FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/07/009173 [Registered on: 31/07/2017] Trial Registered Prospectively
Last Modified On: 27/09/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To compare the effects of two drugs named Acotiamide and Domperidon on the gastrointestinal symptom profile of patients with diabetes.  
Scientific Title of Study   to compare the effects of acotiamide on symptom profile and gastric emptying time with domperidone in diabetic gastroparesis: a double blind randomised control trial’ 
Trial Acronym  PGI GASTRO STUDY 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DRUSHA DUTTA 
Designation  Professor ,Adult Gastroenterology 
Affiliation  PGIMER,CHANDIGARH 
Address  Home Address: 121-A, Sector 24-A, PGI type V Quarters, Chandigarh,India

Chandigarh
CHANDIGARH
160023
India 
Phone  0172-2756610  
Fax    
Email  ushadutta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DRUSHA DUTTA 
Designation  Professor ,Adult Gastroenterology,PGIMER ,CHANDIGARH 
Affiliation  PGIMER,CHANDIGARH 
Address  Home Address: 121-A, Sector 24-A, PGI type V Quarters, Chandigarh,India

Chandigarh
CHANDIGARH
160023
India 
Phone  0172-2756610  
Fax    
Email  ushadutta@gmail.com  
 
Details of Contact Person
Public Query  
Name  DRUSHA DUTTA 
Designation  Professor ,Adult Gastroenterology,PGIMER ,CHANDIGARH 
Affiliation  PGIMER,CHANDIGARH 
Address  Home Address: 121-A, Sector 24-A, PGI type V Quarters, Chandigarh,India

Chandigarh
CHANDIGARH
160023
India 
Phone  0172-2756610  
Fax    
Email  ushadutta@gmail.com  
 
Source of Monetary or Material Support  
PGIMER CHANDIGARH 
 
Primary Sponsor  
Name  DRUSHA DUTTA 
Address  121-A, Sector 24-A, PGI type V Quarters, Chandigarh,India 160023 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DRUSHA DUTTA   PGIMER CHANDIGARH  ROOM NO.08 ,LEVEL 1,NEHRU HOPITAL ,F BLOCK, DEPTT OF GASTROENTEROLOGY
Chandigarh
CHANDIGARH 		 01722756610
01722756610
ushadutta@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEEE  Approved 
Institutional Ethics Committiee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 2 diabetic patients with minimum 5 year duration with symptoms of diabetic gastroparesis ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tab. Domperidon 10mg tds 30mins before meals  Consecutive adult patients with diabetes mellitus with cardinal symptoms of gastroparesis attending the Gastroenterology services of our institution, PGIMER, Chandigarh from july-2017 to July 2018 will be prospectively evaluated for enrolment into the study. Those fulfilling the study criteria will be recruited after a written informed consent. The study will be conducted in full compliance with the guidelines of good clinical practice of the World Medical Assembly declaration of Helsinki and the Indian Council of Medical Research guidelines. The study has been approved by the Institute’s Ethics Committee 
Comparator Agent  Tab.Acotiamide 100mg tds 30mins before meals   Consecutive adult patients with diabetes mellitus with cardinal symptoms of gastroparesis attending the Gastroenterology services of our institution, PGIMER, Chandigarh from july-2017 to July 2018 will be prospectively evaluated for enrolment into the study. Those fulfilling the study criteria will be recruited after a written informed consent. The study will be conducted in full compliance with the guidelines of good clinical practice of the World Medical Assembly declaration of Helsinki and the Indian Council of Medical Research guidelines. The study has been approved by the Institute’s Ethics Committee  
Intervention  Tab.Domperidon 10mg tds or Tab.Acotiamide 100mg tds for diabetic gastroparesis   Consecutive adult patients with diabetes mellitus with cardinal symptoms of gastroparesis attending the Gastroenterology services of our institution, PGIMER, Chandigarh from july-2017 to July 2018 will be prospectively evaluated for enrolment into the study. Those fulfilling the study criteria will be recruited after a written informed consent. The study will be conducted in full compliance with the guidelines of good clinical practice of the World Medical Assembly declaration of Helsinki and the Indian Council of Medical Research guidelines. The study has been approved by the Institute’s Ethics Committee.In this double blind double dummy trial patient will be given either domperidon or acotiamide  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  •Age above 18 years and below 65 years.
•Documented history of diabetes mellitus (type 2) for a duration of minimum 5 years.
•HbA1c 7-9gm%
•Clinical evidence of gatroparesis with symptoms of post prandial fullness, early satiety, abdominal bloating, nausea, retching, vomiting of undigested food
 
 
ExclusionCriteria 
Details  Inability to obtain informed consent
Pregnant or lactating women
Patient with thyroid dydsfunction,renal failure ,parkinsons disease ,scleroderma
Drug or alcohol abuse
UGIE showing any mechanical obstruction
Patient on GLP 1 analogues and pramlintides
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
to compare the effects of Tablet Acotiamide on Gastric emptying time in patients with diabetic gastroparesis   4week drug duration 
 
Secondary Outcome  
Outcome  TimePoints 
Gatric antral volume bu USG of gastric antrum and gall bladder ejection fraction will be calculated
 		 after 4weeks of treatment  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   31/07/2017 
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="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NONE YET  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  


 Treatment with either drug is going to improve blood sugar levels and quality of life in diabetic patients

 Patients will be regularly followed up during their one month therapy with either drug. Appearance of any untoward side effect will be taken into serious consideration. Patients will have the liberty to withdraw from the trial at any time.

 At the end of one month therapy with either drug, patients will have to undergo repeat evaluation of gastric emptying time, small bowel transit time, gastric antral volume, gall bladder ejection fraction by the same aforementioned methods for comparison of the effects of the drugs.

 Previous literature has shown the efficacy of Domperidone in diabetic gastroparesis without any serious side effect.

 On the other hand, randomized control trials involving Acotiamide have shown promising results in functional dyspepsia without any significant side effect. Adequate trials in diabetic gastroparesis are awaited.

 Assessment  and treatment of diabetic patient for gastroparesis is going to improve there quality of life and blood glucose control, So gastroparesis  requires pharmaceutical interventions for improvement of symptom profile and quality of life

 Drugs available for gastroparesis have limited efficacy  ,tachyphylaxis (decreasing response with continued use )  ,and high rate of side effect profile .So there is urgent need of some novel drug bypassing all these limitations . So, if results of Acotiamide are found to be significantly beneficial in our trial, then it can be subjected to further analysis and it may be favourable for the population at large.

 
Close