Effect of tadospirone citrate on symptom resolution of patients with functional dyspepsia - A double-blind placebo-controlled trial

UMIN ID: C000000326

Registered date:07/02/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Functional dyspepsia
• Date of first enrollment: 2005/12/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Administration of anti-anxiety drug )Tandospirone Citrate) 30mg/day for one month
placebo

Outcome(s)

• Primary Outcome: symptom resolution (improvement)
• Secondary Outcome: imprvement of quality of eibe

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. patients who have obvious organic lesions such as malignancy, or peptic ulcers. 2. patients who have obvious causes for the symptoms such as overeating. 3. patients whose main symptom is heartburn. 4. patients who are or ore suspected IBS. 5. patients who have past history of surgery for upper GI diseases. 6. patients who have pathological anxiety, depression or obvious mental diseases. 7. patients with severe liver and renal diseases. 8. patients who took medicines described below within one week before the first day of the study; prokinetics, acid -inhibitory drugs (H2RA, PPI), PG drugs NSAIDs. 9. patients who took anti-anxiety drug or tranquilizer within 4 weeks before beginning of the study. 10. patients who are pregnancy, in breast-feeding or who wish pregnancy during the study period. 11. patients who are regarded in-eligible by the doctor who participates in this study.

Related Information

• Primary Sponsor: Japanese Sciety for treatment of Functional dyspepsia
• Source(s) of Monetary Support: The waksman foundation of japan inc.