search
Back to results

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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
EN3324 (axomadol)
Placebo
Sponsored by
Grünenthal GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Matthew Doust, MD
  • Paradigm Clinical
  • Visions Clinical Research
  • Genova Clinical Research, Inc.
  • Quality of Life Medical & Research Center
  • Advanced Clinical Research Institute
  • Orange County Clinical Trials, Inc.
  • Associated Pharmaceutical Research Center, Inc.
  • Catalina Research Institute, LLC
  • Paradigm Clinical Research
  • Synergy Escondido
  • Triwest Research Associates
  • LBCCR
  • Pacific Institute for Med Research
  • Samaritan Center for Medical Research
  • Synergy Research Center
  • Northern California Research
  • Mountain View Clinical Research
  • Avail Clinical Research
  • Neuropsychiatric Research Center of SW Florida
  • CNS Healthcare
  • Florida Institute of Medical Research
  • Behavioral Clinical Research, Inc.
  • Segal Institute for Clinical Research
  • CNS Health
  • Compass Research
  • Altas Orthopedics & Sports Medicine
  • Gold Coast Research LLC.
  • Medex Healthcare Research, Inc.
  • Center for Pain Management Rehabilitation Institute of Chicago
  • Integrated Clinical Trial Services Inc.
  • International Clinical Research Institute Inc.
  • Robert Wagner, MD
  • Four Rivers Clinical Research
  • Beacon Clinical Research LLC
  • Quest Research Institute
  • Prime Care Research Associates
  • Medex Health Research, Inc.
  • Sundance Clinical Research
  • Office of Danka Micheals, MD
  • Stephen Miller, MD
  • Comprehensive Clinical Research
  • Finger Lakes Clinical Research
  • New Hanover Medical Research
  • The Center for Clinical Research, LLC & Carolinas Pain Institute, P.A.
  • David Schneider, MD
  • Community Research
  • North Star Medical Research, LLC
  • Bone, Joint & Spine Surgeons, Inc.
  • Neurology & Neruoscience Center of Ohio
  • Alleghany Pain Management, PC
  • Paragon Clinical Research Inc.
  • Omega Clinical Research
  • Future Search Trials
  • Austin Diagnostic Clinic
  • KRK Medical Research
  • Clinical Trial Network
  • Medex Healthcare Research
  • Sun Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EN3324 (axomadol)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

To evaluate the efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.

Secondary Outcome Measures

To evaluate the safety, tolerability and efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.
To evaluate patient reported outcomes of EN3324 (axomadol) in subjects with moderate to severe CLBP.

Full Information

First Posted
December 18, 2009
Last Updated
March 13, 2015
Sponsor
Grünenthal GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT01043263
Brief Title
Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain
Acronym
CLBP
Official Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grünenthal GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EN3324 (axomadol)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
EN3324 (axomadol)
Intervention Description
twice daily dosing
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
twice daily dosing
Primary Outcome Measure Information:
Title
To evaluate the efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.
Time Frame
Change from baseline [Day 0] to final visit [Day 112]
Secondary Outcome Measure Information:
Title
To evaluate the safety, tolerability and efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.
Time Frame
Change from baseline [Day 0] to final visit [Day 112]
Title
To evaluate patient reported outcomes of EN3324 (axomadol) in subjects with moderate to severe CLBP.
Time Frame
Change from baseline [Day 0] to final visit [Day 112]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Matthew Doust, MD
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Paradigm Clinical
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85705
Country
United States
Facility Name
Visions Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Genova Clinical Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Quality of Life Medical & Research Center
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Orange County Clinical Trials, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Associated Pharmaceutical Research Center, Inc.
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Paradigm Clinical Research
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Facility Name
Synergy Escondido
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Triwest Research Associates
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
LBCCR
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Pacific Institute for Med Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Samaritan Center for Medical Research
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Synergy Research Center
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Mountain View Clinical Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Avail Clinical Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Neuropsychiatric Research Center of SW Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
CNS Healthcare
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Florida Institute of Medical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
Country
United States
Facility Name
Behavioral Clinical Research, Inc.
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Segal Institute for Clinical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
CNS Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Altas Orthopedics & Sports Medicine
City
Orlando
State/Province
Florida
ZIP/Postal Code
32822
Country
United States
Facility Name
Gold Coast Research LLC.
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Medex Healthcare Research, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60603
Country
United States
Facility Name
Center for Pain Management Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Integrated Clinical Trial Services Inc.
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
International Clinical Research Institute Inc.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Robert Wagner, MD
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Four Rivers Clinical Research
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Beacon Clinical Research LLC
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Quest Research Institute
City
Bingham Farms
State/Province
Michigan
ZIP/Postal Code
48025
Country
United States
Facility Name
Prime Care Research Associates
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
Medex Health Research, Inc.
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Sundance Clinical Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Office of Danka Micheals, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Stephen Miller, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
New Hanover Medical Research
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
The Center for Clinical Research, LLC & Carolinas Pain Institute, P.A.
City
Winstom-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
David Schneider, MD
City
Cincinnari
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
North Star Medical Research, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Bone, Joint & Spine Surgeons, Inc.
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Neurology & Neruoscience Center of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Alleghany Pain Management, PC
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Paragon Clinical Research Inc.
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Omega Clinical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Facility Name
Future Search Trials
City
Ausitn
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Austin Diagnostic Clinic
City
Ausitn
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
KRK Medical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Medex Healthcare Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs