A Clinical Study to Test the use of Acotiamide ER300mg in stomach acidity related disorders

Phase 3

Active, not recruiting

• Conditions: Functional dyspepsia,

• Registration Number: CTRI/2019/11/021897
• Lead Sponsor: Hetero Labs Limited

Brief Summary

This is a phase III, double blind, double dummy, active control, parallel group, randomized, prospective, multicenter, efficacy and safety study. Adult male and female (18-65 years) patients with functional dyspepsia-post prandial distress syndrome (FD-PDS) as defined by the Rome IV classification, who will meet all the inclusion criteria and none of the exclusion criteria. Total study duration per patient: 1 week screening period and 4 weeks of treatment period.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-11
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

• 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

• 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.	Week 4

Secondary Outcome Measures

Name	Time	Method
Overall treatment effect (OTE) by using 7-point Likert scale	End of Every Week
Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety	Week 4
The improvement of individual symptom score on a severity scale of 0-3 (none, mild, moderate and severe)	End of Every Week

Trial Locations

Locations (4)

Grant Government Medical College and Sir JJ Group of Hospitals; 🇮🇳 Mumbai, MAHARASHTRA, India

Kanoria Hospital & Research Centre; 🇮🇳 Gandhinagar, GUJARAT, India

Maharaja Agrasen Superspeciality hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Surya Super Speciality Hospital; 🇮🇳 Varanasi, UTTAR PRADESH, India

Grant Government Medical College and Sir JJ Group of Hospitals

🇮🇳Mumbai, MAHARASHTRA, India

Dr Wagh Amol Nanasaheb MS

Principal investigator

9820685368

amolwagh@ymail.com