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CTRI Number  CTRI/2016/03/006763 [Registered on: 23/03/2016] Trial Registered Prospectively
Last Modified On: 20/01/2021
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 evaluate the efficacy and safety of acotiamide in indian adult patients with functional dyspepsia-post prandial distress syndrome 
Scientific Title of Study   A Phase III, Multi-Center, Open Label, Comparative, Active-Control, Parallel group, Randomized, Study to Evaluate the Efficacy and Safety of Acotiamide 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 1.1 dated 17-Nov-2015  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  Assistant General Manager 
Affiliation  Hetero Drugs Limited 
Address  “Hetero Corporate”,7-2-A2, Industrial Estates, Sanath Nagar

Hyderabad
ANDHRA PRADESH
500018
India 
Phone  91-40-23704923  
Fax  91-40-23801902  
Email  sreenivasa.chary@heterodrugs.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubhadeep Sinha MD 
Designation  Vice-President and Head 
Affiliation  Hetero Drugs Limited 
Address  “Hetero Corporate”,7-2-A2, Industrial Estates, Sanath Nagar

Hyderabad
ANDHRA PRADESH
500018
India 
Phone  91-40-23704923  
Fax  91-40-23801902  
Email  sd.sinha@heterodrugs.com  
 
Source of Monetary or Material Support  
Hetero Labs Limited, “Hetero Corporate”, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad- 500018, India Tel: 91-40-23704923/24/25; Fax: 91-40-23704926 
 
Primary Sponsor  
Name  Hetero Labs Limited 
Address  “Hetero Corporate”, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad- 500018, India Tel: 91-40-23704923/24/25; Fax: 91-40-23704926 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Upesh A Parmar MD Internal Medicine  GMERS Medical College and Hospital  GMERS Medical College and Hospital, Gotri Main Road, Gotri, Vadodara, Gujarat 390021
Vadodara
GUJARAT 		 0265-2398008

upsmd1986@gmail.com 
Dr SKGautam MBBS MD Internal Medicine  GSVM Medical College  Postgraduate Depatment Of Medicine,GSVM Medical College, Kanpur-208002,U.P.,India
Kanpur Nagar
UTTAR PRADESH 		 0512-2535483

dr_gautamhal@gmail.com 
Dr Subash Chander MD DM Gastroenterology  Marudhar Hospital  Marudhar Hospital, A-93-99, Singh Bhoomi, Khatipura, Jaipur-302012
Jaipur
RAJASTHAN 		 0141-2356944

subhashdoot@gmail.com 
Dr M Jagan Mohan MD DM Gastroenterology  New Government General Hospital  New Government General Hospital, Siddhartha Medical College Associated Hospital, Siddhartha medical college campus, Gunadala, Vijayawada-520001, Andhra Pradesh.
Krishna
ANDHRA PRADESH 		 0866-2450390

researchsmcggh14@gmail.com 
Dr K Sunil Naik  Rajiv Gandhi Institute of Medical Sciences and RIMS Govt. General Hospital  Dept. of Gen. Medicine, Rajiv Gandhi Institute of Medical Sciences&RIMS Govt.General Hospital,Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH 		 08942-279033

rimsresearch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee, Aayush Hospital  Submittted/Under Review 
Ethics Committee, G. S. V. M Medical College  Submittted/Under Review 
Ethics Committee, GMERS Medical College  Submittted/Under Review 
Ethics Committee, Marudhar Hospital  Submittted/Under Review 
Ethics Committee, Rajiv Gandhi Institute Of Medical Sciences and RIMS Government General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K30||Functional dyspepsia, (2) ICD-10 Condition: K30||Functional dyspepsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Acotiamide tablet 100 mg  Acotiamide tablet 100 mg orally three times a day before meals for 4 weeks 
Comparator Agent  Mosapride table 5 mg  Mosapride table 5 mg orally three times a day before meals for 4 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  64.00 Year(s)
Gender  Both 
Details  • The patient is willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures
• Patients with Functional Dyspepsia-Post Prandial distress syndrome (FD-PDS) as defined by the Rome III classification “(Postprandial fullness or early satiation for at least 6 months or two or more of the following symptoms at a moderate or severe level within the previous 3 months: upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiation, nausea, vomiting or excessive belching.)”
• Patients experienced two or more of the following symptoms at a moderate or severe level for 2 days or longer during the baseline period: postprandial fullness, upper abdominal bloating, or early satiety.
• If patients have coexisting epigastric pain syndrome symptoms (epigastric pain, epigastric burning), but the symptom causing the most distress at the time of obtaining informed consent had to be one of the following meal-related symptoms: postprandial fullness, upper abdominal bloating or early satiation.
• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study
• Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator 
 
ExclusionCriteria 
Details  • Patients with structural disease that is likely to explain the symptom (GERD, erosion, ulcer, hiatal hernia, bleeding, malignancy or Barretts esophagus)
• Patients have heartburn in last 12 weeks before obtaining informed consent and during the baseline period
• Patients with irritable bowel disease (IBS)
• Patients with diabetes mellitus requiring treatment
• Patients with serious anxiety disorder
• Patients with depression and/or sleep disorder
• Patients with biliary tract disease and/or pancreatitis (including chronic pancreatitis)
• Patients with presence of any symptom indicating serious or malignant disease
• Abnormality in the electrocardiogram at rest
• Hypersensitive to any of the investigational product or its components
• Currently have a clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal and/or urological disorder
• History of drug or alcohol abuse
• Currently participating in another investigational study or has participated in an investigational study within 90 days prior to randomization
• Patients with the current/past infections such as tuberculosis, herpes and/or patients with immune system disorders like HIV and SLE
• Any other disease state which could interfere with trial participation or trial evaluation as per investigator’s discretion
• Women of child-bearing potential, pregnant or lactating women, women practicing contraception by other than barrier methods or intending to donate eggs within the projected duration of the study and post-study follow-up period
• The physician is of the opinion that patient’s trial medications would put the patient at risk 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Responder rates for Overall treatment effect (OTE) by using 7-point Likert scale  Baseline to Week 4 or End of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety  Baseline to last reporting time point 
Overall treatment effect (OTE) by using 7-point Likert scale  Baseline to Weekly 
The improvement of individual symptom (upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiation, excessive belching, nausea, vomiting and heartburn) score on a severity scale of 0-3 (none, mild, moderate and severe)  Baseline to Weekly 
Assessment of the effects of treatment on disease-specific QoL by using Short Form-Nepean Dyspepsia Index questionnaire (SF-NDI)  Baseline to Week 4 or End of treatment 
Treatment emergent clinical & laboratory adverse events (TEAEs)  All time points 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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)   26/03/2016 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a phase III, open label, active control, parallel group, randomized, prospective, multicenter, efficacy, and safety study. Adult male and female (18-64 years) patients with functional dyspepsia-post prandial distress syndrome as defined by the Rome III classification, who will meet all the inclusion criteria and none of the exclusion criteria will be enrolled in the study. The randomization would be in 1:1 ratio among the study treatments. The primary objective of the study is to evaluate the efficacy of Acotiamide in patients with functional dyspepsia-post prandial distress syndrome. The secondary objective is to evaluate the tolerability and safety of Acotiamide. 
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