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Efficacy and Safety of EN3324 in Subjects With Chronic Low Back Pain - NCT01043263-48025(Clinical Trial 464172)



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City:  Bingham Farms
State:  
MI
Zip Code: 48025
Conditions: Chronic Low Back Pain
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
Study summary: 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
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)
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Data Source: ClinicalTrials.gov
Date Processed: January 6, 2011
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