Phase 2 Chronic Low Back Pain Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01364922
First received: June 1, 2011
Last updated: December 23, 2013
Last verified: December 2013

June 1, 2011
December 23, 2013
June 2011
October 2011   (final data collection date for primary outcome measure)
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.
Pain Intensity Difference (PID) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Pain intensity scores measured using a 100 mm Visual Analog Scale
Complete list of historical versions of study NCT01364922 on ClinicalTrials.gov Archive Site
  • 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.
  • Subjects Global Assessment of Back Pain Status [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    5 point categorical scale
  • Subjects Global Assessment of Study Drug [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    5 point categorical scale
Not Provided
Not Provided
 
Phase 2 Chronic Low Back Pain Study
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

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Low Back Pain
  • Drug: hydrocodone/acetaminophen extended release
    Other Name: ABT-712
  • Drug: Placebo
  • Experimental: Open-label Hydrocodone/Acetaminophen Extended Release
    Hydrocodone/acetaminophen extended release, 2 tablets twice daily
    Intervention: Drug: hydrocodone/acetaminophen extended release
  • Experimental: Double-blind Hydrocodone/Acetaminophen Extended Release
    Hydrocodone/acetaminophen extended release, 1 tablet twice daily
    Intervention: Drug: hydrocodone/acetaminophen extended release
  • Placebo Comparator: Double-blind Placebo
    Placebo, 1 tablet twice daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
October 2011
October 2011   (final data collection date for primary outcome measure)

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

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01364922
M12-807
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Pedro Quintana Diez, MD AbbVie
AbbVie
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP