Different times of administration of Pantoprazole on the control of heartburn in patients with Gastroesophageal Reflux

Phase 2

Recruiting

• Conditions: Gastroesophageal Reflux; Hiatal Hernia; C06.405.117.119.500

• Registration Number: RBR-24fcn7p
• Lead Sponsor: niversidade Federal da Fronteira Sul

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-06
• Study Completion: 2023-03-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Age greater than or equal to 18 years; both genders; body mass index between 18.5 and 39.9 kg/m2; chief complaint of heartburn (current if not on treatment or controlled with proton pump inhibitor); diagnosis of sliding hiatal hernia (2 cm or more) confirmed by digestive endoscopy

Exclusion Criteria

Not having at least three meals a day regularly, including breakfast, lunch and dinner; cognition and communication difficulties; esophagogastric surgery of any nature; pregnant and lactating women; women in the fertile period without using a contraceptive method; alcohol or tobacco abuse (>10 cigarettes/day); decompensated systemic disease (arterial hypertension, diabetes mellitus, cirrhosis, chronic renal failure, lung disease and any infectious condition); not having heartburn after 5 days of discontinuing the proton pump inhibitor (PPI), if using it

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main outcome of the study is the control of heartburn, which will be evaluated through the frequency and severity of episodes during the intervention, measured by self-completed diary and questionnaires.

Secondary Outcome Measures

Name	Time	Method
As a secondary outcome, adherence to treatment will be evaluated, measured through the diary, which should contain every time the capsules were administered.