Comparing Acotiamide and Itopride for the Management of Indigestion
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAga Khan University
About this trial
This study is a randomized, double-blinded trial that will compare the effectiveness of two medications, acotiamide and itopride, in treating Functional Dyspepsia. Functional Dyspepsia causes uncomfortable symptoms arising from the gastro-duodenal region, such as fullness after meals, early satiation, stomach pain, and burning.
The primary aim of this trial is to determine whether acotiamide is superior to itopride-specifically by a margin of 15%-at improving these meal-related digestive symptoms.
Participants will be involved in the study for a total of 5 weeks. The study begins with a 7-day baseline period where participants will track their symptoms daily.
Following the baseline period, participants will be randomly assigned to receive either 100mg of acotiamide three times a day or 50mg of itopride three times a day.
The treatment phase will last for 4 weeks, during which participants will take the medication before meals on an empty stomach.
Participants will continue to track their symptoms daily and will complete questionnaires about their overall treatment effect and quality of life at follow-up visits.
Eligibility criteria
Qualifiers
Patients experiencing bothersome post-prandial fullness or bothersome early satiation at least three days a week.
Symptom onset must have occurred six months prior to diagnosis, and symptoms must have been present for at least the past three months.
No evidence of organic, systemic, or metabolic disease based on clinical investigations and endoscopy.
Patients with co-existing symptoms of Epigastric Pain Syndrome (EPS) are included only if the symptoms causing the most distress are meal-related.
Disqualifiers
Patients with an identifiable organic disease that can explain their symptoms, such as peptic ulcer, GERD, or chronic pancreatitis.
Patients with a history of gastrointestinal surgery.
History of malignancy in the past five years.
Patients having major psychiatric or depressive disorders.
Trial design
Treatments tested in this trial
- Acotiamide
- itopride
Treatment groups
368 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Aga Khan University
Lead sponsor
The Searle Company Limited Pakistan
Collaborator
Source ClinicalTrials.gov