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CTRI Number  CTRI/2019/11/021897 [Registered on: 06/11/2019] Trial Registered Prospectively
Last Modified On: 05/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Study to Test the use of Acotiamide ER 300mg in stomach acidity related disorders 
Scientific Title of Study   A Phase III, Multi-Center, Double blind, Comparative, Active-Control, Parallel group, Randomized, Study to Evaluate the Efficacy and Safety of Acotiamide ER 300mg in Indian Adult Patients with Functional Dyspepsia-Post Prandial Distress Syndrome 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HCR/III/ACOFD-PDS/01/2015, Version 1.0 dated 18 Jan 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Dr Sreenivasa Chary 
Designation  Deputy General Manager 
Affiliation  Hetero Labs Limited 
Address  CDMA Department, 2nd Floor, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar

Hyderabad
TELANGANA
500018
India 
Phone  04023704923  
Fax    
Email  sreenivasa.chary@heterodrugs.com  
 
Details of Contact Person
Public Query
 
Name  Dr SD Sinha 
Designation  Sr. Vice President 
Affiliation  Hetero Labs Limited 
Address  CDMA Department, 2nd Floor, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar

Hyderabad
TELANGANA
500018
India 
Phone  04023704923  
Fax    
Email  sd.sinha@heterodrugs.com  
 
Source of Monetary or Material Support  
Hetero Labs Ltd; 7-2-A2 Industrial Estates, Sanath Nagar; Hyderabad – 500 018, Telengana, India Phone no: 040 23704923 
 
Primary Sponsor  
Name  Hetero Labs Limited 
Address  7-2-A2 Industrial Estates, Sanath Nagar; Hyderabad – 500 018, Telengana, India Phone no: 040 23704923  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Wagh Amol Nanasaheb MS  Grant Government Medical College and Sir JJ Group of Hospitals  OPD 20, Department of General surgery, Old OPD Building, Byculla,Mumbai-400008
Mumbai
MAHARASHTRA 
9820685368

amolwagh@ymail.com 
Dr Jitendra Anand MD  Kanoria Hospital & Research Centre  Department of Medicine, Ground Floor, Room no 2, Airport Gandhinagar Highway, Vil: Bhat Gandhinagar-382428
Gandhinagar
GUJARAT 
9824517101

jkanand09@gmail.com 
Dr Subhash chander MD  Maharaja Agrasen Superspeciality hospital  Basement Room No 209, Central spine, Agrasen Aspatal Marg, sector 7, Vidhyanagar, Jaipur-302039
Jaipur
RAJASTHAN 
9828511073

subhashdoot@gmail.com 
Dr Shekhar Puri MD DMGastroenterology  Surya Super Speciality Hospital  Ground Floor, Department of Medicine, A Unit of G.V. Meditech(P) Ltd, B 38/46 H Raman Niwas, Mahmoorganj, Varanasi-221010
Varanasi
UTTAR PRADESH 
9794596131

drshekhar12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
G.V. Meditech Ethics Committee, G.V. Meditech Pvt Ltd, B 38/46 H Raman Niwas, Mahmoorganj, Varanasi-221010, UP, India ECR/14/Inst/UP/2013-RR-16  Approved 
Institutional Ethics Committee, Grant Government Medical College and Sir JJ Group of Hospitals, Byculla Mumbai-400008, Maharashtra, India ECR/382/INST/MH/2013/RR-16  Approved 
Institutional Ethics Committee, Maharaja Agrasen Hospital, Maharaja Agrasen Superspeciality Hospital, Central Spice, Agrasen Aspatal Marg, Sector-7, Vidyadhar nagar, Jaipur. ECR/1222/Inst/RJ/2019.  Approved 
Kanoria Ethics Committee, Kanoria Hospital & Research Centre, Airport-Gandhinagar Highway, Village-Bhat, Gandhinagar, Gujarat-382428 ECR/620/Inst/GJ/2014/RR-17  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K30||Functional dyspepsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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) – Three time a day before meals for 4 weeks. 
Comparator Agent  Tablet – Acotiamide 100 mg  Tablet – Acotiamide 100 mg and Placebo 300 mg in the morning Tablet – Acotiamide 100 mg in the evening and night Dosage: (2 tablets + 1 tablet + 1 tablet) - Three times a day before meals for 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Responder rates by Overall treatment effect (OTE) by using 7-point Likert scale at the End of Treatment visit.  Week 4 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="212"
Sample Size from India="212" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   09/11/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.
 
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