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CTRI Number  CTRI/2022/03/040704 [Registered on: 02/03/2022] Trial Registered Prospectively
Last Modified On: 22/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Clinical Trial to Evaluate the Efficacy and Safety of Plecanatide in Subjects with Chronic Idiopathic Constipation or Irritable Bowel Syndrome with Constipation. 
Scientific Title of Study   A Randomized, Double-Blind, Multicentric, Placebo-Controlled, Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of Plecanatide in Subjects with Chronic Idiopathic Constipation or Irritable Bowel Syndrome with Constipation. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CT/ND/194/2021  DCGI 
PLEC/MSN/P3/2021, Version 2.0, Dated 06 Jan 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aditi Datta  
Designation  Managing Director  
Affiliation  Biosite Research Private Limited  
Address  Office No 81, 82, 83 & 84 3rd Floor Chandru Complex, 18th Main, RBI Layout, JP Nagar Phase 7, Bangalore

Bangalore
KARNATAKA
560061
India 
Phone  0919811788955  
Fax    
Email  aditi.datta@biositeindia.com  
 
Details of Contact Person
Scientific Query  
Name  K Ravinder Reddy 
Designation  GM Indian Regulatory Affairs 
Affiliation  MSN Laboratories Private Limited 
Address  Plot No C-24, MSN House, Industrial Estate, Sanath Nagar, Hyderabad

Hyderabad
TELANGANA
500018
India 
Phone  04030438712  
Fax  04030438667  
Email  krreddy@msnlabs.com  
 
Details of Contact Person
Public Query  
Name  Dr Aditi Datta  
Designation  Managing Director  
Affiliation  Biosite Research Private Limited  
Address  Office No 81, 82, 83 & 84 3rd Floor Chandru Complex, 18th Main, RBI Layout, JP Nagar Phase 7, Bangalore

Bangalore
KARNATAKA
560061
India 
Phone  0919811788955  
Fax    
Email  aditi.datta@biositeindia.com  
 
Source of Monetary or Material Support  
MSN Laboratories Private Limited, MSN House, Plot No C-24,Industrial Estate, Sanathnagar,Hyderabad-500018, Telangana, India. 
 
Primary Sponsor  
Name  MSN Laboratories Private Limited 
Address  MSN House, Plot No C-24, Industrial Estate, Sanathnagar, Hyderabad-500018, Telangana, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ravi Daswani  Abhinav Multispeciality Hospital,  Nayanakasha, Kamal Chowk, Nagpur - 440017
Nagpur
MAHARASHTRA 		 9711699321

abhinavhospitalres13@gmail.com 
Dr Abhijit Karad  B.J. Govt. Medical College and Sasoon General Hospitals  Department of Gastroenterology, B.J. Govt. Medical College and Sasoon General Hospitals, Pune - 411001
Pune
MAHARASHTRA 		 9823055395

karad_abhijeet@yahoo.com 
Dr Diptak Bhowmick  College of Medicine and Sagore Dutta Hospital  578, B.T. Road, Kamarhatti, Kolkata-700058
Kolkata
WEST BENGAL 		 8777047635

diptak86@gmail.com 
Dr Omesh Goyal  Dayanand Medical College and Hospital  Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana
Ludhiana
PUNJAB 		 9914821155
0161-2302620
drgoyaldmc@gmail.com 
Dr R K Jauhari  G.S.V.M. Medical College  Department of Surgery, Kanpur, GSVM Medical College, Swaroop Nagar, Kanpur-208002.
Kanpur Nagar
UTTAR PRADESH 		 9453574632

dr_ramendra@yahoo.com 
Dr S S V V Narasinga Rao  Government of Medical College and Government College hospital  Department of Medicine, Government of Medical College and Government College hospital, Srikakulam
Srikakulam
ANDHRA PRADESH 		 9908611119

drnarasingaraossvv@yahoo.com 
Dr Bhumit Patel  Kanoria Hospital and Research Centre  Airport-Gandhinagar, Highway, Village Bhat, Dist-Gandhinagar 382428
Gandhinagar
GUJARAT 		 8412883230

bhumitpatel82@gmail.com 
Dr Vivek Bhatia  Maharaja Agrasen Hospital  Department of Gastroenterology, Maharaja Agrasen HospitalBlock C, Shivaji Park, West Punjabi Bagh - Delhi 110026
West
DELHI 		 9811028897

drvivekbhatia@yahoo.co.in 
Dr Pinaki Roy  NRS Medical College and Hospital  138, A.J.C Bose Road, Kolkata - 700014
Kolkata
WEST BENGAL 		 09474891727

drpinaki1979@gmail.com 
Dr Rajesh Pendalimari  Rajalakshmi Hospital & Research Center  Dept. of General medicine, Ground floor, Room Number 1, 21/1, Lakshmipura Main Road, Vidyaranyapura Post Bangalore- 560097
Bangalore
KARNATAKA 		 9553252525

