Phase 2 Chronic Low Back Pain Study

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AbbVie ( AbbVie (prior sponsor, Abbott) )

ClinicalTrials.gov Identifier:

NCT01364922

First received: June 1, 2011

Last updated: January 2, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 1, 2011

Last Updated Date

January 2, 2013

Start Date ^ICMJE

June 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pain Intensity Difference (PID) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Pain intensity scores measured using a 100 mm Visual Analog Scale

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01364922 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Subjects Global Assessment of Back Pain Status [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
5 point categorical scale
Subjects Global Assessment of Study Drug [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
5 point categorical scale

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Phase 2 Chronic Low Back Pain Study

Official Title ^ICMJE

A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of Hydrocodone/Acetaminophen Extended Release Compared to Placebo in Subjects With Chronic Low Back Pain

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Low Back Pain

Intervention ^ICMJE

Drug: hydrocodone / acetaminophen extended release
Drug: Placebo

Study Arm (s)

Experimental: hydrocodone / acetaminophen extended release
1 tablet twice daily

Intervention: Drug: hydrocodone / acetaminophen extended release
Placebo Comparator: Placebo
1 tablet twice daily

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

167

Completion Date

October 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Subjects with a history of surgical or invasive intervention

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01364922

Other Study ID Numbers ^ICMJE

M12-807

Has Data Monitoring Committee

Responsible Party

AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Sponsor ^ICMJE

AbbVie (prior sponsor, Abbott)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Cheryl Renz, MD

AbbVie

Information Provided By

AbbVie

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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