Phase 2 Chronic Low Back Pain Study

This study has been completed.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier:
First received: June 1, 2011
Last updated: December 23, 2013
Last verified: December 2013

The primary purpose of this study was 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:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Participant's Global Assessment of Back Pain Status at Final Evaluation [ Time Frame: Double-blind baseline to Day 29 ] [ Designated as safety issue: No ]
    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).

  • Participant's Global Assessment of Study Drug at Final Evaluation [ Time Frame: Double-blind baseline to Day 29 ] [ Designated as safety issue: No ]
    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.

Enrollment: 168
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: 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

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.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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 identifier: NCT01364922

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)
Study Director: Pedro Quintana Diez, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier: NCT01364922     History of Changes
Other Study ID Numbers: M12-807
Study First Received: June 1, 2011
Results First Received: November 1, 2013
Last Updated: December 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Low Back Pain
Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen, hydrocodone drug combination
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on September 16, 2014