The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.
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|ClinicalTrials.gov Identifier: NCT00315887|
Recruitment Status : Completed
First Posted : April 19, 2006
Last Update Posted : May 3, 2006
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low Back Pain||Drug: Buprenorphine transdermal delivery system||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Double-Blind Comparative Study of Buprenorphine Transdermal System (BTDS) and Hydrocodone/Acetaminophen Tablets in Patients With Chronic Back Pain|
|Study Start Date :||April 1999|
|Study Completion Date :||October 1999|
- Patient Satisfaction With Medication for Pain and Average Pain Intensity scores on days 0, 7, 14, 21, 28, 35, 42, 49, 56 and, if applicable, at early termination.
- Average Pain Intensity and Patient Satisfaction With Medication for Pain scores (Patient Global Efficacy Rating)
- incidence of and time to early discontinuation due to lack of efficacy
- investigator's assessment of therapeutic response
- dose level at the end of titration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315887