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

March 13, 2015 updated by: Grünenthal GmbH

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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]
Change from baseline [Day 0] to final visit [Day 112]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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]
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.
Time Frame: Change from baseline [Day 0] to final visit [Day 112]
Change from baseline [Day 0] to final visit [Day 112]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Grünenthal GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EN3324-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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