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NCT01355276
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 Dyspepsia
Phase 3 trial testing Cinitapride in Dyspepsia in 400 participants. Completed in 1 October 2011.
1 June 2011
Quick facts
| Lead sponsor | Eisai China Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 400 |
| Start date | 1 October 2010 |
| Primary completion | 1 June 2011 |
| Estimated completion | 1 October 2011 |
| Sites | 13 locations across China |
Drugs / interventions tested
- Cinitapride (CINITAPRIDE) — full drug profile →
- domperidone (domperidone) — full drug profile →
Conditions studied
- Dyspepsia — all drugs for Dyspepsia →
Sponsor
Eisai China Inc. — full company profile →
Who can join
Adults 18 to 65, any sex, with Dyspepsia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Response rate of overall symptom improvement after 4-weeks treatment
Time frame: 4 weeks
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01355276
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Dyspepsia
Currently open trials in the same condition.
- NCT06941545 — High Resolution Gastric Mapping and Gastroduodenal Manometry · NA · recruiting
- NCT07261228 — The Difference in Carbon Footprint Between Diagnostic Upper GI Endoscopy in Dyspeptic Patients Versus Therapeutic Upper · recruiting
- NCT06755671 — A Prospective Multicentre Real-world Assessment of the Efficacy of Danning Tablets in Alleviating Digestive Symptoms · recruiting
- NCT06422052 — Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspep · recruiting
- NCT05810168 — Traditional Dietary Advice Versus Low FODMAP Diet in Postprandial Functional Dyspepsia · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01355276 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eisai China Inc.
- Last refreshed: 29 November 2011
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01355276.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing