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CTRI Number  CTRI/2020/12/030056 [Registered on: 28/12/2020] Trial Registered Prospectively
Last Modified On: 02/09/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A survey to check knowledge, awareness, attitude and practice among doctors while prescribing antacids in acidity 
Scientific Title of Study   A prospective, cross-sectional, multicentre, observational, questionnaire-based survey to assess the Knowledge, Awareness, Attitude and Practice of physicians while prescribing proton pump inhibitor (PPI) drugs for Acid Peptic Disease. 
Trial Acronym  PPI-APD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrKranthi Kiran Pebbili 
Designation  Cluster Head – Medical Affairs 
Affiliation  Dr. Reddys Laboratories Ltd. 
Address  Dr. Reddys Laboratories Ltd. #7-1-27, Ameerpet, Hyderabad – 500016

Hyderabad
TELANGANA
500016
India 
Phone  9999536367  
Fax    
Email  kranthikiranpebbili@drreddys.com  
 
Details of Contact Person
Scientific Query  
Name  Mr Ritesh Khandelwal 
Designation  Head Clinical Research Dept.  
Affiliation  QREC Clinical Research LLP 
Address  ARG North Avenue, 113, 1st Floor, Sikar Road, Jaipur, Rajasthan – 302013

Jaipur
RAJASTHAN
302013
India 
Phone  8527566768  
Fax    
Email  bd@qreccr.com  
 
Details of Contact Person
Public Query  
Name  Mr Ritesh Khandelwal 
Designation  Head Clinical Research Dept.  
Affiliation  QREC Clinical Research LLP 
Address  ARG North Avenue, 113, 1st Floor, Sikar Road, Jaipur, Rajasthan – 302013


RAJASTHAN
302013
India 
Phone  8527566768  
Fax    
Email  bd@qreccr.com  
 
Source of Monetary or Material Support  
Dr. Reddys Laboratories Ltd. #7-1-27, Ameerpet, Hyderabad – 500016 
 
Primary Sponsor  
Name  Dr Reddys Laboratories Ltd 
Address  Dr. Reddys Laboratories Ltd. #7-1-27, Ameerpet, Hyderabad – 500016 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
Dr Kranthi Kiran Pebbili  Dr. Reddys Laboratories Ltd.  1st Floor, 2nd cubicle, Dr. Reddys Laboratories Ltd. #7-1-27, Ameerpet, Hyderabad – 500016
Hyderabad
TELANGANA 		 9999536367

kranthikiranpebbili@drreddys.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S2J Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Acidic Peptic Disease 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Physicians (doctors treating APD)meeting with following criteria
will be included in the study:
1. Doctors registered with Medical Council of India and having
MBBS Degree and above
2. Doctors having a minimum of 5 years’ experience in
clinical practice.
3. Doctors treating Acid Peptic Disease patients.
4. Doctors prescribing proton pump inhibitor (PPI) drugs
5. Doctors who are willing to voluntarily participate in the
survey and provide the consent. 
 
ExclusionCriteria 
Details  NOT APPLICABLE 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The Enumerate the below mentioned outcomes in treatment of APD:
1) Demographics of Physicians
2) patient co-morbidities and their effects
3) Role of Concomitant Medications
4) Duration of PPI administration.
5) Clinical knowledge an d Awareness of Physicians
 		 At baseline 0 DAY 
 
Secondary Outcome  
Outcome  TimePoints 
1) PPI prescription choice, dosage and duration
2) physician’s perception of different PPI’s efficacy
3) Patients PPI self-medication pattern and overall satisfaction
 		 at baseline 0 day 
 
Target Sample Size   Total Sample Size="310"
Sample Size from India="310" 
Final Enrollment numbers achieved (Total)= "116"
Final Enrollment numbers achieved (India)="116" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/12/2020 
Date of Study Completion (India) 27/04/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Study Title 

A prospective, cross-sectional, multicenter, observational, questionnaire-based survey to assess the Knowledge, Awareness, Attitude and Practice of physicians while prescribing proton pump inhibitor (PPI) drugs for AcidPeptic Disease. 

StudyObjective 

  • The main objective of the survey is to access and map the knowledge, awareness, attitude and practice of physicians while prescribing PPI for Acid Peptic Disease. 

Study Design 

  • Prospective, Cross Sectional,multicenter, Observational Survey 

Study Phase 

Not applicable  

Study Endpoints 

  • To enumerate the demographics of the physicians prescribing PPI’s for treatment of APD. 

