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

NCT01207115 | Completed Phase 2 DMC

• 1 other identifier: M10-889
• Study Type: interventional
• Target: 322
• Locations: 5 countries
• Sites: 38

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.

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• 24-hour average pain score measured by Visual Analog Scale

  Subject reported pain intensity measured by Visual Analog Scale (0-100)

  8 weeks

Secondary Outcomes (4)

• Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores

  8 weeks

• Subject's Global Assessment of Arthritis Status

  8 weeks

• Brief Pain Inventory

  8 weeks

• SF-36v2™ Health Status Survey

  8 weeks

Study Arms (4)

ABT-652 high dose

EXPERIMENTAL

ABT-652 capsules- twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm.

Drug: ABT-652

ABT-652 low dose

EXPERIMENTAL

ABT-652 capsules - twice daily for 8 weeks. The dose ABT-652 will depend on the Arm

Drug: ABT-652

Naproxen

ACTIVE COMPARATOR

Naproxen capsules- twice daily for 8 weeks

Drug: Naproxen

Placebo

PLACEBO COMPARATOR

Placebo capsules- twice daily for 8 weeks

Drug: Placebo

Interventions

ABT-652 DRUG

ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm

ABT-652 high dose; ABT-652 low dose

Placebo DRUG

Placebo capsules - twice daily for 8 weeks

Placebo

Naproxen DRUG

Naproxen capsules - twice daily for 8 weeks

Naproxen

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (38)

Site Reference ID/Investigator# 37220

Chandler, Arizona, 85224, United States

Location

Site Reference ID/Investigator# 37223

Tempe, Arizona, 85282, United States

Location

Site Reference ID/Investigator# 37215

Tucson, Arizona, 85704, United States

Location

Site Reference ID/Investigator# 37221

Anaheim, California, 92801, United States

Location

Site Reference ID/Investigator# 37222

Burbank, California, 91505, United States

Location

Site Reference ID/Investigator# 35956

Chino, California, 91710, United States

Location

Site Reference ID/Investigator# 37053

La Mesa, California, 91942, United States

Location

Site Reference ID/Investigator# 37218

Lomita, California, 90717, United States

Location

Site Reference ID/Investigator# 37227

Milford, Connecticut, 06460, United States

Location

Site Reference ID/Investigator# 37229

Boynton Beach, Florida, 33472, United States

Location

Site Reference ID/Investigator# 37209

Ocala, Florida, 34471, United States

Location

Site Reference ID/Investigator# 37212

Plantation, Florida, 33317, United States

Location

Site Reference ID/Investigator# 35961

South Miami, Florida, 33143, United States

Location

Site Reference ID/Investigator# 37207

Valparaiso, Indiana, 46383, United States

Location

Site Reference ID/Investigator# 37217

Brooklyn Center, Minnesota, 55430, United States

Location

Site Reference ID/Investigator# 37228

St Louis, Missouri, 63141, United States

Location

Site Reference ID/Investigator# 35959

New York, New York, 10004, United States

Location

Site Reference ID/Investigator# 37211

Salisbury, North Carolina, 28144, United States

Location

Site Reference ID/Investigator# 37214

Duncansville, Pennsylvania, 16635, United States

Location

Site Reference ID/Investigator# 37205

Wyomissing, Pennsylvania, 19610, United States

Location

Site Reference ID/Investigator# 37208

Austin, Texas, 78705, United States

Location

Site Reference ID/Investigator# 37213

San Antonio, Texas, 78209-1744, United States

Location

Site Reference ID/Investigator# 35953

Richmond, Virginia, 23294, United States

Location

Site Reference ID/Investigator# 41782

Brisbane, 4102, Australia

Location

Site Reference ID/Investigator# 41779

Campsie, Sydney, 2194, Australia

Location

Site Reference ID/Investigator# 41778

Clayton, 3168, Australia

Location

Site Reference ID/Investigator# 41785

Fitzroy, VIC 3065, Australia

Location

Site Reference ID/Investigator# 41582

Kogarah, 2217, Australia

Location

Site Reference ID/Investigator# 41776

Malvern East, 3145, Australia

Location

Site Reference ID/Investigator# 41563

Montreal, H2L 1S6, Canada

Location

Site Reference ID/Investigator# 41566

Newmarket, L3Y 3R7, Canada

Location

Site Reference ID/Investigator# 41565

Pointe-Claire, H9J 3W3, Canada

Location

Site Reference ID/Investigator# 41562

Sainte-Foy, Quebec, G1W 4R4, Canada

Location

Site Reference ID/Investigator# 41951

Santiago, Chile

Location

Site Reference ID/Investigator# 37183

Caguas, 00725, Puerto Rico

Location

Site Reference ID/Investigator# 37622

Ponce, 00716, Puerto Rico

Location

Site Reference ID/Investigator# 35966

San Juan, 00936-8344, Puerto Rico

Location

Site Reference ID/Investigator# 37184

Trujillo Alto, 00976, Puerto Rico

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Rachel Duan, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 22, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 7, 2013

Record last verified: 2013-01

Locations

CA (4); PR (4); CL (1); US (23); AU (6)