Betaine citrate for Functional dyspepsia

Inclusion criteria

• {"criterion_text":"- Patients with symptoms of functional indigestion will be included if all of the following inclusion criteria apply:\n- Women or men aged 18-75 years old.\n- Patients that meet the Rome IV criteria of functional dyspepsia.\n- Patients with a GOS score≥4.\n- 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

• {"criterion_text":"- Pregnant and lactating women\n- Patients with symptoms of irritable bowel syndrome and gastroesophageal reflux disease.\n- Patients with suspected symptoms of severe disease (weight loss, black stools, difficulty in swallowing).\n- Abdominal surgery.\n- Unregulated diabetes.\n- Stool disorders (chronic diarrhea or constipation).\n- Active psychiatric conditions\n- Intake of immunosuppressants, antibiotics, non-steroidal, anti-inflammatory drugs or probiotics in the last 4 weeks\n- Taking oral antacid medications that act as proton pump inhibitors, prokinetic agents, histamine receptor antagonists, and laxatives during the study\n- Patients that daily use aspirin\n- Alcohol use of more than ten units (units) per week\n- Active H. pylori infection\n- Participation in another study of an investigational medicinal product or investigational medical device"}

Primary endpoints

• {"endpoint_text":"- Comparison of the percentage of patients with improvement (ΔGOS ≥2) at the end of treatment (visit V1) compared to the baseline visit (V0) between the two treatment groups.","definition_or_measurement_approach":"Improvement defined as change in GOS score (ΔGOS) of ≥2 from baseline (V0) to end of treatment (V1); endpoint is the percentage of patients meeting this criterion compared between the two treatment groups."}

Secondary endpoints

• {"endpoint_text":"- Comparison of the percentage of patients who responded to treatment (GOS score ≤2 at visit V1) between treatment groups\n- Comparison of the change in patients' quality of life based on the NDI-SF index at visit V1 versus baseline visit (V0) between the two treatment groups.\n- Comparison of the change in severity of each symptom (VAS scale) at the end of treatment (visit V1) compared to the baseline visit (V0) between the two treatment groups.\n- Comparison of the percentage of patients in whom there was a decrease in GOS scale score of at least one point at visit V1 compared to the baseline visit (V0) between the two treatment groups.\n- Frequency and type of adverse events during the study.","definition_or_measurement_approach":"Responder: GOS score ≤2 at V1. Quality of life measured by NDI-SF index change from V0 to V1. Symptom severity measured by VAS scale change from V0 to V1. Percentage with ≥1-point decrease in GOS from V0 to V1. Safety assessed by recording frequency and type of adverse events during the study."}

Greece

Earliest CTIS Part Ii Submission Date

01-05-2024

Latest Decision Or Authorization Date

15-07-2024

Processing Time Days

75

Number Of Sites

1

Number Of Participants

92

Primary sponsor

Full Name

Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Greece