Osteoarthritis of the KneePhase 2NCT01444365
A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee
A Phase 2 study testing ABT-652 NSAID in people with Osteoarthritis of the Knee, run by AbbVie (prior sponsor, Abbott) at 31 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- ABT-652 NSAID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 31 sitesUnited States
- Study dates
- Oct 2011to Apr 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Site Reference ID/Investigator# 61257
Anaheim, California, 92801
Site Reference ID/Investigator# 61205
Beaumont, Texas, 77701
Site Reference ID/Investigator# 61210
Brockton, Massachusetts, 02301
Site Reference ID/Investigator# 61218
Bryan, Texas, 77802
Site Reference ID/Investigator# 61273
Cincinnati, Ohio, 45245
Site Reference ID/Investigator# 61234
DeLand, Florida, 32720
Site Reference ID/Investigator# 61232
Draper, Utah, 84020
Site Reference ID/Investigator# 61238
Duncansville, Pennsylvania, 16635
Site Reference ID/Investigator# 61244
Florissant, Missouri, 63031
Site Reference ID/Investigator# 61269
Franklin, Wisconsin, 53132
Site Reference ID/Investigator# 61246
Fresno, California, 93726
Site Reference ID/Investigator# 61242
La Mesa, California, 91942
Site Reference ID/Investigator# 61204
Long Beach, California, 90806
Site Reference ID/Investigator# 61263
Marietta, Georgia, 30060
Site Reference ID/Investigator# 61265
Milford, Connecticut, 06460
Site Reference ID/Investigator# 61258
North Hollywood, California, 91606
Site Reference ID/Investigator# 61213
Ocala, Florida, 34471
Site Reference ID/Investigator# 61228
Oklahoma City, Oklahoma, 73109
Site Reference ID/Investigator# 61211
Oldsmar, Florida, 34677
Site Reference ID/Investigator# 61206
Omaha, Nebraska, 68134
Site Reference ID/Investigator# 61217
Orlando, Florida, 32806
Site Reference ID/Investigator# 61226
Phoenix, Arizona, 85023
Site Reference ID/Investigator# 61221
Phoenix, Arizona, 85032
Site Reference ID/Investigator# 61231
Plantation, Florida, 33317
Site Reference ID/Investigator# 61264
Portland, Oregon, 97239
Site Reference ID/Investigator# 61223
Salisbury, North Carolina, 28144
Site Reference ID/Investigator# 61235
San Antonio, Texas, 78209
Site Reference ID/Investigator# 61266
St Louis, Missouri, 63141
Site Reference ID/Investigator# 61245
Tampa, Florida, 33603
Site Reference ID/Investigator# 61241
Tucson, Arizona, 85704
Site Reference ID/Investigator# 61260
Watertown, Massachusetts, 02472-3930
About this study
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
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.
Read the 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.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- ABT-652 NSAID, Placebo NSAID
- Keywords
- Osteoarthritis of the knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-652 NSAIDDrug
ABT-652 capsules - 2 ABT-652 capsules twice daily (add-on) NSAID- as prescribed
Placebo NSAIDDrug
Placebo - 2 placebo capsules twice daily NSAID- as prescribed
| Study group | Role | What they receive |
|---|---|---|
| ABT-652 NSAID | Experimental | ABT-652 capsules -2 ABT-652 capsules twice daily (add-on) NSAID - as prescribed Receives: Drug: ABT-652 NSAID |
| Placebo NSAID | Placebo comparator | Placebo - 2 placebo capsules twice daily NSAID - as prescribed Receives: Drug: Placebo NSAID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's Assessment of Arthritis Pain Intensity
Subject reported 24-hour average pain score measured by Visual Analogue Scale
Measured: 6 weeks
Secondary outcomes (3)
Western Ontario and McMaster (WOMAC™ ) Osteoarthritis Index
Self administered, patient-centered, health status questionnaire
Measured: 6 weeks
Subject's Global Assessment of Arthritis Status
Subject reported pain intensity measured by Visual Analog Scale
Measured: 6 weeks
Cognitive Functioning in Patients with Chronic Pain
Subject reported assessment of cognitive functioning
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfram Nothaft, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444365
- Sponsor's protocol ID
- M13-237
- Status last verified
- May 2013
- First submitted
- 28 Sep 2011
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01444365
- Acronym / sponsor ID
- M13-237
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis of the knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 30 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABT-652 NSAID | Experimental | Drug: ABT-652 NSAIDABT-652 capsules -2 ABT-652 capsules twice daily (add-on) NSAID - as prescribed |
| Placebo NSAID | Placebo comparator | Drug: Placebo NSAIDPlacebo - 2 placebo capsules twice daily NSAID - as prescribed |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABT-652 NSAIDABT-652 capsules - 2 ABT-652 capsules twice daily (add-on) NSAID- as prescribed | Drug | ABT-652 NSAID |
| Placebo NSAIDPlacebo - 2 placebo capsules twice daily NSAID- as prescribed | Drug | Placebo NSAID |
Primary outcome
Subject's Assessment of Arthritis Pain Intensity
Time frame: 6 weeks
Subject reported 24-hour average pain score measured by Visual Analogue Scale
3 secondary outcomes
Western Ontario and McMaster (WOMAC™ ) Osteoarthritis Index
Time frame: 6 weeks
Subject's Global Assessment of Arthritis Status
Time frame: 6 weeks
Cognitive Functioning in Patients with Chronic Pain
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfram Nothaft, MD study director
AbbVie
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-652 NSAID in people with Osteoarthritis of the Knee, run by AbbVie (prior sponsor, Abbott) at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject's Assessment of Arthritis Pain Intensity (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2013.