Back to results

Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting

Primary Purpose

Dyspepsia

Status

Recruiting

Phase

Phase 1

Locations

Tunisia

Study Type

Interventional

Intervention

Esomeprazole

Placebo

About this trial

This is an interventional prevention trial for Dyspepsia focused on measuring fasting, Proton Pump Inhibitors, dyspepsia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Exclusion Criteria:

Diagnosed GastroDuodenal Ulcer

Sites / Locations

Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir TunisiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A : Proton Pump Inhibitors

B: Placebo

Arm Description

Patients are given proton pump inhibitors tablets once a day

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

number of days without dyspepsia

the number of days with SF-LDQ score <1

quality of life assessment

quality of life assessment ccording to the SF-36 score

Patients satisfaction of the treatment

Patients satisfaction according to Likert score

Full Information

NCT ID

NCT05287633

First Posted

September 10, 2020

Last Updated

May 13, 2023

Sponsor

University of Monastir

1. Study Identification

Unique Protocol Identification Number

NCT05287633

Brief Title

Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting

Official Title

Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 20, 2023 (Actual)

Primary Completion Date

May 1, 2024 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Monastir

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyspepsia

Keywords

fasting, Proton Pump Inhibitors, dyspepsia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A : Proton Pump Inhibitors

Arm Type

Active Comparator

Arm Description

Patients are given proton pump inhibitors tablets once a day

Arm Title

B: Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Other Intervention Name(s)

Nexium

Intervention Description

Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Patients are given a box of capsules of which they take 1capsule/day during the month of ramadan

Primary Outcome Measure Information:

Title

Overall symptom relief during the 4 weeks of treatment

Description

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

Time Frame

30 days after inclusion

Secondary Outcome Measure Information:

Title

number of days without dyspepsia

Description

the number of days with SF-LDQ score <1

Time Frame

30 days after inclusion

Title

quality of life assessment

Description

quality of life assessment ccording to the SF-36 score

Time Frame

30 days after inclusion

Title

Patients satisfaction of the treatment

Description

Patients satisfaction according to Likert score

Time Frame

30 days after inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Exclusion Criteria: Diagnosed GastroDuodenal Ulcer

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Semir Nouira, Professor

Phone

73106046

Ext

216

semir.nouira@rns.tn

First Name & Middle Initial & Last Name or Official Title & Degree

Khaoula Bel Haj Ali, MD

Phone

7310600

Ext

216

belhajalikhaoula@yahoo.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Semir Nouira, Professor

Organizational Affiliation

University of Monastir

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia

City

Monastir

ZIP/Postal Code

5000

Country

Tunisia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Semir Nouira, Professor

semir.nouira@rns.tn

12. IPD Sharing Statement

Learn more about this trial

Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting

We'll reach out to this number within 24 hrs