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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in mean ANMS GCSI-DD score from baseline to end of the treatment that is Day 90/ Visit 5
研究概览
简要总结
Thepresent study aims at evaluating the effect of Itopride Hydrochloride ProlongedRelease Capsule Hard (Ganaton OD; 150 mg) on altered gastrointestinal motilityaccording to symptomatic changes in patients suffering from Diabeticgastroparesis with dyspepsia. ANMS, GCSI-DD score is a patient-based symptominstrument used to assess the severity of gastroparesis-related symptoms. Thepresent study would also help to determine the importance of EGG in detectingdyspepsia in DM patients thereby planning a proper treatment line for thisparticular DM population. This pilot study would provide findings/abnormalitiesseen in study population and may be helpful in providing proper treatment and abetter quality of life to DM patients suffering from dyspepsia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in mean ANMS GCSI-DD score from baseline to end of the treatment that is Day 90/ Visit 5
时间窗: Baseline, Day 30, Day 60, Day 90
Change in below EGG parameters at baseline versus Visit 5- Water load volume (water load satiety test)
时间窗: Baseline, Day 30, Day 60, Day 90
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.
时间窗: Baseline, Day 30, Day 60, Day 90
Number & proportion of patients & categorization as per socio demographic & clinical profile
时间窗: Baseline, Day 30, Day 60, Day 90
次要结局
- 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))