A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee

Osteoarthritis of the Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207115
• Other study ID #: M10-889
• Status: Completed
• Phase: Phase 2
• First received: September 21, 2010
• Last updated: January 2, 2013
• Start date: September 2010
• Est. completion date: May 2011

Study information

• Verified date: January 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaChile: Instituto de Salud Pública de ChileAustralia: Department of Health and Ageing Therapeutic Goods AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Australia	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
Canada	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
Chile	Site Reference ID/Investigator# 41951	Santiago
Puerto Rico	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
United States	Site Reference ID/Investigator# 37221	Anaheim	California
United States	Site Reference ID/Investigator# 37208	Austin	Texas
United States	Site Reference ID/Investigator# 37229	Boynton Beach	Florida
United States	Site Reference ID/Investigator# 37217	Brooklyn Center	Minnesota
United States	Site Reference ID/Investigator# 37222	Burbank	California
United States	Site Reference ID/Investigator# 37220	Chandler	Arizona
United States	Site Reference ID/Investigator# 35956	Chino	California
United States	Site Reference ID/Investigator# 37214	Duncansville	Pennsylvania
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# 35959	New York	New York
United States	Site Reference ID/Investigator# 37209	Ocala	Florida
United States	Site Reference ID/Investigator# 37212	Plantation	Florida
United States	Site Reference ID/Investigator# 35953	Richmond	Virginia
United States	Site Reference ID/Investigator# 37211	Salisbury	North Carolina
United States	Site Reference ID/Investigator# 37213	San Antonio	Texas
United States	Site Reference ID/Investigator# 35961	South Miami	Florida
United States	Site Reference ID/Investigator# 37228	St. Louis	Missouri
United States	Site Reference ID/Investigator# 37223	Tempe	Arizona
United States	Site Reference ID/Investigator# 37215	Tucson	Arizona
United States	Site Reference ID/Investigator# 37207	Valparaiso	Indiana
United States	Site Reference ID/Investigator# 37205	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Chile,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour average pain score measured by Visual Analog Scale	Subject reported pain intensity measured by Visual Analog Scale (0-100)	8 weeks	No
Secondary	Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores	Self administered, patient-centered, health status questionnaire	8 weeks	No
Secondary	Subject's Global Assessment of Arthritis Status	Subject reported assessment of arthritis status measured by Visual Analogue Scale (0-100)	8 weeks	No
Secondary	Brief Pain Inventory	Subject reported pain intensity and intereference (scale 0-10)	8 weeks	No
Secondary	SF-36v2™ Health Status Survey	There is no formal title for this quality of life survey, this is the only name for this measure. Subject reported quality of life survey	8 weeks	No