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

Phase 2

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Drug: ABT-652; Drug: Naproxen; Drug: Placebo

• Registration Number: NCT01207115
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-21
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-22
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Disposition First Submitted: 2012-05-04
• Disposition First Submitted QC: 2012-05-04
• Disposition First Posted: 2012-05-08
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-02
• Last Update Posted: 2013-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABT-652 high dose	ABT-652	ABT-652 capsules- twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm.
Naproxen	Naproxen	Naproxen capsules- twice daily for 8 weeks
Placebo	Placebo	Placebo capsules- twice daily for 8 weeks
ABT-652 low dose	ABT-652	ABT-652 capsules - twice daily for 8 weeks. The dose ABT-652 will depend on the Arm

Primary Outcome Measures

Name	Time	Method
24-hour average pain score measured by Visual Analog Scale	8 weeks	Subject reported pain intensity measured by Visual Analog Scale (0-100)

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores	8 weeks	Self administered, patient-centered, health status questionnaire
Subject's Global Assessment of Arthritis Status	8 weeks	Subject reported assessment of arthritis status measured by Visual Analogue Scale (0-100)
Brief Pain Inventory	8 weeks	Subject reported pain intensity and intereference (scale 0-10)
SF-36v2™ Health Status Survey	8 weeks	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

Trial Locations

Locations (38)

Site Reference ID/Investigator# 37222; 🇺🇸 Burbank, 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# 37221; 🇺🇸 Anaheim, California, United States

Site Reference ID/Investigator# 37223; 🇺🇸 Tempe, Arizona, United States

Site Reference ID/Investigator# 37218; 🇺🇸 Lomita, California, United States

Site Reference ID/Investigator# 37183; 🇵🇷 Caguas, Puerto Rico

Site Reference ID/Investigator# 41582; 🇦🇺 Kogarah, Australia

Site Reference ID/Investigator# 41779; 🇦🇺 Campsie, Sydney, Australia

Site Reference ID/Investigator# 41776; 🇦🇺 Malvern East, Australia

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# 37211; 🇺🇸 Salisbury, North Carolina, 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# 37214; 🇺🇸 Duncansville, Pennsylvania, United States

Site Reference ID/Investigator# 41951; 🇨🇱 Santiago, Chile

Site Reference ID/Investigator# 41563; 🇨🇦 Montreal, Canada

Site Reference ID/Investigator# 41565; 🇨🇦 Pointe-Claire, Canada

Site Reference ID/Investigator# 35966; 🇵🇷 San Juan, Puerto Rico

Site Reference ID/Investigator# 41566; 🇨🇦 Newmarket, Canada

Site Reference ID/Investigator# 41562; 🇨🇦 Sainte-Foy, Quebec, Canada

Site Reference ID/Investigator# 37209; 🇺🇸 Ocala, Florida, United States

Site Reference ID/Investigator# 37215; 🇺🇸 Tucson, Arizona, United States

Site Reference ID/Investigator# 41782; 🇦🇺 Brisbane, Australia

Site Reference ID/Investigator# 37622; 🇵🇷 Ponce, Puerto Rico

Site Reference ID/Investigator# 37184; 🇵🇷 Trujillo Alto, Puerto Rico

Site Reference ID/Investigator# 37212; 🇺🇸 Plantation, Florida, United States

Site Reference ID/Investigator# 37053; 🇺🇸 La Mesa, 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# 41778; 🇦🇺 Clayton, Australia

Site Reference ID/Investigator# 41785; 🇦🇺 Fitzroy, Australia

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# 37205; 🇺🇸 Wyomissing, Pennsylvania, United States