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: NCT00761150
• Other study ID #: M10-385
• Status: Completed
• Phase: Phase 3
• First received: September 25, 2008
• Last updated: January 9, 2014
• Start date: September 2008
• Est. completion date: March 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 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).

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: 308
• Est. completion date: March 2009
• Est. primary completion date: March 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# 10160	Anaheim	California
United States	Site Reference ID/Investigator# 10158	Brockton	Massachusetts
United States	Site Reference ID/Investigator# 15821	Chicago	Illinois
United States	Site Reference ID/Investigator# 10148	Cincinnati	Ohio
United States	Site Reference ID/Investigator# 10156	Cincinnati	Ohio
United States	Site Reference ID/Investigator# 10152	Clearwater	Florida
United States	Site Reference ID/Investigator# 10136	Crestview Hills	Kentucky
United States	Site Reference ID/Investigator# 10141	Dallas	Texas
United States	Site Reference ID/Investigator# 10157	DeLand	Florida
United States	Site Reference ID/Investigator# 10149	El Paso	Texas
United States	Site Reference ID/Investigator# 13601	Fall River	Massachusetts
United States	Site Reference ID/Investigator# 10130	Fort Worth	Texas
United States	Site Reference ID/Investigator# 10151	Kettering	Ohio
United States	Site Reference ID/Investigator# 10163	Killeen	Texas
United States	Site Reference ID/Investigator# 10126	Las Vegas	Nevada
United States	Site Reference ID/Investigator# 10821	Lomita	California
United States	Site Reference ID/Investigator# 10138	Marion	Ohio
United States	Site Reference ID/Investigator# 10822	New Orleans	Louisiana
United States	Site Reference ID/Investigator# 10142	Oldsmar	Florida
United States	Site Reference ID/Investigator# 10159	Omaha	Nebraska
United States	Site Reference ID/Investigator# 10147	Pembroke Pines	Florida
United States	Site Reference ID/Investigator# 10150	Perrysburgh	Ohio
United States	Site Reference ID/Investigator# 13821	Plantation	Florida
United States	Site Reference ID/Investigator# 10144	Roanoke	Virginia
United States	Site Reference ID/Investigator# 10154	San Antonio	Texas
United States	Site Reference ID/Investigator# 13201	San Antonio	Texas
United States	Site Reference ID/Investigator# 10140	Shreveport	Louisiana
United States	Site Reference ID/Investigator# 10113	Spokane	Washington
United States	Site Reference ID/Investigator# 10143	Tempe	Arizona
United States	Site Reference ID/Investigator# 10161	Tempe	Arizona
United States	Site Reference ID/Investigator# 10155	Tucson	Arizona
United States	Site Reference ID/Investigator# 10162	Wellesley Hills	Massachusetts

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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