Phase 2 Chronic Low Back Pain Study

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364922
• Other study ID #: M12-807
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2011
• Last updated: December 23, 2013
• Start date: June 2011
• Est. completion date: October 2011

Study information

• Verified date: December 2013
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Drug:
• hydrocodone/acetaminophen extended release

• Placebo

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 54876	Anaheim	California
United States	Site Reference ID/Investigator# 54877	Burbank	California
United States	Site Reference ID/Investigator# 54872	Cincinnati	Ohio
United States	Site Reference ID/Investigator# 54874	DeLand	Florida
United States	Site Reference ID/Investigator# 54745	Killeen	Texas
United States	Site Reference ID/Investigator# 54873	Lomita	California
United States	Site Reference ID/Investigator# 54879	Marietta	Georgia
United States	Site Reference ID/Investigator# 54863	Marion	Ohio
United States	Site Reference ID/Investigator# 54866	Oldsmar	Florida
United States	Site Reference ID/Investigator# 54862	Pasadena	Maryland
United States	Site Reference ID/Investigator# 54782	Prairie Village	Kansas
United States	Site Reference ID/Investigator# 54742	San Antonio	Texas
United States	Site Reference ID/Investigator# 54880	St. Louis	Missouri
United States	Site Reference ID/Investigator# 54875	Tucson	Arizona
United States	Site Reference ID/Investigator# 54865	Valparaiso	Indiana
United States	Site Reference ID/Investigator# 54878	Watertown	Massachusetts
United States	Site Reference ID/Investigator# 54881	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)	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.	Double-blind baseline to Day 29	No
Secondary	Participant's Global Assessment of Back Pain Status at Final Evaluation	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).	Double-blind baseline to Day 29	No
Secondary	Participant's Global Assessment of Study Drug at Final Evaluation	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.	Double-blind baseline to Day 29	No

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