Osteoarthritis of the KneePhase 2NCT01207115
A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee
A Phase 2 study testing ABT-652 and Naproxen in people with Osteoarthritis of the Knee, run by AbbVie (prior sponsor, Abbott) at 38 sites in 5 countries.
Trial 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. 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 and Naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 322 participants
- Where
- 38 sitesin 5 countries
- Study dates
- Sep 2010to May 2011
- 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 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.
Who cannot join
- 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 locations and contacts
38 sites in 5 countries.
38 sites in 5 countries
United States23 sites
Site Reference ID/Investigator# 37221
Anaheim, California, 92801
Site Reference ID/Investigator# 37208
Austin, Texas, 78705
Site Reference ID/Investigator# 37229
Boynton Beach, Florida, 33472
Site Reference ID/Investigator# 37217
Brooklyn Center, Minnesota, 55430
Site Reference ID/Investigator# 37222
Burbank, California, 91505
Site Reference ID/Investigator# 37220
Chandler, Arizona, 85224
Site Reference ID/Investigator# 35956
Chino, California, 91710
Site Reference ID/Investigator# 37214
Duncansville, Pennsylvania, 16635
Site Reference ID/Investigator# 37053
La Mesa, California, 91942
Site Reference ID/Investigator# 37218
Lomita, California, 90717
Site Reference ID/Investigator# 37227
Milford, Connecticut, 06460
Site Reference ID/Investigator# 35959
New York, New York, 10004
Site Reference ID/Investigator# 37209
Ocala, Florida, 34471
Site Reference ID/Investigator# 37212
Plantation, Florida, 33317
Site Reference ID/Investigator# 35953
Richmond, Virginia, 23294
Site Reference ID/Investigator# 37211
Salisbury, North Carolina, 28144
Site Reference ID/Investigator# 37213
San Antonio, Texas, 78209-1744
Site Reference ID/Investigator# 35961
South Miami, Florida, 33143
Site Reference ID/Investigator# 37228
St Louis, Missouri, 63141
Site Reference ID/Investigator# 37223
Tempe, Arizona, 85282
Site Reference ID/Investigator# 37215
Tucson, Arizona, 85704
Site Reference ID/Investigator# 37207
Valparaiso, Indiana, 46383
Site Reference ID/Investigator# 37205
Wyomissing, Pennsylvania, 19610
Australia6 sites
Site Reference ID/Investigator# 41782
Brisbane, 4102
Site Reference ID/Investigator# 41779
Campsie, Sydney, 2194
Site Reference ID/Investigator# 41778
Clayton, 3168
Site Reference ID/Investigator# 41785
Fitzroy, VIC 3065
Site Reference ID/Investigator# 41582
Kogarah, 2217
Site Reference ID/Investigator# 41776
Malvern East, 3145
Canada4 sites
Site Reference ID/Investigator# 41563
Montreal, H2L 1S6
Site Reference ID/Investigator# 41566
Newmarket, L3Y 3R7
Site Reference ID/Investigator# 41565
Pointe-Claire, H9J 3W3
Site Reference ID/Investigator# 41562
Sainte-Foy, Quebec, G1W 4R4
Puerto Rico4 sites
Site Reference ID/Investigator# 37183
Caguas, 00725
Site Reference ID/Investigator# 37622
Ponce, 00716
Site Reference ID/Investigator# 35966
San Juan, 00936-8344
Site Reference ID/Investigator# 37184
Trujillo Alto, 00976
About this study
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
To compare the analgesic efficacy and safety of ABT-652 administered twice daily (BID) to placebo in subjects with osteoarthritis (OA) of the knee.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- ABT-652, Placebo, Naproxen
- 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-652Drug
ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm
PlaceboDrug
Placebo capsules - twice daily for 8 weeks
NaproxenDrug
Naproxen capsules - twice daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| ABT-652 high dose | Experimental | ABT-652 capsules- twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm. Receives: Drug: ABT-652 |
| ABT-652 low dose | Experimental | ABT-652 capsules - twice daily for 8 weeks. The dose ABT-652 will depend on the Arm Receives: Drug: ABT-652 |
| Naproxen | Active comparator | Naproxen capsules- twice daily for 8 weeks Receives: Drug: Naproxen |
| Placebo | Placebo comparator | Placebo capsules- twice daily for 8 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour average pain score measured by Visual Analog Scale
Subject reported pain intensity measured by Visual Analog Scale (0-100)
Measured: 8 weeks
Secondary outcomes (4)
Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores
Self administered, patient-centered, health status questionnaire
Measured: 8 weeks
Subject's Global Assessment of Arthritis Status
Subject reported assessment of arthritis status measured by Visual Analogue Scale (0-100)
Measured: 8 weeks
Brief Pain Inventory
Subject reported pain intensity and intereference (scale 0-10)
Measured: 8 weeks
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionMay 2011
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rachel Duan, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207115
- Sponsor's protocol ID
- M10-889
- Status last verified
- Jan 2013
- First submitted
- 21 Sep 2010
- Last updated
- 7 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01207115
- Acronym / sponsor ID
- M10-889
- Conditions
- Osteoarthritis of the Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 22 Sep 2010 (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 compare the analgesic efficacy and safety of ABT-652 administered twice daily (BID) to placebo in subjects with osteoarthritis (OA) of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ABT-652 high dose | Experimental | Drug: ABT-652ABT-652 capsules- twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm. |
| ABT-652 low dose | Experimental | Drug: ABT-652ABT-652 capsules - twice daily for 8 weeks. The dose ABT-652 will depend on the Arm |
| Naproxen | Active comparator | Drug: NaproxenNaproxen capsules- twice daily for 8 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsules- twice daily for 8 weeks |
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 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.
Key exclusion criteria (5 listed)
- 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
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-652ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm | Drug | ABT-652 high dose, ABT-652 low dose |
| PlaceboPlacebo capsules - twice daily for 8 weeks | Drug | Placebo |
| NaproxenNaproxen capsules - twice daily for 8 weeks | Drug | Naproxen |
Primary outcome
24-hour average pain score measured by Visual Analog Scale
Time frame: 8 weeks
Subject reported pain intensity measured by Visual Analog Scale (0-100)
4 secondary outcomes
Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores
Time frame: 8 weeks
Subject's Global Assessment of Arthritis Status
Time frame: 8 weeks
Brief Pain Inventory
Time frame: 8 weeks
SF-36v2™ Health Status Survey
Time frame: 8 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 7 Jan 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.
Rachel Duan, MD study director
AbbVie
38 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-652 and Naproxen in people with Osteoarthritis of the Knee, run by AbbVie (prior sponsor, Abbott) at 38 sites in 5 countries.
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 5 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 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Australia, Canada, Puerto Rico, Chile. 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?
24-hour average pain score measured by Visual Analog Scale (time frame: 8 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 7 Jan 2013.