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

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ClinicalTrials.gov Identifier: NCT01043263
Recruitment Status : Completed
First Posted : January 6, 2010
Last Update Posted : April 2, 2015
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Drug: EN3324 (axomadol) Drug: Placebo Phase 2

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  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
Experimental: EN3324 (axomadol) Drug: EN3324 (axomadol)
twice daily dosing
Placebo Comparator: Placebo Drug: Placebo
twice daily dosing



Primary Outcome Measures :
  1. 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 Measures :
  1. 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] ]
  2. 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] ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043263


  Show 59 Study Locations
Sponsors and Collaborators
Grünenthal GmbH

Responsible Party: Grünenthal GmbH
ClinicalTrials.gov Identifier: NCT01043263     History of Changes
Other Study ID Numbers: EN3324-201
First Posted: January 6, 2010    Key Record Dates
Last Update Posted: April 2, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms