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Clinical trial

A Randomized Withdrawal, Active- and Placebo-controlled, Double-blind, Multi-center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 (Tapentadol) Prolonged Release (PR*) in Subjects With Moderate to Severe Chronic Malignant Tumor-related Pain. *Prolonged Release and is the Recommended Nomenclature for Use in the European Union (EU). ER Means Extended Release and is the Recommended Nomenclature for Use in the United States of America (USA). "PR" is Synonymous With "ER" and is Interchangeable.

NCT00505414 is registered in ClinicalTrials.gov with Grünenthal GmbH as lead sponsor.

NCT NCT00505414
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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized Withdrawal, Active- and Placebo-controlled, Double-blind, Multi-center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 (Tapentadol) Prolonged Release (PR*) in Subjects With Moderate to Severe Chronic Malignant Tumor-related Pain. *Prolonged Release and is the Recommended Nomenclature for Use in the European Union (EU). ER Means Extended Release and is the Recommended Nomenclature for Use in the United States of America (USA). "PR" is Synonymous With "ER" and is Interchangeable.
Lead sponsor
Grünenthal GmbH
Phase
Phase 3
Overall status
Terminated
Start date
June 30, 2007
Completion date
May 31, 2009
Enrollment
136 (actual)
Sites
37

Conditions

As the registry lists them; a condition with its own page is linked.

cancer, neoplasm, pain