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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00761150
First received: September 25, 2008
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

The primary purpose of the study was 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 Intervention Phase
Chronic Low Back Pain
Drug: ABT-712
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI) [ Time Frame: Double-blind baseline to 4 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 308
Study Start Date: September 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT00761150

  Show 32 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Pedro Quintana Diez, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00761150     History of Changes
Other Study ID Numbers: M10-385
Study First Received: September 25, 2008
Results First Received: November 1, 2013
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Effect on sleep interference by pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Acetaminophen
Hydrocodone
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Antipyretics
Antitussive Agents
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014