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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Acotiamide
Drug100mg thrice daily, before meals on an empty stomach for 4 weeks.
itopride
Drug50mg thrice daily, before meals on an empty stomach for 4 weeks.
Treatment groups
368 Participants
are divided into 2 treatment groupsGroup A: Acotiamide ArmExperimental treatment 1 intervention
Group B: Itopride ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
: Overall Treatment Effect (OTE)
The primary outcome is evaluated using the Overall Treatment Effect (OTE) questionnaire to determine if acotiamide is superior to itopride in improving symptoms of functional dyspepsia. Participants will be asked to compare their current symptoms to their baseline using a 7-point Likert scale. The scale ranges from a minimum value of 1, which denotes "extremely improved compared to baseline," to a maximum value of 7, which denotes "extremely aggravated compared to baseline". Therefore, higher scores on this scale indicate a worse outcome. Patients selecting options 1 through 3 on the OTE scale will be considered responders to the treatment, while those selecting 4 through 7 will be considered non-responders.
Time frame
Week 1 and Week 4.Secondary outcomes
1
Quality of Life: Assessing changes in the patient's disease-specific quality of life.
Quality of Life is assessed to measure changes in the patient's disease-specific quality of life. This is measured using the unabbreviated Short form of the Nepean Dyspepsia Index (SF-NDI). The SF-NDI evaluates 5 subscales: tension, daily activity, eating/drinking, knowledge/control, and work/study. The scale for this index ranges from a minimum value of 1 to a maximum value of 5. On this scale, a lower score indicates a better quality of life, meaning that a higher score represents a worse outcome.
Time frame
Recorded on day 7 (end of baseline) and at the end of week 42
Symptom Severity: Participants will evaluate the severity of 9 specific upper gastrointestinal symptoms
Symptom severity is assessed by having participants evaluate 9 specific upper gastrointestinal symptoms: upper abdominal pain, post prandial fullness, upper abdominal discomfort, bloating, early satiation, excessive belching, nausea, vomiting, and heartburn. This is measured daily using the unabbreviated Symptom Severity Diary scale. The scale ranges from a minimum value of 0 to a maximum value of 3 for each individual symptom. On this scale, a higher score indicates greater symptom severity, meaning that a higher score represents a worse outcome.
Time frame
Throughout the 4-week periodLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aga Khan University
Lead sponsor
The Searle Company Limited Pakistan
Collaborator
Source ClinicalTrials.gov
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