Phase 2 Chronic Low Back Pain Study

NCT01364922 | Completed Phase 2 Results

• 1 other identifier: M12-807
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS)

  The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind 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 an ANCOVA model.

  Double-blind baseline to Day 29

Secondary Outcomes (2)

• Participant's Global Assessment of Back Pain Status at Final Evaluation

  Double-blind baseline to Day 29

• Participant's Global Assessment of Study Drug at Final Evaluation

  Double-blind baseline to Day 29

Study Arms (3)

Open-label Hydrocodone/Acetaminophen Extended Release

EXPERIMENTAL

Hydrocodone/acetaminophen extended release, 2 tablets twice daily

Drug: hydrocodone/acetaminophen extended release

Double-blind Hydrocodone/Acetaminophen Extended Release

EXPERIMENTAL

Hydrocodone/acetaminophen extended release, 1 tablet twice daily

Drug: hydrocodone/acetaminophen extended release

Double-blind Placebo

PLACEBO COMPARATOR

Placebo, 1 tablet twice daily

Drug: Placebo

Interventions

hydrocodone/acetaminophen extended release DRUG

Also known as: ABT-712

Double-blind Hydrocodone/Acetaminophen Extended Release; Open-label Hydrocodone/Acetaminophen Extended Release

Placebo DRUG

Double-blind Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects who have a diagnosis of chronic low back pain of at least 6 month duration

You may not qualify if:

• Subjects with a history of surgical or invasive intervention

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (17)

Site Reference ID/Investigator# 54875

Tucson, Arizona, 85704, United States

Location

Site Reference ID/Investigator# 54876

Anaheim, California, 92801, United States

Location

Site Reference ID/Investigator# 54877

Burbank, California, 91505, United States

Location

Site Reference ID/Investigator# 54873

Lomita, California, 90717, United States

Location

Site Reference ID/Investigator# 54874

DeLand, Florida, 32720, United States

Location

Site Reference ID/Investigator# 54866

Oldsmar, Florida, 34677, United States

Location

Site Reference ID/Investigator# 54879

Marietta, Georgia, 30060, United States

Location

Site Reference ID/Investigator# 54865

Valparaiso, Indiana, 46383, United States

Location

Site Reference ID/Investigator# 54782

Prairie Village, Kansas, 66206, United States

Location

Site Reference ID/Investigator# 54862

Pasadena, Maryland, 21122, United States

Location

Site Reference ID/Investigator# 54878

Watertown, Massachusetts, 02472-3930, United States

Location

Site Reference ID/Investigator# 54880

St Louis, Missouri, 63141, United States

Location

Site Reference ID/Investigator# 54881

Williamsville, New York, 14221, United States

Location

Site Reference ID/Investigator# 54872

Cincinnati, Ohio, 45227, United States

Location

Site Reference ID/Investigator# 54863

Marion, Ohio, 43302, United States

Location

Site Reference ID/Investigator# 54745

Killeen, Texas, 76543, United States

Location

Site Reference ID/Investigator# 54742

San Antonio, Texas, 78209-1744, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

Hydrocodone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Pedro Quintana Diez, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 3, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 29, 2014
• Results First Posted: December 23, 2013

Record last verified: 2013-12

Locations

US (17)