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Efficacy and Safety of EN3324 in Subjects With Chronic Low Back Pain - NCT01043263-16602(Clinical Trial 492740)



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City:  Altoona
State:  
PA
Zip Code: 16602
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)
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: January 6, 2011
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