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Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)

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ClinicalTrials.gov Identifier: NCT00763321
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : December 23, 2013
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description
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Brief Summary:
The primary purpose of the study is to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Drug: ABT-712 Drug: Placebo Phase 3

Detailed Description:
The study used a randomized withdrawal design with an open label (OL) period prior to a double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712 during the OL period were randomized into the DB period. Study drug was given for a total of 8 weeks, which included up to 3 weeks in OL, up to 4 weeks in DB, and a 1-week DB taper. During the OL period, all participants took increasing doses of ABT-712 until they were taking 2 tablets, twice daily. During the DB period, participants in the ABT-712 group took 2 ABT-712 tablets, twice daily throughout the 4 weeks, while participants in the placebo group took 2 placebo tablets twice daily.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label Period Followed by a Randomized, Double-blind Placebo-controlled Study of the Analgesic Efficacy of Extended-release Hydrocodone/Acetaminophen (Vicodin CR) Compared to Placebo in Subjects With Chronic Low Back Pain
Study Start Date : September 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

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 ABT-712
2 ABT-712 extended-release tablets, twice daily, for up to 3 weeks (open-label period).
 Drug: ABT-712
ABT-712 extended-release tablet
Other Names:
  • Hydrocodone and acetaminophen extended-release
  • Hydrocodone bitartrate and acetaminophen extended-release
Experimental: Double-blind ABT-712
2 ABT-712 extended-release tablets, twice daily, for 4 weeks (double-blind period).
 Drug: ABT-712
ABT-712 extended-release tablet
Other Names:
  • Hydrocodone and acetaminophen extended-release
  • Hydrocodone bitartrate and acetaminophen extended-release
Placebo Comparator: Double-blind Placebo
2 placebo tablets, twice daily, for 4 weeks (double-blind period).
 Drug: Placebo
Placebo tablet


Outcome Measures
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Primary Outcome Measures :
  1. Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS) [ Time Frame: Double-blind baseline to 4 weeks ]
    The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB 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 2-way ANCOVA model without interaction.


Secondary Outcome Measures :
  1. Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI) [ Time Frame: Double-blind baseline to 4 weeks ]
    The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant's sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult male and female subjects who voluntarily sign the informed consent
  • Diagnosis of CLBP of 6 months duration

Exclusion Criteria:

  • Incapacitated or bedridden subjects
  • Subjects with 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): NCT00763321


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: NCT00763321    
Other Study ID Numbers: M10-277
First Posted: September 30, 2008    Key Record Dates
Results First Posted: December 23, 2013
Last Update Posted: February 6, 2014
Last Verified: January 2014
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Effect on sleep interference by pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Acetaminophen
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