A Study of Pain Relief in Osteoarthritis
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00298974
First received: March 2, 2006
Last updated: January 24, 2011
Last verified: January 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: hydrocodone / acetaminophen extended release Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- Pain Intensity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Arthritis Pain Intensity measured by a 100mm Visual Analog Scale (VAS)
Secondary Outcome Measures:
- Pain intensity difference (PID) from baseline to each scheduled evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- SF-36v2 Health Status Survey [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 873 |
| Study Start Date: | February 2006 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 21 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298974
Show 83 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298974
Show 83 Study Locations
Sponsors and Collaborators
Abbott
Investigators
| Study Director: | Rita Jain, M.D. | Abbott |
More Information
| Responsible Party: | Earle Lockhart,MD, Abbott |
| ClinicalTrials.gov Identifier: | NCT00298974 History of Changes |
| Other Study ID Numbers: | M04-697 |
| Study First Received: | March 2, 2006 |
| Last Updated: | January 24, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Abbott:
|
Osteoarthritis of the hip or knee |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Acetaminophen Acetaminophen, hydrocodone drug combination Hydrocodone Oxycodone 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 |
ClinicalTrials.gov processed this record on September 27, 2016