search
Back to results

A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ABT-652 NSAID
Placebo NSAID
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis of the knee

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of osteoarthritis (OA) of the knee joint and meeting American College of Rheumatology (ACR) Clinical and Radiographic criteria,
  • Currently taking nonsteroidal anti-inflammatory drugs (NSAIDs) and still experiencing pain as per the protocol requirements.
  • Willing to washout of analgesics and to follow treatment plan, visit schedules and study procedures.

Exclusion Criteria:

  • 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, psychiatric disorder or any other medical condition or illness that is not well controlled with treatment

Sites / Locations

  • Site Reference ID/Investigator# 61226
  • Site Reference ID/Investigator# 61221
  • Site Reference ID/Investigator# 61241
  • Site Reference ID/Investigator# 61257
  • Site Reference ID/Investigator# 61246
  • Site Reference ID/Investigator# 61242
  • Site Reference ID/Investigator# 61204
  • Site Reference ID/Investigator# 61258
  • Site Reference ID/Investigator# 61265
  • Site Reference ID/Investigator# 61234
  • Site Reference ID/Investigator# 61213
  • Site Reference ID/Investigator# 61211
  • Site Reference ID/Investigator# 61217
  • Site Reference ID/Investigator# 61231
  • Site Reference ID/Investigator# 61245
  • Site Reference ID/Investigator# 61263
  • Site Reference ID/Investigator# 61210
  • Site Reference ID/Investigator# 61260
  • Site Reference ID/Investigator# 61244
  • Site Reference ID/Investigator# 61266
  • Site Reference ID/Investigator# 61206
  • Site Reference ID/Investigator# 61223
  • Site Reference ID/Investigator# 61273
  • Site Reference ID/Investigator# 61228
  • Site Reference ID/Investigator# 61264
  • Site Reference ID/Investigator# 61238
  • Site Reference ID/Investigator# 61205
  • Site Reference ID/Investigator# 61218
  • Site Reference ID/Investigator# 61235
  • Site Reference ID/Investigator# 61232
  • Site Reference ID/Investigator# 61269

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ABT-652 NSAID

Placebo NSAID

Arm Description

ABT-652 capsules -2 ABT-652 capsules twice daily (add-on) NSAID - as prescribed

Placebo - 2 placebo capsules twice daily NSAID - as prescribed

Outcomes

Primary Outcome Measures

Subject's Assessment of Arthritis Pain Intensity
Subject reported 24-hour average pain score measured by Visual Analogue Scale

Secondary Outcome Measures

Western Ontario and McMaster (WOMAC™ ) Osteoarthritis Index
Self administered, patient-centered, health status questionnaire
Subject's Global Assessment of Arthritis Status
Subject reported pain intensity measured by Visual Analog Scale
Cognitive Functioning in Patients with Chronic Pain
Subject reported assessment of cognitive functioning

Full Information

First Posted
September 28, 2011
Last Updated
May 7, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
search

1. Study Identification

Unique Protocol Identification Number
NCT01444365
Brief Title
A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee
Official Title
A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of ABT-652 as an Add On Therapy in Subjects With Osteoarthritis of the Knee Experiencing Partial Benefit of a Nonsteroidal Anti-Inflammatory Drug
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the safety and efficacy of ABT-652 in combination with a Non-steroidal Anti-inflammatory Drug (NSAID) compared to NSAID alone in adults with osteoarthritis (OA) of the knee.
Detailed Description
This is a randomized withdrawal design study, containing a 4 week open-label period followed by a 6 week double-blind period. The total treatment period will be 10 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Osteoarthritis of the knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-652 NSAID
Arm Type
Experimental
Arm Description
ABT-652 capsules -2 ABT-652 capsules twice daily (add-on) NSAID - as prescribed
Arm Title
Placebo NSAID
Arm Type
Placebo Comparator
Arm Description
Placebo - 2 placebo capsules twice daily NSAID - as prescribed
Intervention Type
Drug
Intervention Name(s)
ABT-652 NSAID
Intervention Description
ABT-652 capsules - 2 ABT-652 capsules twice daily (add-on) NSAID- as prescribed
Intervention Type
Drug
Intervention Name(s)
Placebo NSAID
Intervention Description
Placebo - 2 placebo capsules twice daily NSAID- as prescribed
Primary Outcome Measure Information:
Title
Subject's Assessment of Arthritis Pain Intensity
Description
Subject reported 24-hour average pain score measured by Visual Analogue Scale
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster (WOMAC™ ) Osteoarthritis Index
Description
Self administered, patient-centered, health status questionnaire
Time Frame
6 weeks
Title
Subject's Global Assessment of Arthritis Status
Description
Subject reported pain intensity measured by Visual Analog Scale
Time Frame
6 weeks
Title
Cognitive Functioning in Patients with Chronic Pain
Description
Subject reported assessment of cognitive functioning
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of osteoarthritis (OA) of the knee joint and meeting American College of Rheumatology (ACR) Clinical and Radiographic criteria, Currently taking nonsteroidal anti-inflammatory drugs (NSAIDs) and still experiencing pain as per the protocol requirements. Willing to washout of analgesics and to follow treatment plan, visit schedules and study procedures. Exclusion Criteria: 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, psychiatric disorder or any other medical condition or illness that is not well controlled with treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolfram Nothaft, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 61226
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Site Reference ID/Investigator# 61221
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Site Reference ID/Investigator# 61241
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Site Reference ID/Investigator# 61257
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Site Reference ID/Investigator# 61246
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
Site Reference ID/Investigator# 61242
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Site Reference ID/Investigator# 61204
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Site Reference ID/Investigator# 61258
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Site Reference ID/Investigator# 61265
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Site Reference ID/Investigator# 61234
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Site Reference ID/Investigator# 61213
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Site Reference ID/Investigator# 61211
City
Oldsmar
State/Province
Florida
ZIP/Postal Code
34677
Country
United States
Facility Name
Site Reference ID/Investigator# 61217
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site Reference ID/Investigator# 61231
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Site Reference ID/Investigator# 61245
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Site Reference ID/Investigator# 61263
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Site Reference ID/Investigator# 61210
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Site Reference ID/Investigator# 61260
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472-3930
Country
United States
Facility Name
Site Reference ID/Investigator# 61244
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
Site Reference ID/Investigator# 61266
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Site Reference ID/Investigator# 61206
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Site Reference ID/Investigator# 61223
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Site Reference ID/Investigator# 61273
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Site Reference ID/Investigator# 61228
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Site Reference ID/Investigator# 61264
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Site Reference ID/Investigator# 61238
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Site Reference ID/Investigator# 61205
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Site Reference ID/Investigator# 61218
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Site Reference ID/Investigator# 61235
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Site Reference ID/Investigator# 61232
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Site Reference ID/Investigator# 61269
City
Franklin
State/Province
Wisconsin
ZIP/Postal Code
53132
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee

We'll reach out to this number within 24 hrs