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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01207115




Registration number
NCT01207115
Ethics application status
Date submitted
21/09/2010
Date registered
22/09/2010
Date last updated
7/01/2013

Titles & IDs
Public title
A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee
Scientific 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
Secondary ID [1] 0 0
M10-889
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABT-652
Treatment: Drugs - Placebo
Treatment: Drugs - Naproxen

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

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

Active comparator: Naproxen - Naproxen capsules- twice daily for 8 weeks

Placebo comparator: Placebo - Placebo capsules- twice daily for 8 weeks


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

Treatment: Drugs: Placebo
Placebo capsules - twice daily for 8 weeks

Treatment: Drugs: Naproxen
Naproxen capsules - twice daily for 8 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
24-hour average pain score measured by Visual Analog Scale
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Subject's Global Assessment of Arthritis Status
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Brief Pain Inventory
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
SF-36v2™ Health Status Survey
Timepoint [4] 0 0
8 weeks

Eligibility
Key inclusion 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.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
322
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 41782 - Brisbane
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 41779 - Campsie, Sydney
Recruitment hospital [3] 0 0
Site Reference ID/Investigator# 41778 - Clayton
Recruitment hospital [4] 0 0
Site Reference ID/Investigator# 41785 - Fitzroy
Recruitment hospital [5] 0 0
Site Reference ID/Investigator# 41582 - Kogarah
Recruitment hospital [6] 0 0
Site Reference ID/Investigator# 41776 - Malvern East
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
2194 - Campsie, Sydney
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
VIC 3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
2217 - Kogarah
Recruitment postcode(s) [6] 0 0
3145 - Malvern East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
Canada
State/province [13] 0 0
Montreal
Country [14] 0 0
Canada
State/province [14] 0 0
Newmarket
Country [15] 0 0
Canada
State/province [15] 0 0
Pointe-Claire
Country [16] 0 0
Canada
State/province [16] 0 0
Sainte-Foy, Quebec
Country [17] 0 0
Chile
State/province [17] 0 0
Santiago
Country [18] 0 0
Puerto Rico
State/province [18] 0 0
Caguas
Country [19] 0 0
Puerto Rico
State/province [19] 0 0
Ponce
Country [20] 0 0
Puerto Rico
State/province [20] 0 0
San Juan
Country [21] 0 0
Puerto Rico
State/province [21] 0 0
Trujillo Alto

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01207115
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rachel Duan, MD
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01207115