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Randomized Contorolled Trial of efficacy of mosapride plus omeprazole versus omeprazole alone in therapy of gastroesophageal reflux disease

Randomized Contorolled Trial of efficacy of mosapride plus omeprazole versus omeprazole alone in therapy of gastroesophageal reflux disease - Tokyo university Omeprazole versus Gasmotin (R) (mosapride) plus Omeprazole study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000958
Enrollment
60
Registered
2007-12-27
Start date
2007-10-01
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

gastroesophageal reflux disease

Interventions

omeprazole 10mg qd after breakfast for 4 weeks omeprazole 10mg qd after breakfast plus mosapride 5mg tid for 4 weeks

Sponsors

Department of Gastroenterology, The University of Tokyo Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient who fills everything the following 1)Patient with GERD(erosive and nonerosive) 2)Patient of 20 years or more 3)Patient who gives written informed consent 4)Outpatient and in-patient

Exclusion criteria

Exclusion criteria: The patient who collides with either the following assumes that it doesn't put it in to the examination 1)Patient with gastric or duodenal ulcer 2)Patient with malignant neoplasm, diabetes or thyroid disease 3)Patient who has severe liver disease.(AST(GOT) or ALT(GPT) is 100 U or more ) 4)Patient who has severe renal dysfunction(BUN 25mg/dL or more or serum creatinine 2.0 mg/dL or more) 5)Patient who has the pasts of digestive tract operations other than appendectomy 6)Patient who took medicine that influences movement and function of digestive tract such as proton pump inhibitor, H2 blocker, and NSAIDs within 4 weeks 7)Alcohol or drug abuse 8)Pregnant females and lactating women 9)Patient whom examination doctor judged improper as testee

Design outcomes

Primary

MeasureTime frame
The primary efficacy endpoint is improvement in the FSSG(Frequency Scale for the Symptoms of GERD).The FSSG was performed before the study.After 4 weeks of therapy with either regimen, FSSG was performed again.The levels of the improvement of the GERD symptom are compared in omeprazole and omeprazole plus mosapride .

Secondary

MeasureTime frame
1.GSRS score after 4 weeks 2.FSSG score stratified by nonerosive GERD and erosive GERD

Countries

Japan

Outcome results

None listed

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