  • To enumerate the PPI patient demographics and disposition at physician’s practice. 

  • To enumerate the patient co-morbidities and their effects on PPI prescription at physician’s practice. 

  • To identify the diagnostic workup nature followed by the physician at practice before PPI prescription and compare it with current practice guidelines recommended. 

  • To enumerate the concomitant medications utilized by APD patients at physician’s practice. 

  • To characterize the role of concomitant medications in the physician’s decision of prescribing PPI to APD patients. 

  • To enumerate other Antacids prescribed to APD patients along with PPI’s at physician’s practice. 

  • To enumerate the duration of PPI administration to patient and patient follow-up practices at physician’s practice. 

  • To enumerate the clinical knowledge and awareness of physician while choosing PPI as treatment for APD patients. 

  • To enumerate the PPI prescription choice, dosage and duration at physician’s practice. 

  • To present the physician’s perception of different PPI’s efficacy and the reasons thereof. 

  • To enumerate the factors effecting the dosage modification and substitution of PPI’s at physician’s practice. 

  • To enumerate the patient PPI self-medication pattern observed at physician’s practice. 

  • To enumerate the overall satisfaction of patients who are treated with PPI’s at physician’s practice as reported based on physician’s experience. 

  • To enumerate the perception of the physicians on the PPI effecting the efficacy or safety of the core prescription (the drugs given to treat the other chronic conditions like Diabetes, Heart Disease, Kidney disease, Lung disease, etc) 

  • To enumerate the Physician’s perception on the important patient satisfaction attributes for a PPI. 

Study population  

For Quantitative -upto 270doctors treating APD  

For Qualitative – upto 40 doctors treating APD.  

Study Procedure 

This survey will be conducted as a cross-sectional observational study on practicing physicians. The physicians (doctors treating APD) will be selected randomly from all over India for participation in the survey. A questionnaire will be designed on web-based forms and the link generated will be shared on WhatsApp groups or Emails to selected physicians (doctors treating APD) by CRO representative. The selected physicians (doctors treating APD)(participants) will be asked to fill the questionnaire after giving their consent via the weblink by clicking the “Agree to Participate” option. The Participants will be assured of the confidentiality of their information, and that it would be used only for the purpose of this study. All the participants will be asked to only fill the questionnaire once to avoid duplication of data and that their participation in the study will be entirely on voluntary basis. The responses from the online version of the questionnaire will be retrieved automatically and data used for this study will be collected and processed on SAS 9.X and statistically analyzed using descriptive statistics. 

A structured questionnaire will be used based on the variables of interest and guided by the study specific objectives. The questionnaire will consist of questions assessing demographics of physician, knowledge, awareness, attitude, practice toward usage of PPI. The questionnaire comprises of three sections, the first section to provide information to the participants about the title of the study and to obtain their consent for participation, the second section to reveal the sociodemographic details of participants and the third section has a set of questions. 

The time spent for the completion of the questionnaire will be approximately 10–20 min 

The cross-sectional survey will also comprise of qualitative assessment through interview questions which are to be answered by approx. 30 - 40 physicians(doctors treating APD). The interview questions will be asked by a representative appointed by the principal investigator and the responses will be noted down for evaluation. The time required for completion of the interview would be approximately 30 min. 

Study Selection criteria  

Inclusion Criteria: 

Physicians (doctors treating APD)meeting with following criteria will be included in the study: 

  1. Doctors registered with Medical Council of Indiaand having MBBS Degree and above  

  1. Doctors having a minimum of 5 years’ experience in clinical practice.  

  1. Doctors treating Acid Peptic Disease patients. 

  1. Doctors prescribing proton pump inhibitor (PPI) drugs  

  1. Doctors who are willing to voluntarily participate in the survey and provide the consent. 

 

Study Duration 

The Study is planned to be conducted between 1st Nov 2020 to 31st Jan 2021. 

The study is planned to be completed within 3months.  

Statistical Analysis 

Absolute (n) and relative frequencies (%) will be presented for qualitative variables and mean (±SD) will used for continuous variables. Normal distribution will be assessed by the Kolmogorov–Smirnov test. For Comparisons between groups if applicable, Student’s t-test or Mann–Whitney U test will be used according to variable distribution. Chi-squared test will be used for categorical variables. One-way analysis of variance (ANOVA) or Kruskal-Wallis will be used to compare more than two groups if applicable according to variable distribution. Statistical analysis will be performed using the SAS 9.X. Statistical significance was defined as p-value < 0.05. 

 
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