A pilot study to check the efficacy of Itopride Hydrochloride prolonged release capsule (Ganaton OD; 150 mg) in diabetic gastroparesis patients with dyspepsia

Not Applicable

• Conditions: Health Condition 1: K319- Disease of stomach and duodenum, unspecified

• Registration Number: CTRI/2023/09/057158
• Lead Sponsor: Abbott India Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified