Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: Tablet - Acotiamide ER 300 mg: Tablet – Acotiamide ER 300 mg and Placebo 100 mg in the
morning
Tablet – Placebo 100 mg in the evening and night
Dosage: (2 tablets + 1 tablet + 1 tablet)
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female patients of 18 – 65 years age 2. The patient is willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures 3. Patients with Functional Dyspepsia – Post Prandial Distress Syndrome (FD-PDS) as defined by the Rome IV classification 4. Females of childbearing potential who are sexually active must agree to use barrier contraceptives 5. Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range
Exclusion criteria
Exclusion criteria: 1. Evidence of organic, systemic, or metabolic disease that is likely to explain the symptoms 2. Patients on any anti-secretory drugs, antacids, prokinetics, nonsteroidal anti-inflammatory drugs and antidepressant drugs 3. Patients with Hemoglobin levels less than 9 gm/dl requiring oral or/and parenteral treatment 4. Patients with presence of any symptom indicating serious or malignant disease 5. Hypersensitive to any of the investigational product or it’s components 6. Patients with past or current HIV, HBV and HCV positive 7. History of alcohol abuse within the past 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder rates by Overall treatment effect (OTE) by using 7-point Likert scale at the End of Treatment visit.Timepoint: Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Elimination rate of post-prandial fullness, upper abdominal bloating and early satietyTimepoint: Week 4;Overall treatment effect (OTE) by using 7-point Likert scaleTimepoint: End of Every Week;The improvement of individual symptom score on a severity scale of 0-3 (none, mild, moderate and severe)Timepoint: End of Every Week | — |
Countries
India
Contacts
Public ContactDr SD Sinha
Hetero Labs Limited
Outcome results
None listed