Clinical trial NCT00761150: Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Low Back Pain
Keywords: Effect on sleep interference by pain
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 308
Sex: ALL
Minimum age (years): 21
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 the study was to test the efficacy of 2 tablets (twice daily) of ABT-712, compared to placebo, administered over a 4-week period in participants with moderate to severe mechanical chronic low back pain (CLBP).

Detailed description: The study used a randomized withdrawal design with an open label (OL) period prior to a double-blind (DB) period. Participants who were receiving benefit and were tolerating ABT-712 during the OL period were randomized into the DB period. Study drug was given for a total of 8 weeks, which included up to 3 weeks in OL, up to 4 weeks in DB, and a 1-week DB taper. During the OL period, all participants took increasing doses of ABT-712 until they were taking 2 tablets, twice daily. During the DB period, participants in the ABT-712 group took 2 ABT-712 tablets, twice daily throughout the 4 weeks, while participants in the placebo group took 2 placebo tablets twice daily.

Eligibility criteria: Inclusion Criteria:

* Adult male and female subjects who voluntarily sign the informed consent
* Diagnosis of CLBP of 6 months duration

Exclusion Criteria:

* Incapacitated or bedridden subjects
* Subjects with history of surgical or invasive intervention

Primary outcomes:
measure: Change From Double-blind (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)
timeFrame: Double-blind baseline to 4 weeks
Secondary outcomes:
measure: Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)
timeFrame: Double-blind baseline to 4 weeks
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Site Reference ID/Investigator# 10143
state: Arizona
city: Tempe
country: United States
facility: Site Reference ID/Investigator# 10161
state: Arizona
city: Tucson
country: United States
facility: Site Reference ID/Investigator# 10155
state: Arizona
city: Anaheim
country: United States
facility: Site Reference ID/Investigator# 10160
state: California
city: Lomita
country: United States
facility: Site Reference ID/Investigator# 10821
state: California
city: Clearwater
country: United States
facility: Site Reference ID/Investigator# 10152
state: Florida
city: DeLand
country: United States
facility: Site Reference ID/Investigator# 10157
state: Florida
city: Oldsmar
country: United States
facility: Site Reference ID/Investigator# 10142
state: Florida
city: Pembroke Pines
country: United States
facility: Site Reference ID/Investigator# 10147
state: Florida
city: Plantation
country: United States
facility: Site Reference ID/Investigator# 13821
state: Florida
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 15821
state: Illinois
city: Crestview Hills
country: United States
facility: Site Reference ID/Investigator# 10136
state: Kentucky
city: New Orleans
country: United States
facility: Site Reference ID/Investigator# 10822
state: Louisiana
city: Shreveport
country: United States
facility: Site Reference ID/Investigator# 10140
state: Louisiana
city: Brockton
country: United States
facility: Site Reference ID/Investigator# 10158
state: Massachusetts
city: Fall River
country: United States
facility: Site Reference ID/Investigator# 13601
state: Massachusetts
city: Wellesley Hills
country: United States
facility: Site Reference ID/Investigator# 10162
state: Massachusetts
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 10159
state: Nebraska
city: Las Vegas
country: United States
facility: Site Reference ID/Investigator# 10126
state: Nevada
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 10156
state: Ohio
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 10148
state: Ohio
city: Kettering
country: United States
facility: Site Reference ID/Investigator# 10151
state: Ohio
city: Marion
country: United States
facility: Site Reference ID/Investigator# 10138
state: Ohio
city: Perrysburgh
country: United States
facility: Site Reference ID/Investigator# 10150
state: Ohio
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 10141
state: Texas
city: El Paso
country: United States
facility: Site Reference ID/Investigator# 10149
state: Texas
city: Fort Worth
country: United States
facility: Site Reference ID/Investigator# 10130
state: Texas
city: Killeen
country: United States
facility: Site Reference ID/Investigator# 10163
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 13201
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 10154
state: Texas
city: Roanoke
country: United States
facility: Site Reference ID/Investigator# 10144
state: Virginia
city: Spokane
country: United States
facility: Site Reference ID/Investigator# 10113
state: Washington
Study officials:
affiliation: AbbVie
name: Pedro Quintana Diez, MD
role: STUDY_DIRECTOR
References: