Gastricel-I

Phase 3

• Conditions: Alkaline gastritis due to duodenogastric reflux; Alkaline gastritis; Gastritis; Gastroenteritis; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Duodenogastric Reflux; Duodenal Diseases; Intestinal Diseases

• Registration Number: RPCEC00000273
• Lead Sponsor: Center for Pharmaceutical Research and Development, Havana, Cuba.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1- Patients with chronic alkaline gastritis due to duodenogastric reflux, diagnosed by clinical and endoscopic study and gastric biopsy.
2- Patients with bile reflux with intact or operated stomach, or patients with intact stomach but who have been surgically removed from the gallbladder.
3- Presence of one or more symptoms of the following: epigastralgia, pyrosis, vomiting (bilious or not).
4- Hematological and biochemical studies within the established ranges.
5-Written informed consent of the patient to participate in the investigation and to complete the established examinations.

Exclusion Criteria

1- Pregnancy, breastfeeding or puerperium.
2- Helicobacter pylori positive demonstrated by the method of urease and/or biopsy.
3- Patients with known chronic evolutive liver diseases that could alter the production in quantity or quality of bile acids.
4- Malabsorption syndrome produced by any etiology that could influence the excretion of bile acids.
5- Presence of duodenogastric reflux of haematic appearance in the endoscopy prior to inclusion in the study.
6- Malignant disease.
7- History of allergy or hypersensitivity to any component of the formulation.
8- Severe psychiatric disorder or mental incapacity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified