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The primary objective is to compare the efficacy and safety of extended release tramadol HCl/acetaminophen with placebo for the treatment of chronic low-back pain by measuring the pain intensity difference between baseline and week 4.
This is a randomized (study drug assigned by chance), double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled, parallel group and up-titration study. At screening, patients taking non-steroidal anti-inflammatory drugs (NSAIDS) or COX-2 selective inhibitors (NSAID that specifically inhibits an enzyme known as cyclooxygenase-2) for the treatment of severe chronic lower back pain will be instructed to continue this treatment through the 7 day screening period, at which point their suitability for on-going participation in the study is determined by comparing their baseline average pain intensity to that of the last 48 hours. Patients will be randomized to receive either study drug Tramadol HCl/acetaminophen Extended Release or its equivalent placebo. Patients will take 1 tablet of Tramadol HCl/acetaminophen Extended Release at bedtime for 3 days, then 1 tablet twice a day for 3 days. After the first 3 days, the patient will receive a telephone inquiry monitoring for the occurrence of adverse events and will be given additional administration instructions for the next 4 days. From day 7, patients will take 1 or 2 tablets twice a day depending on the degree of pain relief required. Patients will visit the center on the 8, 15, and 29 day (Visit 3, 4, and 5) after starting study drug. On visits 3 - 5 or if the patient discontinues from the study for any reason, the investigator will evaluate the average pain intensity level and the pain relief experienced over the past 48 hours. When the double-blind part the study is complete, the KOREAN SF-36 and K-ODI (questionnaires patients are asked to complete that are used as tools to evaluate health outcomes) will be evaluated. On the last visit, the overall effectiveness of the study drug in controlling chronic lower back pain and all adverse events after the administration of the study drug will be reviewed. 1 tablet of tramadol HCl/acetaminophen at bedtime for 3 days, then 1 tablet twice a day for 3 days. Starting at day 7, patients will take 1 or 2 tablets twice a day depending on their need for pain relief. After completing the screening period, each patient will be randomized to receive either the study drug (or its equivalent placebo) until study completion, day 29
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Low Back Pain
Tramadol HCl/acetaminophen Extended Release, Tramadol HCl/acetaminophen Extended Release, Placebo, Placebo
Janssen Korea, Ltd., Korea
Published on BioPortfolio: 2014-07-24T14:05:56-0400
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