A pilot study of Itopride Hydrochloride prolonged release capsule (Ganaton OD; 150 mg) in diabeticgastroparesis patients with dyspepsia and alteration in ANMS GCSI – DD, electrogastrography (EGG) and nuclearScintigraphy parameters - EGG Study

Abbott India Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年9月18日

试验速览

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•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

•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.

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