OsteoarthritisPhase 3NCT00298974
A Study of Pain Relief in Osteoarthritis
A Phase 3 study testing hydrocodone / acetaminophen extended release in people with Osteoarthritis, run by Abbott at 83 sites in United States.
Trial summary
The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR to placebo in subjects with osteoarthritis (OA) of the hip or knee. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- hydrocodone / acetaminophen extended release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 873 participants
- Where
- 83 sitesUnited States
- Study dates
- Feb 2006to May 2007
- Phase
- Phase 3
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ages 21 to 80
- If female, must be of non-child bearing potential or practicing birth control
- Has osteoarthritis of the hip or knee
- Requires therapeutic doses of medication for osteoarthritis pain
- Has sufficient pain to justify the use of around-the-clock opioids
Who cannot join
- Is associated with any currently ongoing research study, or has previously participated in a Vicodin CR study
- Is allergic to or has had a serious reaction to hydrocodone, other opioids, or acetaminophen
- Cannot discontinue pain medications, even for the short time prior to the study start
- Has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery
- Has a history of gastric bypass surgery or preexisting severe gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract
- Has a history of malnutrition or starvation
Show all 13Show fewer
- Has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day
- Has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder
- Pregnant or breastfeeding females
- Is incapacitated, bedridden or confined to a wheelchair
- Has initiated any new therapy or medication for OA within 1 month of screening
- Has had surgery, certain types of procedures, or received certain medications for osteoarthritis within a specified time frame
- Has other conditions that may cause pain, such as rheumatoid arthritis or gout
Trial locations and contacts
83 sites in 1 country.
83 sites in 1 country
United States83 sites
Site Ref # / Investigator 526
Anaheim, California, 92801
Site Ref # / Investigator 350
Austin, Texas, 78705
Site Ref # / Investigator 529
Biloxi, Mississippi, 39531
Site Ref # / Investigator 423
Birmingham, Alabama, 35235
Site Ref # / Investigator 581
Birmingham, Alabama, 35235
Site Ref # / Investigator 459
Birmingham, Alabama, 35244
Site Ref # / Investigator 560
Brockton, Massachusetts, 02301
Site Ref # / Investigator 533
Buena Park, California, 90620
Site Ref # / Investigator 525
Centerville, Ohio, 45459
Site Ref # / Investigator 454
Chesapeake, Virginia, 23320
Site Ref # / Investigator 550
Chicago, Illinois, 60611
Site Ref # / Investigator 724
Cincinnati, Ohio, 45236
Site Ref # / Investigator 521
Cincinnati, Ohio, 45242
Site Ref # / Investigator 497
Clearwater, Florida, 33756
Site Ref # / Investigator 416
Cleveland, Ohio, 44122
Site Ref # / Investigator 582
Columbus, Ohio, 43235
Site Ref # / Investigator 351
Cranston, Rhode Island, 02920
Site Ref # / Investigator 558
Dallas, Texas, 75230
Site Ref # / Investigator 417
Daytona Beach, Florida, 32117
Site Ref # / Investigator 505
DeLand, Florida, 32720
Site Ref # / Investigator 493
Duncansville, Pennsylvania, 16635
Site Ref # / Investigator 723
Eugene, Oregon, 97404
Site Ref # / Investigator 511
Evansville, Indiana, 47714
Site Ref # / Investigator 357
Fair Oaks, California, 95628
Site Ref # / Investigator 715
Fall River, Massachusetts, 02720
Site Ref # / Investigator 2544
Florissant, Missouri, 63031
Site Ref # / Investigator 466
Greenville, South Carolina, 29601
Site Ref # / Investigator 425
Greer, South Carolina, 29651
Site Ref # / Investigator 366
Jupiter, Florida, 33458-7200
Site Ref # / Investigator 709
Littleton, Colorado, 80120
Site Ref # / Investigator 388
Longwood, Florida, 32779
Site Ref # / Investigator 721
Los Angeles, California, 90095-1670
Site Ref # / Investigator 355
Louisville, Kentucky, 40213
Site Ref # / Investigator 389
Mamaroneck, New York, 10543
Site Ref # / Investigator 437
Marietta, Georgia, 30066
Site Ref # / Investigator 713
Mechanicsburg, Pennsylvania, 17055
Site Ref # / Investigator 2598
Meridian, Idaho, 83642
Site Ref # / Investigator 474
Miami, Florida, 33156
Site Ref # / Investigator 504
Milan, Tennessee, 38358
Site Ref # / Investigator 580
Mobile, Alabama, 36608
Site Ref # / Investigator 452
Monroe, North Carolina, 28112
Site Ref # / Investigator 410
New Orleans, Louisiana, 70115
Site Ref # / Investigator 528
New York, New York, 10022
Site Ref # / Investigator 523
Newburgh, Indiana, 47630
Site Ref # / Investigator 433
Ocala, Florida, 34471
Site Ref # / Investigator 420
Ocala, Florida, 34474
Site Ref # / Investigator 508
Oklahoma City, Oklahoma, 73103
Site Ref # / Investigator 359
Oldsmar, Florida, 34677
Site Ref # / Investigator 411
Omaha, Nebraska, 68134
Site Ref # / Investigator 468
Owings Mills, Maryland, 21117
Site Ref # / Investigator 418
Pasadena, Maryland, 21122
Site Ref # / Investigator 457
Pembroke Pines, Florida, 33024
Site Ref # / Investigator 479
Phoenix, Arizona, 85012
Site Ref # / Investigator 543
Phoenix, Arizona, 85014
Site Ref # / Investigator 2582
Phoenix, Arizona, 85023
Site Ref # / Investigator 434
Plantation, Florida, 33324
Site Ref # / Investigator 489
Plantation, Florida, 33324
Site Ref # / Investigator 719
Port Orange, Florida, 32127
Site Ref # / Investigator 2430
Portland, Oregon, 97201
Site Ref # / Investigator 501
Roslyn, New York, 11576
Site Ref # / Investigator 450
Salt Lake City, Utah, 84102
Site Ref # / Investigator 727
San Antonio, Texas, 78209
Site Ref # / Investigator 2420
San Antonio, Texas, 78229
Site Ref # / Investigator 476
San Antonio, Texas, 78229
Site Ref # / Investigator 439
San Diego, California, 92108
Site Ref # / Investigator 2421
Sierra Vista, Arizona, 85635
Site Ref # / Investigator 2599
Spokane, Washington, 99204
Site Ref # / Investigator 2419
St Louis, Missouri, 63141
Site Ref # / Investigator 481
St. Petersburg, Florida, 33703
Site Ref # / Investigator 2594
Tampa, Florida, 33613
Site Ref # / Investigator 453
Tempe, Arizona, 85282
Site Ref # / Investigator 584
Tucson, Arizona, 85712
Site Ref # / Investigator 393
Tucson, Arizona, 85741
Site Ref # / Investigator 435
Virginia Beach, Virginia, 23451
Site Ref # / Investigator 556
Virginia Beach, Virginia, 23454
Site Ref # / Investigator 503
Virginia Beach, Virginia, 23455
Site Ref # / Investigator 522
Wellesley Hills, Massachusetts, 02481-2106
Site Ref # / Investigator 458
West Palm Beach, Florida, 33409-3509
Site Ref # / Investigator 486
West Reading, Pennsylvania, 19611-1124
Site Ref # / Investigator 527
West Yarmouth, Massachusetts, 02673
Site Ref # / Investigator 583
Wheat Ridge, Colorado, 80033
Site Ref # / Investigator 349
Winston-Salem, North Carolina, 27103
Site Ref # / Investigator 530
Zanesville, Ohio, 43701
About this study
Official title: A Phase 3, Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy of Extended Release Hydrocodone/Acetaminophen Tablets (Vicodin CR) to Placebo in Subjects With Osteoarthritis
The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR to placebo in subjects with osteoarthritis (OA) of the hip or knee.
- Conditions
- Osteoarthritis
- Being tested
- hydrocodone / acetaminophen extended release, Placebo
- Keywords
- Osteoarthritis of the hip or knee
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocodone / acetaminophen extended releaseDrug
Also called ABT-712
2 tablets twice daily
PlaceboDrug
2 tablets twice daily
| Study group | Role | What they receive |
|---|---|---|
| hydrocodone/acetaminophen extended release | Experimental | Not described Receives: Drug: hydrocodone / acetaminophen extended release |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Arthritis Pain Intensity measured by a 100mm Visual Analog Scale (VAS)
Measured: 12 weeks
Secondary outcomes (3)
Pain intensity difference (PID) from baseline to each scheduled evaluation
Measured: 12 weeks
Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score
Measured: 12 weeks
SF-36v2 Health Status Survey
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 873 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rita Jain, M.D., Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298974
- Sponsor's protocol ID
- M04-697
- Status last verified
- Jan 2011
- First submitted
- 2 Mar 2006
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy of Extended Release Hydrocodone/Acetaminophen Tablets (Vicodin CR) to Placebo in Subjects With Osteoarthritis
- ClinicalTrials.gov ID
- NCT00298974
- Acronym / sponsor ID
- M04-697
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis of the hip or knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 873 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 6 Mar 2006 (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.
The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR to placebo in subjects with osteoarthritis (OA) of the hip or knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydrocodone/acetaminophen extended release | Experimental | Drug: hydrocodone / acetaminophen extended release |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females ages 21 to 80
- If female, must be of non-child bearing potential or practicing birth control
- Has osteoarthritis of the hip or knee
- Requires therapeutic doses of medication for osteoarthritis pain
- Has sufficient pain to justify the use of around-the-clock opioids
Key exclusion criteria (13 listed)
- Is associated with any currently ongoing research study, or has previously participated in a Vicodin CR study
- Is allergic to or has had a serious reaction to hydrocodone, other opioids, or acetaminophen
- Cannot discontinue pain medications, even for the short time prior to the study start
- Has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery
- Has a history of gastric bypass surgery or preexisting severe gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract
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 |
|---|---|---|
| hydrocodone / acetaminophen extended releaseAlso: ABT-7122 tablets twice daily | Drug | hydrocodone/acetaminophen extended release |
| Placebo2 tablets twice daily | Drug | Placebo |
Primary outcome
Pain Intensity
Time frame: 12 weeks
Arthritis Pain Intensity measured by a 100mm Visual Analog Scale (VAS)
3 secondary outcomes
Pain intensity difference (PID) from baseline to each scheduled evaluation
Time frame: 12 weeks
Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score
Time frame: 12 weeks
SF-36v2 Health Status Survey
Time frame: 12 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 25 Jan 2011.
Related trials for Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Rita Jain, M.D. study director
Abbott
83 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hydrocodone / acetaminophen extended release in people with Osteoarthritis, run by Abbott at 83 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 5 inclusion and 13 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 25 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pain Intensity (time frame: 12 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 25 Jan 2011.