A Clinical Study to Test the use of Acotiamide ER300mg in stomach acidity related disorders
- Conditions
- Health Condition 1: K30- Functional dyspepsia
- Registration Number
- CTRI/2019/11/021897
- Lead Sponsor
- Hetero Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Responder rates by Overall treatment effect (OTE) by using 7-point Likert scale at the End of Treatment visit.Timepoint: Week 4
- Secondary Outcome Measures
Name Time Method 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