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Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting

Sponsor
University of Monastir (Other)
Overall Status
Recruiting
CT.gov ID
NCT05287633
Collaborator
(none)
500
Enrollment
1
Location
2
Arms
151.2
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
the objective is to evaluate the interest of proton pump inhibitors in subjects with or without GI symptoms who intend to observe fasting in Ramadan. We will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during at least Ramadan as compared to placebo.the objective is to evaluate the interest of proton pump inhibitors in subjects with or without GI symptoms who intend to observe fasting in Ramadan. We will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during at least Ramadan as compared to placebo.
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting
Actual Study Start Date :
May 24, 2018
Anticipated Primary Completion Date :
Jan 1, 2030
Anticipated Study Completion Date :
Dec 30, 2030

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: A : Proton Pump Inhibitors

Patients are given proton pump inhibitors tablets once a day

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

    		•
    Placebo Comparator: B: Placebo

    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

    Outcome Measures

    Primary Outcome Measures

    1. Overall symptom relief during the 4 weeks of treatment [30 days after inclusion]

      Relief of dyspepsia symptoms during the treatment period according to the decrease of SF-LDQ score

    Secondary Outcome Measures

    1. number of days without dyspepsia [30 days after inclusion]

      the number of days with SF-LDQ score <1

    2. quality of life assessment [30 days after inclusion]

      quality of life assessment ccording to the SF-36 score

    3. Patients satisfaction of the treatment [30 days after inclusion]

      Patients satisfaction according to Likert score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    Exclusion Criteria:
    • Diagnosed GastroDuodenal Ulcer

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia Monastir Tunisia 5000

    Sponsors and Collaborators

    • University of Monastir

    Investigators

    • Principal Investigator: Semir Nouira, Professor, University of Monastir

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pr. Semir Nouira, professor, University of Monastir
    ClinicalTrials.gov Identifier:
    NCT05287633
    Other Study ID Numbers:
    • PPI
    First Posted:
    Mar 18, 2022
    Last Update Posted:
    Mar 18, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pr. Semir Nouira, professor, University of Monastir
    fasting
    Proton Pump Inhibitors
    dyspepsia
    Additional relevant MeSH terms:
    Dyspepsia
    Esomeprazole

    Study Results

    No Results Posted as of Mar 18, 2022