Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting

Dyspepsia Clinical Trial

Official title:

Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05287633
• Other study ID #: PPI
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 20, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2023
• Source: University of Monastir
• Contact: Semir Nouira, Professor
• Phone: 73106046
• Email: semir.nouira[@]rns.tn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 30, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-

Exclusion Criteria:

• Diagnosed GastroDuodenal Ulcer

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Drug:
• Esomeprazole
Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan
• Placebo
Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan

Locations

Country	Name	City	State
Tunisia	Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days after inclusion
Secondary	number of days without dyspepsia	the number of days with SF-LDQ score <1	30 days after inclusion
Secondary	quality of life assessment	quality of life assessment ccording to the SF-36 score	30 days after inclusion
Secondary	Patients satisfaction of the treatment	Patients satisfaction according to Likert score	30 days after inclusion