Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia

Effects of Ondansetron on Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus and Dyspepsia

Change in severity of symptoms during enteral infusion [ Time Frame: baseline, every 15 minutes up to 8 hours ]
Visual analog scale (VAS) used to measure the change in symptom severity with a scale of 0=absent, 1=light, 2=moderate, 3=severe, 4=intolerable

Change in severity of symptoms during gastric emptying study [ Time Frame: baseline, every 15 minutes up to 2 hours ]
Visual analog scale (VAS) used to measure the change in symptom severity with a scale of 0=absent, 1=light, 2=moderate, 3=severe, 4=intolerable

Change in severity of daily symptoms [ Time Frame: Baseline, daily for six weeks ]
Gastroparesis Cardinal Symptom Index – Daily Diary (GCSI-DD) used to measure the change in symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe

Change in severity of gastrointestinal symptoms [ Time Frame: Baseline, 2 weeks, 6 weeks ]
Gastrointestinal Disorders – Symptom Severity Index (PAGI-SYM) used to measure the change in symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe

Change in severity of gastrointestinal symptoms effect on Quality of Life [ Time Frame: Baseline, 2 weeks, 6 weeks ]
Gastrointestinal Disorders – Quality of Life and Well-Being (PAGI-QOL) used to measure the change in symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe

Change in effect of Gastrointestinal symptoms on Quality of Life [ Time Frame: Baseline ]
Nepean Dyspepsia Index used to measure symptoms severity with a scale of 0=none, 1= very mild, 2=mild,3=moderate, 4=severe, 5= very severe

Source: View full study details on ClinicalTrials.gov

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May 31, 2023Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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