A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee
NCT ID: NCT01207115
Last Updated: 2013-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
322 participants
INTERVENTIONAL
2010-09-30
2011-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee
NCT01444365
Acute Osteoarthritis Experimental Model Study.
NCT01231490
Trial of Naproxen to Evaluate Various Methods of Measuring Analgesic Effect in Osteoarthritis Pain of the Knee
NCT01557816
Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
NCT00542555
A Study Of The Effect Of CE-224535 On Knee OA (Osteoarthritis) Pain
NCT00418782
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ABT-652 high dose
ABT-652 capsules- twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm.
ABT-652
ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm
ABT-652 low dose
ABT-652 capsules - twice daily for 8 weeks. The dose ABT-652 will depend on the Arm
ABT-652
ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm
Naproxen
Naproxen capsules- twice daily for 8 weeks
Naproxen
Naproxen capsules - twice daily for 8 weeks
Placebo
Placebo capsules- twice daily for 8 weeks
Placebo
Placebo capsules - twice daily for 8 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ABT-652
ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm
Placebo
Placebo capsules - twice daily for 8 weeks
Naproxen
Naproxen capsules - twice daily for 8 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
* 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
40 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rachel Duan, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site Reference ID/Investigator# 37220
Chandler, Arizona, United States
Site Reference ID/Investigator# 37223
Tempe, Arizona, United States
Site Reference ID/Investigator# 37215
Tucson, Arizona, United States
Site Reference ID/Investigator# 37221
Anaheim, California, United States
Site Reference ID/Investigator# 37222
Burbank, California, United States
Site Reference ID/Investigator# 35956
Chino, California, United States
Site Reference ID/Investigator# 37053
La Mesa, California, United States
Site Reference ID/Investigator# 37218
Lomita, California, United States
Site Reference ID/Investigator# 37227
Milford, Connecticut, United States
Site Reference ID/Investigator# 37229
Boynton Beach, Florida, United States
Site Reference ID/Investigator# 37209
Ocala, Florida, United States
Site Reference ID/Investigator# 37212
Plantation, Florida, United States
Site Reference ID/Investigator# 35961
South Miami, Florida, United States
Site Reference ID/Investigator# 37207
Valparaiso, Indiana, United States
Site Reference ID/Investigator# 37217
Brooklyn Center, Minnesota, United States
Site Reference ID/Investigator# 37228
St Louis, Missouri, United States
Site Reference ID/Investigator# 35959
New York, New York, United States
Site Reference ID/Investigator# 37211
Salisbury, North Carolina, United States
Site Reference ID/Investigator# 37214
Duncansville, Pennsylvania, United States
Site Reference ID/Investigator# 37205
Wyomissing, Pennsylvania, United States
Site Reference ID/Investigator# 37208
Austin, Texas, United States
Site Reference ID/Investigator# 37213
San Antonio, Texas, United States
Site Reference ID/Investigator# 35953
Richmond, Virginia, United States
Site Reference ID/Investigator# 41782
Brisbane, , Australia
Site Reference ID/Investigator# 41779
Campsie, Sydney, , Australia
Site Reference ID/Investigator# 41778
Clayton, , Australia
Site Reference ID/Investigator# 41785
Fitzroy, , Australia
Site Reference ID/Investigator# 41582
Kogarah, , Australia
Site Reference ID/Investigator# 41776
Malvern East, , Australia
Site Reference ID/Investigator# 41563
Montreal, , Canada
Site Reference ID/Investigator# 41566
Newmarket, , Canada
Site Reference ID/Investigator# 41565
Pointe-Claire, , Canada
Site Reference ID/Investigator# 41562
Sainte-Foy, Quebec, , Canada
Site Reference ID/Investigator# 41951
Santiago, , Chile
Site Reference ID/Investigator# 37183
Caguas, , Puerto Rico
Site Reference ID/Investigator# 37622
Ponce, , Puerto Rico
Site Reference ID/Investigator# 35966
San Juan, , Puerto Rico
Site Reference ID/Investigator# 37184
Trujillo Alto, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M10-889
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.