A Phase 1/2 interventional study of Esomeprazole and Placebo in Dyspepsia, sponsored by University of Monastir. Completed at 1 site in Tunisia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-25.
Sponsored by University of Monastir · Phase 1/2, Interventional, and Prevention
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.
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.
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 500 is above the median of 87 across 297 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →University of Monastir is the lead sponsor of 112 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
-
Exclusion Criteria:
Patients are given proton pump inhibitors tablets once a day
Drug: Esomeprazole
Patients are given a placebo instead of proton pump inhibitors active drug
Drug: Placebo
Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan
Also known as: Nexium
Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan
Overall symptom relief during the 4 weeks of treatment
Relief of dyspepsia symptoms during the treatment period according to the decrease of SF-LDQ score
Time frame: 30 days after inclusion
number of days without dyspepsia
the number of days with SF-LDQ score \<1
Time frame: 30 days after inclusion
quality of life assessment
quality of life assessment ccording to the SF-36 score
Time frame: 30 days after inclusion
Patients satisfaction of the treatment
Patients satisfaction according to Likert score
Time frame: 30 days after inclusion
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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University of Monastir