Last reviewed · How we verify
NCT01089543
A Multi-Center, Randomized, Double-Blind Study of E3810 for Japanese Subjects With Functional Dyspepsia
Phase 2 trial testing Rabeprazole in Functional Dyspepsia in 338 participants. Completed in 1 August 2011.
1 August 2011
Quick facts
| Lead sponsor | Eisai Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 338 |
| Start date | 1 April 2010 |
| Primary completion | 1 August 2011 |
| Estimated completion | 1 August 2011 |
| Sites | 46 locations across Japan |
Drugs / interventions tested
- Rabeprazole — full drug profile →
- Rabeprazole — full drug profile →
- Rabeprazole — full drug profile →
- Placebo
Conditions studied
- Functional Dyspepsia — all drugs for Functional Dyspepsia →
Sponsor
Eisai Co., Ltd. — full company profile →
Who can join
20 and older, any sex, with Functional 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.
-
Rate of Complete Dyspepsia Symptom Relief
Time frame: Up to 8 Weeks (including 7 days prior)
The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants.
Sponsor's own description
The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Proton pump inhibitors for functional dyspepsia.
Pinto-Sanchez MI, Yuan Y, Hassan A, Bercik P, et al · · 2017 · cited 54× · PMID 29161458 · DOI 10.1002/14651858.cd011194.pub3 -
Randomised clinical trial: rabeprazole improves symptoms in patients with functional dyspepsia in Japan.
Iwakiri R, Tominaga K, Furuta K, Inamori M, et al · · 2013 · cited 47× · PMID 23957383 · DOI 10.1111/apt.12444 -
Proton pump inhibitors for functional dyspepsia.
Pinto-Sanchez MI, Yuan Y, Bercik P, Moayyedi P. · · 2017 · cited 41× · PMID 28271513 · DOI 10.1002/14651858.cd011194.pub2
Verify or expand the search:
- PubMed search for NCT01089543
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Rabeprazole
Trials testing the same drug.
- NCT07471867 — Effect of ZaStaprazan on Platelet Reactivity of Clopidogrel After PercuTaneous CoronAry InteRvention · Phase 4 · not yet recruiting
- NCT07329972 — A Study to Evaluate the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-1041 in Healthy Partici · Phase 1 · recruiting
- NCT07284173 — A Study to Learn if a Medicine That Reduces Stomach Acid Affects the Blood Level of Study Medicine PF-08049820 in Health · Phase 1 · active not recruiting
- NCT07141381 — A Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of VRN110755 · Phase 1 · recruiting
- NCT06899061 — Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saru · Phase 1 · active not recruiting
Other recruiting trials for Functional Dyspepsia
Currently open trials in the same condition.
- NCT07442734 — Auricular Stimulation for Functional Dyspepsia With Insomnia: Efficacy and Mechanisms · NA · recruiting
- NCT07250308 — Correlation Study of Atrophic Gastritis and Dyspepsia Symptoms · recruiting
- NCT07187492 — Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia · Phase 4 · recruiting
- NCT07182890 — Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia · Phase 4 · recruiting
- NCT07210294 — Press Needle on Body Acupuncture Points and Auricular Acupuncture Points on Functional Dyspepsia · NA · recruiting
Other Eisai Co., Ltd. trials
Trials by the same sponsor.
- NCT07515014 — A Study of E6742 in Participants With Systemic Lupus Erythematosus · Phase 2 · not yet recruiting
- NCT06793709 — A Post-marketing Observational Study of Tasfygo in Participants With Unresectable Biliary Tract Cancer With Fibroblast G · recruiting
- NCT06657378 — A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized T · recruiting
- NCT06322667 — A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab · recruiting
- NCT05633108 — A Study Based on the French National Health Insurance Database in Participants With Psychotic Disorders · completed
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 NCT01089543 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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 Co., Ltd.
- Last refreshed: 27 November 2013
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/NCT01089543.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing