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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Drug: EN3324 (axomadol); Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 236
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85050
      • Matthew Doust, MD
    • Tucson, Arizona, United States, 85712
      • Visions Clinical Research
    • Tucson, Arizona, United States, 85741
      • Genova Clinical Research, Inc.
    • Tucson, Arizona, United States, 85705
      • Paradigm Clinical
    • Tuscon, Arizona, United States, 85715
      • Quality of Life Medical & Research Center
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
    • Anaheim, California, United States, 92801
      • Orange County Clinical Trials, Inc.
    • Buena Park, California, United States, 90620
      • Associated Pharmaceutical Research Center, Inc.
    • Chino, California, United States, 91710
      • Catalina Research Institute, LLC
    • Garden Grove, California, United States, 92844
      • Paradigm Clinical Research
    • La Mesa, California, United States, 91942
      • TriWest Research Associates
    • La Mesa, California, United States, 91942
      • Synergy Escondido
    • Long Beach, California, United States, 90806
      • LBCCR
    • Los Angeles, California, United States, 90024
      • Pacific Institute for Med Research
    • Los Gatos, California, United States, 95032
      • Samaritan Center for Medical Research
    • National City, California, United States, 91950
      • Synergy Research Center
    • Sacramento, California, United States, 95821
      • Northern California Research
  • Colorado
    • Denver, Colorado, United States, 80209
      • Mountain View Clinical Research
  • Florida
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research
    • Fort Myers, Florida, United States, 33912
      • Neuropsychiatric Research Center of SW Florida
    • Jacksonville, Florida, United States, 32257
      • Florida Institute of Medical Research
    • Jacksonville, Florida, United States, 32216
      • CNS Healthcare
    • Lauderhill, Florida, United States, 33319
      • Behavioral Clinical Research, Inc.
    • North Miami, Florida, United States, 33161
      • Segal Institute for Clinical Research
    • Orlando, Florida, United States, 32806
      • Compass Research
    • Orlando, Florida, United States, 32806
      • CNS Health
    • Orlando, Florida, United States, 32822
      • Altas Orthopedics & Sports Medicine
    • Plantation, Florida, United States, 33324
      • Gold Coast Research LLC.
  • Illinois
    • Chicago, Illinois, United States, 60603
      • Medex Healthcare Research, Inc.
    • Chicago, Illinois, United States, 60611
      • Center for Pain Management Rehabilitation Institute of Chicago
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Integrated Clinical Trial Services Inc.
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • International Clinical Research Institute Inc.
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • Robert Wagner, MD
    • Paducah, Kentucky, United States, 42003
      • Four Rivers Clinical Research
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
      • Beacon Clinical Research LLC
  • Michigan
    • Bingham Farms, Michigan, United States, 48025
      • Quest Research Institute
  • Missouri
    • Florissant, Missouri, United States, 63031
      • Prime Care Research Associates
    • St. Louis, Missouri, United States, 63141
      • Sundance Clinical Research
    • St. Louis, Missouri, United States, 63117
      • Medex Health Research, Inc.
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Office of Danka Micheals, MD
    • Las Vegas, Nevada, United States, 89144
      • Stephen Miller, MD
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Comprehensive Clinical Research
  • New York
    • Rochester, New York, United States, 14618
      • Finger Lakes Clinical Research
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • New Hanover Medical Research
    • Winstom-Salem, North Carolina, United States, 27103
      • The Center for Clinical Research, LLC & Carolinas Pain Institute, P.A.
  • Ohio
    • Cincinnari, Ohio, United States, 45245
      • David Schneider, MD
    • Cincinnati, Ohio, United States, 45227
      • Community Research
    • Middleburg Heights, Ohio, United States, 44130
      • North Star Medical Research, LLC
    • Toledo, Ohio, United States, 43623
      • Bone, Joint & Spine Surgeons, Inc.
    • Toledo, Ohio, United States, 43623
      • Neurology & Neruoscience Center of Ohio
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Alleghany Pain Management, PC
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • Paragon Clinical Research Inc.
    • Warwick, Rhode Island, United States, 02818
      • Omega Clinical Research
  • Texas
    • Ausitn, Texas, United States, 78756
      • Future Search Trials
    • Ausitn, Texas, United States, 78758
      • Austin Diagnostic Clinic
    • Dallas, Texas, United States, 75230
      • KRK Medical Research
    • Houston, Texas, United States, 77074
      • Clinical Trial Network
    • Houston, Texas, United States, 77074
      • Medex Healthcare Research
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; twice daily dosing
Experimental: EN3324 (axomadol)	Drug: EN3324 (axomadol); twice daily dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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]
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]

Collaborators and Investigators

• Sponsor: Grünenthal GmbH

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: December 18, 2009
• First Submitted That Met QC Criteria: January 4, 2010
• First Posted (Estimate): January 6, 2010

Study Record Updates

• Last Update Posted (Estimate): April 2, 2015
• Last Update Submitted That Met QC Criteria: March 13, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: EN3324-201