Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: Formulation A-FDC containing Magaldrate 480 mg,
Activated Dimethicone 50 mg, Oxetacaine 10 mg, and
Dicyclomine 10 mg per 5 mL.: Fixed Dose Combination oral suspension containing Magaldr
Sponsors
Indoco Remedies Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either gender between 18 to 60 years of age, both inclusive. 2.Patients presenting with acute gastrointestinal dyspeptic symptoms such as heartburn, regurgitation, epigastric pain or burning, bloating, belching and abdominal cramps for at least 48 hours prior to screening and enrollment. 3.Patients willing to provide written informed consent and comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with known or suspected peptic ulcer disease with alarm features such as unexplained weight loss, melena, hematemesis, gastrointestinal bleeding, or history of gastrointestinal surgery affecting motility. 2. Patients with known hypersensitivity to any component of Test or Reference product. 3. Pregnant or lactating females or female patients of childbearing potential unwilling to undergo pregnancy testing or use effective contraception, as applicable. 4. Use of other antacids, proton pump inhibitors, H2 blockers, or antispasmodics within 48 hours prior to randomization. 5. Participation in another clinical trial within 3 months prior to screening. 6. Patients with any severe concomitant illness that in the investigators opinion would interfere with study participation or outcome assessment. 7. Any other reason for which the investigator feels that the patient should not participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Proportion of patients achieving clinically meaningful symptom relief at Day 1, defined as at least a 50% reduction from baseline in the Patient Global Symptom Score (PGSS).Timepoint: At Day 1 (Visit2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first meaningful symptom relief, as reported by the patient, following administration of the first dose of study medicationTimepoint: At Day 1(Visit2);Mean change in PGSS from baseline to Day 3 and Day 5 in the two treatment groupsTimepoint: From Day 0 (Baseline) to Day 3 (Visit3) and Day 5(End of study);Proportion of patients with at least a 1-point improvement from baseline in each individual symptom score (heartburn, regurgitation, epigastric pain/burning, bloating, belching, and abdominal cramps, as applicable).Timepoint: At Day 3(Visit3) and Day 5(End of study);Number of doses of rescue medication used during the 5-day study period.Timepoint: Up to Day 5(Baseline to End of study) | — |
Countries
India
Contacts
Public ContactDr Abhijit Anil Trailokya
Indoco House, 166 CST Road, Santacruz (E)
Outcome results
None listed