Clinical trial NCT00763321: 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: 2008-09-30
Enrollment: 287
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 is 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: Huntsville
country: United States
facility: Site Reference ID/Investigator# 10044
state: Alabama
city: Burbank
country: United States
facility: Site Reference ID/Investigator# 10070
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 10050
state: California
city: Atlantis
country: United States
facility: Site Reference ID/Investigator# 10060
state: Florida
city: Hollywood
country: United States
facility: Site Reference ID/Investigator# 10069
state: Florida
city: Kissimmee
country: United States
facility: Site Reference ID/Investigator# 10045
state: Florida
city: Tampa
country: United States
facility: Site Reference ID/Investigator# 10061
state: Florida
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 10054
state: Georgia
city: Marietta
country: United States
facility: Site Reference ID/Investigator# 10071
state: Georgia
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 13604
state: Illinois
city: Evansville
country: United States
facility: Site Reference ID/Investigator# 10053
state: Indiana
city: Newburgh
country: United States
facility: Site Reference ID/Investigator# 10055
state: Indiana
city: Valparaiso
country: United States
facility: Site Reference ID/Investigator# 10043
state: Indiana
city: Prairie Village
country: United States
facility: Site Reference ID/Investigator# 10072
state: Kansas
city: Pasadena
country: United States
facility: Site Reference ID/Investigator# 10041
state: Maryland
city: Springfield
country: United States
facility: Site Reference ID/Investigator# 10049
state: Massachusetts
city: Biloxi
country: United States
facility: Site Reference ID/Investigator# 10062
state: Mississippi
city: Florissant
country: United States
facility: Site Reference ID/Investigator# 10066
state: Missouri
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 10073
state: Missouri
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 10056
state: Nebraska
city: Williamsville
country: United States
facility: Site Reference ID/Investigator# 10075
state: New York
city: Winston-Salem
country: United States
facility: Site Reference ID/Investigator# 10065
state: North Carolina
city: Fargo
country: United States
facility: Site Reference ID/Investigator# 10067
state: North Dakota
city: Oklahoma City
country: United States
facility: Site Reference ID/Investigator# 10047
state: Oklahoma
city: Altoona
country: United States
facility: Site Reference ID/Investigator# 10052
state: Pennsylvania
city: Bridgeville
country: United States
facility: Site Reference ID/Investigator# 10042
state: Pennsylvania
city: Greer
country: United States
facility: Site Reference ID/Investigator# 10063
state: South Carolina
city: Austin
country: United States
facility: Site Reference ID/Investigator# 10046
state: Texas
city: Austin
country: United States
facility: Site Reference ID/Investigator# 10058
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 10059
state: Texas
city: Chesapeake
country: United States
facility: Site Reference ID/Investigator# 10048
state: Virginia
Study officials:
affiliation: AbbVie
name: Pedro Quintana Diez, MD
role: STUDY_DIRECTOR
References: