Clinical Trial: Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-blind, Double-dummy, Active Drug Parallel Controlled, Multi-center Clinical Trial on the Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional

Brief Summary: The purpose of this study is to compare Cinitapride tablets with domperidone tablets (motilium), and to evaluate the efficacy and safety of Cinitapride tablets in the treatment of mild to moderate functional dyspepsia.

Detailed Summary:
Sponsor: Eisai China Inc.

Current Primary Outcome: Response rate of overall symptom improvement after 4-weeks treatment [ Time Frame: 4 weeks ]

Original Primary Outcome: Response rate of overall symptom improvement after 4-weeks treatment. [ Time Frame: 4 weeks ]

Current Secondary Outcome:

  • Percentage change of overall symptom score of functional dyspepsia from baseline after 2 and 4 weeks treatment [ Time Frame: 2 and 4 weeks ]
  • Response rate after 2 weeks treatment [ Time Frame: 2 weeks ]
  • Percentage change of individual symptom score (early satiety, discomfort with fullness after meal, flatulence, epigastric pain, epigastric burning, nausea, vomiting and belching) after 2 and 4 weeks treatment compared with the baseline [ Time Frame: 2 and 4 weeks ]
  • Changes of gastric emptying in some patients after 4-week treatment [ Time Frame: 4 weeks ]
  • Patient's global subjective assessment (Likert scale score) after 2 and 4 weeks treatment [ Time Frame: 2 and 4 weeks ]


Original Secondary Outcome:

  • Percentage change of overall symptom score of functional dyspepsia from baseline after 2 and 4 weeks treatment [ Time Frame: 2 and 4 weeks ]
  • Response rate after 2 weeks treatment. [ Time Frame: 2 weeks ]
  • Percentage change of individual symptom score (early satiety, discomfort with fullness after meal, flatulence, epigastric pain, epigastric burning, nausea, vomiting and belching) after 2 and 4 weeks treatment compared with the baseline. [ Time Frame: 2 and 4 weeks ]
  • Changes of gastric emptying in some patients after 4-week treatment. [ Time Frame: 4 weeks ]
  • Patient's global subjective assessment (Likert scale score) after 2 and 4 weeks treatment. [ Time Frame: 2 and 4 weeks ]


Information By: Eisai Inc.

Dates:
Date Received: May 16, 2011
Date Started: October 2010
Date Completion:
Last Updated: November 29, 2011
Last Verified: November 2011