Phase 2 Chronic Low Back Pain Study
This study has been completed.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01364922
First received: June 1, 2011
Last updated: January 2, 2013
Last verified: January 2013
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Purpose
The primary purpose of this study is to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Low Back Pain |
Drug: hydrocodone / acetaminophen extended release Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of Hydrocodone/Acetaminophen Extended Release Compared to Placebo in Subjects With Chronic Low Back Pain |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Pain Intensity Difference (PID) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Pain intensity scores measured using a 100 mm Visual Analog Scale
Secondary Outcome Measures:
- Subjects Global Assessment of Back Pain Status [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]5 point categorical scale
- Subjects Global Assessment of Study Drug [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]5 point categorical scale
| Enrollment: | 167 |
| Study Start Date: | June 2011 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: hydrocodone / acetaminophen extended release
1 tablet twice daily
|
Drug: hydrocodone / acetaminophen extended release |
|
Placebo Comparator: Placebo
1 tablet twice daily
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult subjects who have a diagnosis of chronic low back pain of at least 6 month duration
Exclusion Criteria:
- Subjects with a history of surgical or invasive intervention
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364922
Locations
| United States, Arizona | |
| Site Reference ID/Investigator# 54875 | |
| Tucson, Arizona, United States, 85704 | |
| United States, California | |
| Site Reference ID/Investigator# 54876 | |
| Anaheim, California, United States, 92801 | |
| Site Reference ID/Investigator# 54877 | |
| Burbank, California, United States, 91505 | |
| Site Reference ID/Investigator# 54873 | |
| Lomita, California, United States, 90717 | |
| United States, Florida | |
| Site Reference ID/Investigator# 54874 | |
| DeLand, Florida, United States, 32720 | |
| Site Reference ID/Investigator# 54866 | |
| Oldsmar, Florida, United States, 34677 | |
| United States, Georgia | |
| Site Reference ID/Investigator# 54879 | |
| Marietta, Georgia, United States, 30060 | |
| United States, Indiana | |
| Site Reference ID/Investigator# 54865 | |
| Valparaiso, Indiana, United States, 46383 | |
| United States, Kansas | |
| Site Reference ID/Investigator# 54782 | |
| Prairie Village, Kansas, United States, 66206 | |
| United States, Maryland | |
| Site Reference ID/Investigator# 54862 | |
| Pasadena, Maryland, United States, 21122 | |
| United States, Massachusetts | |
| Site Reference ID/Investigator# 54878 | |
| Watertown, Massachusetts, United States, 02472-3930 | |
| United States, Missouri | |
| Site Reference ID/Investigator# 54880 | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New York | |
| Site Reference ID/Investigator# 54881 | |
| Williamsville, New York, United States, 14221 | |
| United States, Ohio | |
| Site Reference ID/Investigator# 54872 | |
| Cincinnati, Ohio, United States, 45227 | |
| Site Reference ID/Investigator# 54863 | |
| Marion, Ohio, United States, 43302 | |
| United States, Texas | |
| Site Reference ID/Investigator# 54745 | |
| Killeen, Texas, United States, 76543 | |
| Site Reference ID/Investigator# 54742 | |
| San Antonio, Texas, United States, 78209-1744 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Cheryl Renz, MD | AbbVie |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01364922 History of Changes |
| Other Study ID Numbers: | M12-807 |
| Study First Received: | June 1, 2011 |
| Last Updated: | January 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Acetaminophen Acetaminophen, hydrocodone drug combination Hydrocodone Oxycodone Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics, Opioid Central Nervous System Depressants Antitussive Agents Respiratory System Agents Narcotics Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013