A Study of Pain Relief in Osteoarthritis
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ClinicalTrials.gov Identifier: NCT00298974 |
Recruitment Status :
Completed
First Posted : March 6, 2006
Last Update Posted : January 25, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis | Drug: hydrocodone / acetaminophen extended release Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 873 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | May 2007 |
Actual Study Completion Date : | May 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: hydrocodone/acetaminophen extended release |
Drug: hydrocodone / acetaminophen extended release
2 tablets twice daily
Other Name: ABT-712 |
Placebo Comparator: Placebo |
Drug: Placebo
2 tablets twice daily |
- Pain Intensity [ Time Frame: 12 weeks ]Arthritis Pain Intensity measured by a 100mm Visual Analog Scale (VAS)
- 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 ]

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Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00298974

Study Director: | Rita Jain, M.D. | Abbott |
Responsible Party: | Earle Lockhart,MD, Abbott |
ClinicalTrials.gov Identifier: | NCT00298974 |
Other Study ID Numbers: |
M04-697 |
First Posted: | March 6, 2006 Key Record Dates |
Last Update Posted: | January 25, 2011 |
Last Verified: | January 2011 |
Osteoarthritis of the hip or knee |
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Acetaminophen Acetaminophen, hydrocodone drug combination Hydrocodone Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Analgesics, Opioid Narcotics Central Nervous System Depressants Antitussive Agents Respiratory System Agents Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents |