Evaluation of the effectiveness and safety of ALKACITRAT® on the treatment of functional dyspepsia

Phase 1

• Conditions: Functional Dyspepsia; MedDRA version: 20.1Level: LLTClassification code: 10064536Term: Functional dyspepsia Class: 10017947; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2024-512688-30-00
• Lead Sponsor: ni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-22
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Patients with symptoms of functional indigestion will be included if all of the following inclusion criteria apply: 1.Women or men aged 18-75 years old. 2.Patients that meet the Rome IV criteria of functional dyspepsia. 3.Patients with a GOS score=4. 4.Patients who are legally competent and able to understand the information about the study, have been informed of the nature, scope and utility of the study, voluntarily agree to participate and have signed the informed consent form (ICF).

Exclusion Criteria

Exclusion criteria Patients will be excluded if any of the following exclusion criteria apply: 1.Pregnant and lactating women 2.Patients with symptoms of irritable bowel syndrome and gastroesophageal reflux disease. 3.Patients with suspected symptoms of severe disease (weight loss, black stools, difficulty in swallowing). 4.Abdominal surgery. 5.Unregulated diabetes. 6.Stool disorders (chronic diarrhea or constipation). 7.Active psychiatric conditions 8.Intake of immunosuppressants, antibiotics, non-steroidal, anti-inflammatory drugs or probiotics in the last 4 weeks 9.Taking oral antacid medications that act as proton pump inhibitors, prokinetic agents, histamine receptor antagonists, and laxatives during the study 10.Patients that daily use aspirin 11.Alcohol use of more than ten units (units) per week 12.Active H. pylori infection 13.Participation in another study of an investigational medicinal product or investigational medical device

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified