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A Dose Titration Study of Fentanyl Buccal Soluble Film for Breakthrough Cancer Pain in Taiwan

Chang Gung Memorial Hospital · 2014
ClinicalTrials.gov · Datasets · License: Public Domain · 2014
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Primary Objective: To determine the feasible dose range of Painkyl® required for Taiwanese population. Secondary Objectives: To evaluate the efficacy of Painkyl® by calculating squared mean of pain intensity difference at 30 minutes after taking Painkyl® (SPID30, an 11-point scale). To evaluate subjects' satisfaction by conducting global evaluation of medication performance (a 5-point categorical scale). To identify percentage of episodes requiring rescue medication during maintenance treatment period. To evaluate the safety data of Painkyl® for breakthrough pain.
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