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

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABT-652
Placebo
Naproxen
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

Eligibility Criteria

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

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

Sites / Locations

  • Site Reference ID/Investigator# 37220
  • Site Reference ID/Investigator# 37223
  • Site Reference ID/Investigator# 37215
  • Site Reference ID/Investigator# 37221
  • Site Reference ID/Investigator# 37222
  • Site Reference ID/Investigator# 35956
  • Site Reference ID/Investigator# 37053
  • Site Reference ID/Investigator# 37218
  • Site Reference ID/Investigator# 37227
  • Site Reference ID/Investigator# 37229
  • Site Reference ID/Investigator# 37209
  • Site Reference ID/Investigator# 37212
  • Site Reference ID/Investigator# 35961
  • Site Reference ID/Investigator# 37207
  • Site Reference ID/Investigator# 37217
  • Site Reference ID/Investigator# 37228
  • Site Reference ID/Investigator# 35959
  • Site Reference ID/Investigator# 37211
  • Site Reference ID/Investigator# 37214
  • Site Reference ID/Investigator# 37205
  • Site Reference ID/Investigator# 37208
  • Site Reference ID/Investigator# 37213
  • Site Reference ID/Investigator# 35953
  • Site Reference ID/Investigator# 41782
  • Site Reference ID/Investigator# 41779
  • Site Reference ID/Investigator# 41778
  • Site Reference ID/Investigator# 41785
  • Site Reference ID/Investigator# 41582
  • Site Reference ID/Investigator# 41776
  • Site Reference ID/Investigator# 41563
  • Site Reference ID/Investigator# 41566
  • Site Reference ID/Investigator# 41565
  • Site Reference ID/Investigator# 41562
  • Site Reference ID/Investigator# 41951
  • Site Reference ID/Investigator# 37183
  • Site Reference ID/Investigator# 37622
  • Site Reference ID/Investigator# 35966
  • Site Reference ID/Investigator# 37184

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

ABT-652 high dose

ABT-652 low dose

Naproxen

Placebo

Arm Description

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

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

Naproxen capsules- twice daily for 8 weeks

Placebo capsules- twice daily for 8 weeks

Outcomes

Primary Outcome Measures

24-hour average pain score measured by Visual Analog Scale
Subject reported pain intensity measured by Visual Analog Scale (0-100)

Secondary Outcome Measures

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

Full Information

First Posted
September 21, 2010
Last Updated
January 2, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
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1. Study Identification

Unique Protocol Identification Number
NCT01207115
Brief Title
A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
322 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-652 high dose
Arm Type
Experimental
Arm Description
ABT-652 capsules- twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm.
Arm Title
ABT-652 low dose
Arm Type
Experimental
Arm Description
ABT-652 capsules - twice daily for 8 weeks. The dose ABT-652 will depend on the Arm
Arm Title
Naproxen
Arm Type
Active Comparator
Arm Description
Naproxen capsules- twice daily for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules- twice daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
ABT-652
Intervention Description
ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules - twice daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Naproxen capsules - twice daily for 8 weeks
Primary Outcome Measure Information:
Title
24-hour average pain score measured by Visual Analog Scale
Description
Subject reported pain intensity measured by Visual Analog Scale (0-100)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores
Description
Self administered, patient-centered, health status questionnaire
Time Frame
8 weeks
Title
Subject's Global Assessment of Arthritis Status
Description
Subject reported assessment of arthritis status measured by Visual Analogue Scale (0-100)
Time Frame
8 weeks
Title
Brief Pain Inventory
Description
Subject reported pain intensity and intereference (scale 0-10)
Time Frame
8 weeks
Title
SF-36v2™ Health Status Survey
Description
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
Time Frame
8 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Duan, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 37220
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Site Reference ID/Investigator# 37223
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Site Reference ID/Investigator# 37215
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Site Reference ID/Investigator# 37221
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Site Reference ID/Investigator# 37222
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Site Reference ID/Investigator# 35956
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Site Reference ID/Investigator# 37053
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Site Reference ID/Investigator# 37218
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
Site Reference ID/Investigator# 37227
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Site Reference ID/Investigator# 37229
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Site Reference ID/Investigator# 37209
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Site Reference ID/Investigator# 37212
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
Site Reference ID/Investigator# 35961
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Site Reference ID/Investigator# 37207
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Site Reference ID/Investigator# 37217
City
Brooklyn Center
State/Province
Minnesota
ZIP/Postal Code
55430
Country
United States
Facility Name
Site Reference ID/Investigator# 37228
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Site Reference ID/Investigator# 35959
City
New York
State/Province
New York
ZIP/Postal Code
10004
Country
United States
Facility Name
Site Reference ID/Investigator# 37211
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Site Reference ID/Investigator# 37214
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Site Reference ID/Investigator# 37205
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Site Reference ID/Investigator# 37208
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Site Reference ID/Investigator# 37213
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209-1744
Country
United States
Facility Name
Site Reference ID/Investigator# 35953
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Site Reference ID/Investigator# 41782
City
Brisbane
ZIP/Postal Code
4102
Country
Australia
Facility Name
Site Reference ID/Investigator# 41779
City
Campsie, Sydney
ZIP/Postal Code
2194
Country
Australia
Facility Name
Site Reference ID/Investigator# 41778
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Facility Name
Site Reference ID/Investigator# 41785
City
Fitzroy
ZIP/Postal Code
VIC 3065
Country
Australia
Facility Name
Site Reference ID/Investigator# 41582
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Facility Name
Site Reference ID/Investigator# 41776
City
Malvern East
ZIP/Postal Code
3145
Country
Australia
Facility Name
Site Reference ID/Investigator# 41563
City
Montreal
ZIP/Postal Code
H2L 1S6
Country
Canada
Facility Name
Site Reference ID/Investigator# 41566
City
Newmarket
ZIP/Postal Code
L3Y 3R7
Country
Canada
Facility Name
Site Reference ID/Investigator# 41565
City
Pointe-Claire
ZIP/Postal Code
H9J 3W3
Country
Canada
Facility Name
Site Reference ID/Investigator# 41562
City
Sainte-Foy, Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Site Reference ID/Investigator# 41951
City
Santiago
Country
Chile
Facility Name
Site Reference ID/Investigator# 37183
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 37622
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 35966
City
San Juan
ZIP/Postal Code
00936-8344
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 37184
City
Trujillo Alto
ZIP/Postal Code
00976
Country
Puerto Rico

12. IPD Sharing Statement

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

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