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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01043263
First received: December 18, 2009
Last updated: September 2, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to determine the efficacy and safety of EN3324 in subjects with moderate to severe chronic low back pain


Condition Intervention Phase
Chronic Low Back Pain
Drug: EN3324
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 in Subjects With Moderate to Severe Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • 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] ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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] ] [ Designated as safety issue: Yes ]
  • 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] ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: December 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EN3324 Drug: EN3324
twice daily dosing
Placebo Comparator: Placebo Drug: Placebo
twice daily dosing

Detailed Description:

A phase IIB, randomized, double-blind, two-arm, multi-center, placebo-controlled, study to assess the efficacy and safety of EN3324 in subjects with moderate to severe chronic low back pain

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043263

  Show 59 Study Locations
Sponsors and Collaborators
Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01043263     History of Changes
Other Study ID Numbers: EN3324-201
Study First Received: December 18, 2009
Last Updated: September 2, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014