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

AbbVie

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis of the Knee

Treatments: Drug: Placebo; Drug: Naproxen; Drug: ABT-652

Study type: Interventional

Funder types: Industry

Identifiers

NCT01207115

M10-889

Details and patient eligibility

About

To compare the analgesic efficacy and safety of ABT-652 administered twice daily (BID) to placebo in subjects with osteoarthritis (OA) of the knee.

Enrollment: 322 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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322 participants in 4 patient groups, including a placebo group

ABT-652 high dose

Experimental group

Description:

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

Treatment:

Drug: ABT-652

ABT-652 low dose

Experimental group

Description:

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

Treatment:

Drug: ABT-652

Naproxen

Active Comparator group

Description:

Naproxen capsules- twice daily for 8 weeks

Treatment:

Drug: Naproxen

Placebo

Placebo Comparator group

Description:

Placebo capsules- twice daily for 8 weeks

Treatment:

Drug: Placebo