvern East
country: Australia
facility: Site Reference ID/Investigator# 41776
city: Montreal
country: Canada
facility: Site Reference ID/Investigator# 41563
city: Newmarket
country: Canada
facility: Site Reference ID/Investigator# 41566
city: Pointe-Claire
country: Canada
facility: Site Reference ID/Investigator# 41565
city: Sainte-Foy, Quebec
country: Canada
facility: Site Reference ID/Investigator# 41562
city: Santiago
country: Chile
facility: Site Reference ID/Investigator# 41951
city: Caguas
country: Puerto Rico
facility: Site Reference ID/Investigator# 37183
city: Ponce
country: Puerto Rico
facility: Site Reference ID/Investigator# 37622
city: San Juan
country: Puerto Rico
facility: Site Reference ID/Investigator# 35966
city: Trujillo Alto
country: Puerto Rico
facility: Site Reference ID/Investigator# 37184
Study officials:
affiliation: AbbVie
name: Rachel Duan, MD
role: STUDY_DIRECTOR
References: