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A multi-center, randomized, controlled study of the efficacy evaluation of gastroesophageal reflux disease (GERD)

A multi-center, randomized, controlled study of the efficacy evaluation of gastroesophageal reflux disease (GERD)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17011872
Enrollment
Unknown
Registered
2017-07-05
Start date
2017-07-10
Completion date
Unknown
Last updated
2017-07-10

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

Conditions

gastroesophageal reflux disease

Interventions

Group A:Omeprazole Enteric-coated Capsules
Group B:Esomeprazole Magnesium Enteric-coated Tablets
Group C:Omeprazole Enteric-coated Capsules and Itopride Hydrochloride Tablets

Sponsors

Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine,Z hejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged between 18-70 years old, male or female; (2) Gastroscopy is consistent with RE (A/B class) or non-esophageal mucosal injury (Los Angeles classification criteria) but with typical reflux, heartburn, post-sternal pain and other symptoms, and the duration of the disease is greater than 2 months, and the gerd-Q scale score is greater than 8; (3) Patients who have not taken antacids, prokinetic drugs or gastric mucosal protective agents within two weeks prior to enrollment ointestinal power were not taken in 2 weeks.

Exclusion criteria

Exclusion criteria: (1) Pregnant and lactating women; (2) severe heart, lung, liver, renal insufficiency, blood, endocrine disease, connective tissue disease and other malignant diseases; (3) there is a history of gastrointestinal surgery or other diseases such as cardiac atonia, intestinal obstruction and ulcerative colitis; (4) gastroscopy has the ability of other organic diseases such as peptic ulcer and gastric cancer; (5) have a history of drug allergy or mental illness; (6) do not cooperate with the treatment, do not follow the diagnosis on time or do not wish to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
GERD-Q;External symptom assessment of esophagus;gastroscope;esophageal motility test;48 hours PH + impedance;GAD-7;PHG-9;

Countries

China

Contacts

Public ContactNing Dai

Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine,Z hejiang University

ndaicn@yahoo.com+86 13867457664

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026