Study to Evaluate the Safety and Efficacy of ABT-712 in Subjects With Moderate to Severe Chronic Low Back Pain (CLBP)

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763321
• Other study ID #: M10-277
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2008
• Last updated: January 8, 2014
• Start date: September 2008
• Est. completion date: April 2009

Study information

• Verified date: January 2014
• 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• ABT-712
ABT-712 extended-release tablet
• Placebo
Placebo tablet

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 10052	Altoona	Pennsylvania
United States	Site Reference ID/Investigator# 10054	Atlanta	Georgia
United States	Site Reference ID/Investigator# 10060	Atlantis	Florida
United States	Site Reference ID/Investigator# 10046	Austin	Texas
United States	Site Reference ID/Investigator# 10058	Austin	Texas
United States	Site Reference ID/Investigator# 10062	Biloxi	Mississippi
United States	Site Reference ID/Investigator# 10042	Bridgeville	Pennsylvania
United States	Site Reference ID/Investigator# 10070	Burbank	California
United States	Site Reference ID/Investigator# 10048	Chesapeake	Virginia
United States	Site Reference ID/Investigator# 13604	Chicago	Illinois
United States	Site Reference ID/Investigator# 10059	Dallas	Texas
United States	Site Reference ID/Investigator# 10053	Evansville	Indiana
United States	Site Reference ID/Investigator# 10067	Fargo	North Dakota
United States	Site Reference ID/Investigator# 10066	Florissant	Missouri
United States	Site Reference ID/Investigator# 10063	Greer	South Carolina
United States	Site Reference ID/Investigator# 10069	Hollywood	Florida
United States	Site Reference ID/Investigator# 10044	Huntsville	Alabama
United States	Site Reference ID/Investigator# 10045	Kissimmee	Florida
United States	Site Reference ID/Investigator# 10071	Marietta	Georgia
United States	Site Reference ID/Investigator# 10055	Newburgh	Indiana
United States	Site Reference ID/Investigator# 10047	Oklahoma City	Oklahoma
United States	Site Reference ID/Investigator# 10056	Omaha	Nebraska
United States	Site Reference ID/Investigator# 10041	Pasadena	Maryland
United States	Site Reference ID/Investigator# 10072	Prairie Village	Kansas
United States	Site Reference ID/Investigator# 10050	San Diego	California
United States	Site Reference ID/Investigator# 10049	Springfield	Massachusetts
United States	Site Reference ID/Investigator# 10073	St. Louis	Missouri
United States	Site Reference ID/Investigator# 10061	Tampa	Florida
United States	Site Reference ID/Investigator# 10043	Valparaiso	Indiana
United States	Site Reference ID/Investigator# 10075	Williamsville	New York
United States	Site Reference ID/Investigator# 10065	Winston-Salem	North Carolina

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 (DB) Baseline to Final Assessment in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)	The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB 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 2-way ANCOVA model without interaction.	Double-blind baseline to 4 weeks	No
Secondary	Change From Double-blind (DB) Baseline to Final Assessment in Chronic Pain Sleep Inventory (CPSI)	The change from the DB randomization baseline (DB baseline: the last assessment before first dose in the DB period) to the final assessment of the impact of pain on the participant's sleep. The CPSI utilizes a 100 mm VAS scale for questions of how often the participant had trouble falling asleep because of pain, needed sleeping medication, was awakened by pain during the night, and was awakened by pain in the morning (0 mm = Never and 100 mm = Always); and for rating the overall quality of sleep (0 mm = Very Poor and 100 mm = Excellent). Least squares means and standard errors from 2-way ANCOVA model without interaction.	Double-blind baseline to 4 weeks	No

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