Health Condition 1: K30- Functional dyspepsia Health Condition 2: K219- Gastro-esophageal reflux disease without esophagitis Health Condition 3: null- Non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD)
Conditions
Interventions
Intervention1: Clebopride malate (Clebopride 0.5 mg) tablets: Thrice daily for 4 weeks
Control Intervention1: Itopride hydrochloride 50 mg tablets: Thrice daily for 4 weeks
Sponsors
Cadila Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either sex more than or equal to 18 years of age (no upper age limit was mentioned in our Protocol for this clinical trial). 2.Established diagnosis of non-ulcer dyspepsia (NUD) or gastroesophageal reflux disease (GERD) with gastrointestinal symptoms of at least moderate intensity. 3. Normal routine hematological and biochemical test results. 4. Informed consent of the patient / relative.
Exclusion criteria
Exclusion criteria: 1. Pregnancy and/or Lactation. 2. Patients with an increased gastrointestinal motility e.g. in patients with gastrointestinal hemorrhage, mechanical obstruction or perforation. 3. Patients with ulcerative dyspepsia and/or ulcerative gastritis. 4. Patients with severe cardiac, pulmonary, hepatic or renal disease. 5. Patients on concomitant medications known to prolong QT interval. 6. Patients on concomitant medications known to affect action of Clebopride malate like anticholinergic agents such as scopolamine, psychotropic drugs, other dopaminergic agents, or hormones. 7. Patients with known hypersensitivity to Clebopride malate, Itopride hydrochloride or any other prokinetic agents. 8. Patients with any other serious concurrent illness or malignancy. 9. Patients with continuing history of alcohol and / or drug abuse. 10. Participation in another clinical trial in the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the mean intensity score of the symptoms (overall and individual) at the end of the study (Week 4) as compared to the baseline (prior to initiation of the therapy i.e. Week 0)Timepoint: 1,2,3 & 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Improvement in the mean intensity score of the symptoms (overall and individual) as estimated on a weekly basis. (2) Percentage of patients experiencing complete resolution of symptoms of reduced gastrointestinal motility at the end of the study i.e. 4 weeks. (3) Percentage of patients having endoscopic healing on upper G.I. endoscopy, if done. (4) Overall assessment of efficacy to the study medication at the end of the study.Timepoint: 1,2,3 & 4 weeks | — |
Countries
India
Contacts
Public ContactDr Ravindra Mittal
Outcome results
None listed