Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting

University of Monastir

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dyspepsia

Treatments: Drug: Esomeprazole; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05287633

PPI

Details and patient eligibility

About

evaluate the interest of proton pump inhibitors in subjects with or with GI symptoms who intend to observe fasting in Ramadan. The investigators will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during Ramadan compared to placebo.

Full description

evaluate the interest of proton pump inhibitors in subjects with or with GI symptoms who intend to observe fasting in Ramadan. Investigators will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during at least Ramadan compared to placebo.

The study will be conducted at least from April 2019 to at least June 2030.The study is prospective, two parallel groups, randomized controlled and double blind.

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Exclusion criteria

• Diagnosed GastroDuodenal Ulcer

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups, including a placebo group

A : Proton Pump Inhibitors

Active Comparator group

Description:

Patients are given proton pump inhibitors tablets once a day

Treatment:

Drug: Esomeprazole

B: Placebo

Placebo Comparator group

Description:

Patients are given a placebo instead of proton pump inhibitors active drug

Treatment:

Drug: Placebo