Clinical trial NCT01364922: Phase 2 Chronic Low Back Pain Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Low Back Pain
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
timeFrame: Double-blind baseline to Day 29
Secondary outcomes:
measure: Participant's Global Assessment of Back Pain Status at Final Evaluation
timeFrame: Double-blind baseline to Day 29
measure: Participant's Global Assessment of Study Drug at Final Evaluation
timeFrame: Double-blind baseline to Day 29
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Site Reference ID/Investigator# 54875
state: Arizona
city: Anaheim
country: United States
facility: Site Reference ID/Investigator# 54876
state: California
city: Burbank
country: United States
facility: Site Reference ID/Investigator# 54877
state: California
city: Lomita
country: United States
facility: Site Reference ID/Investigator# 54873
state: California
city: DeLand
country: United States
facility: Site Reference ID/Investigator# 54874
state: Florida
city: Oldsmar
country: United States
facility: Site Reference ID/Investigator# 54866
state: Florida
city: Marietta
country: United States
facility: Site Reference ID/Investigator# 54879
state: Georgia
city: Valparaiso
country: United States
facility: Site Reference ID/Investigator# 54865
state: Indiana
city: Prairie Village
country: United States
facility: Site Reference ID/Investigator# 54782
state: Kansas
city: Pasadena
country: United States
facility: Site Reference ID/Investigator# 54862
state: Maryland
city: Watertown
country: United States
facility: Site Reference ID/Investigator# 54878
state: Massachusetts
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 54880
state: Missouri
city: Williamsville
country: United States
facility: Site Reference ID/Investigator# 54881
state: New York
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 54872
state: Ohio
city: Marion
country: United States
facility: Site Reference ID/Investigator# 54863
state: Ohio
city: Killeen
country: United States
facility: Site Reference ID/Investigator# 54745
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 54742
state: Texas
Study officials:
affiliation: AbbVie
name: Pedro Quintana Diez, MD
role: STUDY_DIRECTOR
References: