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Phase 2 Chronic Low Back Pain Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01364922
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : December 23, 2013
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description
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Brief Summary:
The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Drug: hydrocodone/acetaminophen extended release Drug: Placebo Phase 2

Detailed Description:
This phase 2, multicenter, double-blind (DB), placebo-controlled, randomized withdrawal study compared the analgesic efficacy and safety of hydrocodone/acetaminophen extended release to placebo in subjects with moderate to moderately severe chronic lower back pain (CLBP). Participants met pre-defined criteria at the conclusion of the open-label (OL) Titration Period to proceed to randomization into the double-blind (DB) Maintenance Period of the study. Study drug was given for a total of approximately 5 weeks, which included 2 weeks in OL, 2 weeks in DB, and a 3-day taper. During the OL period, all participants took increasing doses of hydrocodone/acetaminophen extended release until they were taking 2 tablets, twice daily. During the DB period, participants in the hydrocodone/acetaminophen extended release group took 1 hydrocodone/acetaminophen extended release tablet twice daily throughout the 2 weeks, while participants in the placebo group took 1 placebo tablet twice daily.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: Open-label Hydrocodone/Acetaminophen Extended Release
Hydrocodone/acetaminophen extended release, 2 tablets twice daily
 Drug: hydrocodone/acetaminophen extended release
Other Name: ABT-712
Experimental: Double-blind Hydrocodone/Acetaminophen Extended Release
Hydrocodone/acetaminophen extended release, 1 tablet twice daily
 Drug: hydrocodone/acetaminophen extended release
Other Name: ABT-712
Placebo Comparator: Double-blind Placebo
Placebo, 1 tablet twice daily
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS) [ Time Frame: Double-blind baseline to Day 29 ]
    The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from an ANCOVA model.


Secondary Outcome Measures :
  1. Participant's Global Assessment of Back Pain Status at Final Evaluation [ Time Frame: Double-blind baseline to Day 29 ]
    The participant's overall impression of their back pain status was obtained by having the participant answer the question "Considering all the ways your chronic low back pain affects you, how are you doing today?" on a 5-point categorical scale: very good (no symptoms and no limitation of normal activities); good (mild symptoms and no limitation of normal activities); fair (moderate symptoms and limitation of some normal activities); poor (severe symptoms and inability to carry out most normal activities); very poor (very severe symptoms which are intolerable and inability to carry out all normal activities).

  2. Participant's Global Assessment of Study Drug at Final Evaluation [ Time Frame: Double-blind baseline to Day 29 ]
    The participant's overall impression of the study drug was obtained by having the participant answer the question "How would you rate your overall response to the study medication?" on a 5-point categorical scale: excellent; very good; good; fair; poor.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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): NCT01364922


Locations
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Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
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Study Director: Pedro Quintana Diez, MD AbbVie
More Information
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Additional Information:

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Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01364922    
Other Study ID Numbers: M12-807
First Posted: June 3, 2011    Key Record Dates
Results First Posted: December 23, 2013
Last Update Posted: January 29, 2014
Last Verified: December 2013
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
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