Health Condition 1: K319- Disease of stomach and duodenum, unspecified
Conditions
Interventions
Intervention1: Ganaton OD
150mg: Itopride Hydrochloride Prolonged Release Capsule, Dose 150mg, administered after meal daily upto 12 weeks
Sponsors
Abbott India Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Male and female patients from 18 to 70 years of age Type I or Type II Diabetic patients with proven gastroparesis via nuclear scintigraphy Patients having symptoms of dyspepsia as per ROME IV criteria. ROME IV criteria for Functional Dyspepsia Diagnostic criteria, one or more of the following Bothersome postprandial fullness Bothersome early satiation Bothersome epigastric pain Bothersome epigastric burning Patient who has read the informed consent form, has understood the relevant aspects of the study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the study and the performance of any procedure Patient willing to use appropriate method of contraception as per investigator’s discretion, throughout the study No evidence of structural disease including at upper endoscopy that is likely to explain the symptoms Must fulfil criteria for Postprandial Distress Syndrome (PDS) and/or Epigastric Pain Syndrome (EPS) Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
Exclusion criteria
Exclusion criteria: Patients suffering from Diabetic Ketoacidosis. Patients with history of any bariatric procedures/gastric surgeries in the past. Females who are pregnant. Patients taking following medications within 72 hours to the start of the study: Opioids, TCA, Calcium channel blockers, anti-psychotics, anti-cholinergic, steroids &L-Dopa. Patients with electrolyte abnormalities like hypokalaemia & hypomagnesemia. Patients with known cases of thyroid disorder (hypo or hyperthyroidism). Patients who are unsuitable for any other reason to participate in the study in the opinion of the investigator Pregnant or lactating women; Patients with active gastroduodenal ulcer; Patients with history of gastric, duodenal/esophageal surgery, Patients with known hypersensitivity to the active substance Those who had participated in any other investigational drug trial in preceding 4 weeks of first assessment. Those on medications that effect gastrointestinal motility (e.g., prokinetics) 7 days prior to Baseline (Visit 2) Those on medications that might interfere with the action of the study drug prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean ANMS GCSI-DD score from baseline to end of the treatment that is Day 90/ Visit 5 Number & proportion of patients & categorization as per socio demographic & clinical profile Change in below EGG parameters at baseline versus Visit 5- Water load volume (water load satiety test) Number and Percentage of patients with changes in gastric emptying using nuclear scintigraphy at baseline versus end of the treatment that is Day 90/ visit 5. Timepoint: Baseline, Day 30, Day 60, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage frequency distribution of power in EGG in normogastria, bradygastria, tachygastrias, duodenal-respiration. Power ratio - Ratio of post-prandial to fasting in DP. Dominant power (DP) Number, severity & proportion of patients with adverse events (AEs) & serious adverse events (SAEs) Change in laboratory parameters at baseline versus Visit 5 Change in the physical examination from baseline to Visit 5 Change in vital signs (pulse rate, systolic & diastolic blood pressure [SBP & DBP]) from baseline to Visit 5 Global tolerability assessment by patient & investigator from Visit 3 to Visit 5 graded on a 3-point scale ranging from “good tolerability (side effects may be mild or not observed) ? to poor tolerability (side effects severe of discontinuation) ? Timepoint: Baseline, Day 30, Day 60, Day 90 | — |
Countries
India
Contacts
Public ContactDr Sundeep Lakhtakia
AIG Hospitals Hyderabad
Outcome results
None listed