Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain

Phase 2

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Drug: EN3324 (axomadol); Drug: Placebo

• Registration Number: NCT01043263
• Lead Sponsor: Grünenthal GmbH

Brief Summary

The purpose of this study is to determine the efficacy and safety of EN3324 (axomadol) in subjects with moderate to severe chronic low back pain

Detailed Description

A phase IIB, randomized, double-blind, two-arm, multi-center, placebo-controlled, study to assess the efficacy and safety of EN3324 (axomadol) in subjects with moderate to severe chronic low back pain

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-18
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Disposition First Submitted: 2012-08-15
• Disposition First Submitted QC: 2012-09-02
• Disposition First Posted: 2012-09-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-13
• Last Update Posted: 2015-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

• 18 years of age or older
• Are females who are participating abstinence or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year.
• Have been on an unchanged regimen of analgesic medication for chronic low back pain on a daily basis for at least 3 months prior to screening; subjects taking opioids must not exceed total daily doses of 90mg oral morphine equivalent
• Have a history of moderate to severe CLBP

Exclusion Criteria

• Have evidence of or a history of alcohol and/or drug abuse
• Have pain secondary to a confirmed or suspected neoplasm
• Intend to alter their physical therapy regimen during the study. Subjects who begin or end physical therapy (either home exercises or formal therapy sessions) 2 weeks prior to screening or during the study period will be excluded from the study
• Have a history or physical examination finding, which may confound pain-related data (e.g., fibromyalgia, radiculopathy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EN3324 (axomadol)	EN3324 (axomadol)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.	Change from baseline [Day 0] to final visit [Day 112]

Secondary Outcome Measures

Name	Time	Method
To evaluate patient reported outcomes of EN3324 (axomadol) in subjects with moderate to severe CLBP.	Change from baseline [Day 0] to final visit [Day 112]
To evaluate the safety, tolerability and efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.	Change from baseline [Day 0] to final visit [Day 112]

Trial Locations

Locations (59)

Matthew Doust, MD; 🇺🇸 Phoenix, Arizona, United States

Paradigm Clinical; 🇺🇸 Tucson, Arizona, United States

Visions Clinical Research; 🇺🇸 Tucson, Arizona, United States

Genova Clinical Research, Inc.; 🇺🇸 Tucson, Arizona, United States

Quality of Life Medical & Research Center; 🇺🇸 Tuscon, Arizona, United States

Advanced Clinical Research Institute; 🇺🇸 Anaheim, California, United States

Orange County Clinical Trials, Inc.; 🇺🇸 Anaheim, California, United States

Associated Pharmaceutical Research Center, Inc.; 🇺🇸 Buena Park, California, United States

Catalina Research Institute, LLC; 🇺🇸 Chino, California, United States

Paradigm Clinical Research; 🇺🇸 Garden Grove, California, United States

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