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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000326
Enrollment
150
Registered
2006-02-07
Start date
2005-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional dyspepsia

Interventions

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

Sponsors

Japanese Sciety for treatment of Functional dyspepsia
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: FD patients who meet Rome II criteria 1. patients who had at least one symptom described below in one week preceding the study pain, discomfort of epigastrium, bloating, abdominal fullness, early satiety, nausea or vomiting, appetite loss, belching. 2. patients who had no organic lesions that were confirmed by upper GI endoscopy within 6 months. 3. patients who are older than 20 years at entry. 4. out patients. 5. patients who understand the study contents and give informed consents by themselves

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
symptom resolution (improvement)

Secondary

MeasureTime frame
imprvement of quality of eibe

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026