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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

December 18, 2009
January 6, 2010
April 2, 2015
December 2009
June 2011   (Final data collection date for primary outcome measure)
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] ]
To evaluate the efficacy of EN3324 in subjects with moderate to severe CLBP. [ Time Frame: Change from baseline [Day 0] to final visit [Day 112] ]
Complete list of historical versions of study NCT01043263 on ClinicalTrials.gov Archive Site
  • 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] ]
  • 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] ]
  • To evaluate the safety, tolerability and efficacy of EN3324 (in subjects with moderate to severe CLBP. [ Time Frame: Change from baseline [Day 0] to final visit [Day 112] ]
  • To evaluate patient reported outcomes of EN3324 in subjects with moderate to severe CLBP. [ Time Frame: Change from baseline [Day 0] to final visit [Day 112] ]
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Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain
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
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
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Low Back Pain
  • Drug: EN3324 (axomadol)
    twice daily dosing
  • Drug: Placebo
    twice daily dosing
  • Experimental: EN3324 (axomadol)
    Intervention: Drug: EN3324 (axomadol)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
236
240
June 2011
June 2011   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01043263
EN3324-201
No
Not Provided
Not Provided
Grünenthal GmbH
Grünenthal GmbH
Not Provided
Not Provided
Grünenthal GmbH
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP