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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).

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 2, 2013
Last verified: January 2013
History of Changes
  Purpose

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 subjects with mechanical chronic low back pain.


Condition Intervention Phase
Chronic Low Back Pain
 Drug: ABT-712 (Hydrocodone/acetaminophen extended release)
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:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Visual Analog Scale (VAS) for pain intensity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Mean pain intensity difference from the Double-blind randomization baseline to each subjects final assessment of Chronic Lower Back Pain (CLBP) pain intensity VAS


Secondary Outcome Measures:
  • Chronic Pain Sleep Inventory (CPSI) [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: Yes ]
    Subject's evaluation of their back pain and the effect of pain on their sleep


Enrollment: 310
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
Active Comparator: A
ABT-712 15/500 mg
 Drug: ABT-712 (Hydrocodone/acetaminophen extended release)
Daily for 8 weeks
Placebo Comparator: B
ABT-712 placebo
 Drug: Placebo
Daily for 5 weeks

  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 6 months duration.

Exclusion Criteria

  • Incapacitated or bedridden subjects.
  • Subjects with history of surgical or invasive intervention.
  Contacts and Locations
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: Andrea Best, DO AbbVie
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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
Last Updated: January 2, 2013
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
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 19, 2013