pendlimari.rajesh@gmail.com 
Dr Prasanna Basavarajappa  Subbaiah Institute of Medical Sciences   Department of Gastroenterology, Subbaiah Institute of Medical Sciences NH-13,HH Road Purle, Shivamogga -577202
Shimoga
KARNATAKA 		 9900402806

prasisibaka@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Drug trial Ethics Committee Dayanand Medical College and Hospital  Approved 
Ethics Committee Subbaiah Institute of Medical Sciences  Approved 
Ethics Committee B J Medical College and SGH B J Medical College and Sassoon General Hospital  Approved 
Ethics Committee GSVM Medical College  Submittted/Under Review 
Ethics Committee, N.R.S. Medical College  Submittted/Under Review 
HCG NCHRI CANCER CARE ETHICS COMMITTEE  Approved 
Institutional Ethics Committee College of Medicine and Sagore Dutta Hospital  Submittted/Under Review 
Institutional Ethics Committee Rajalakshmi Hospital & Research Center  Approved 
Institutional Ethics Committee, Government of Medical College and Government General Hospital  Approved 
Institutional Ethics Committee, Maharaja Agrasen Hospital  Submittted/Under Review 
Kanoria Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K581||Irritable bowel syndrome with constipation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo with Matching Plecanatide Tablets 3mg   Subjects will take Placebo (matching with test product) tablets once a day orally after meal for a period of 12 weeks (84±1 days). 
Intervention  Plecanatide 3mg Tablet  Subjects will take Plecanatide 3mg Tablet once a day orally after meal for a period of 12 weeks (84±1 days). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or female subjects having age 18 years to 65 years.

2. Subject and/or his/her legally accepted representative willing to give written informed
consent.

3. Subjects with a diagnosis of chronic idiopathic constipation as per Rome IV criteria.
According to the Rome IV criteria for constipation, a patient must have experienced
at least two of the following symptoms over the preceding three months with symptom
onset at least 6 months prior to diagnosis:
i) Fewer than three spontaneous bowel movements per week.
ii) Straining for more than 25% of defecation attempts.
iii)Lumpy or hard stools for at least 25% of defecation attempts
iv) Sensation of anorectal obstruction or blockage for at least 25% of defecation attempts.
v) Sensation of incomplete defecation for at least 25% of defecation attempts.
vi) Manual manoeuvring required to defecate for at least 25% of defecation attempts.

4. History of poor results with laxative treatment and diet counselling (Subjects on a stable diet regimen at the time of screening visit and are willing to continue the same diet for the the entire duration of the study).

5. Subjects who report fewer than three complete spontaneous bowel movement (CSBMs) per week during pre-treatment period of 2 weeks after screening (verified at the time of enrolment visit).
 
 
ExclusionCriteria 
Details  1. Subject with history of hypersensitivity to Plecanatide or to any of the excipient.

2. Subject with mechanical bowel obstruction, megacolon/megarectum, or diagnosis of pseudo-obstruction. (as per documented colonoscopy).

3. Subjects with known or suspected organic disorders of the large or small bowel (e.g.,
inflammatory bowel disease like ulcerative colitis, Crohn’s Disease).

4. Subjects with history of weight loss 10% of body weight over a period of 6 months.

5. Subjects having history of anemia and hemoglobin (Hb) ≤12.5 gm/dl for male or Hb ≤12
gm/dl for female at screening laboratory investigation.

6. Subjects on treatment with drugs which are likely to cause constipation e.g., tricyclic
antidepressants, anticholinergics, narcotic analgesics or calcium channel blockers.

7. Subjects with active peptic ulcer.

8. Subject with history of bowel resection or rectal bleeding.

9. Subject with history of Hospitalization for any gastrointestinal or abdominal surgical
procedure during the 3 months prior to screening.

10. Subjects with TSH ≥6 µIU/ml or symptoms of hyperthyroidism or hypothyroidism and the
same confirmed with laboratory investigation.

11. Subjects with clinically significant ECG abnormalities.

12. Clinically significant medical disorder or clinically significant abnormal laboratory finding.

13. History of faecal impaction that required hospitalization or has a history of laxative or
enema abuse, ischemia colitis and pelvic floor dysfunction.

14. Subjects with liver enzymes (ALT and AST) more than 2.5 times the normal value and/or
bilirubin more than 1.5 times the normal value.

15. Subject with Serum creatinine more than upper limit of normal value (UNL).

16. Subject with history of malignancy except basal cell carcinoma.

17. Pregnant or lactating women.

18. Female subjects who are of childbearing potential and who are neither surgically sterilized
nor willing to use reliable contraceptive methods (hormonal, barrier methods or intrauterine
device).

19. Subject with history of alcohol or drug abuse in the opinion of the investigator.

20. Participation in any clinical study during last three months.

21. Subjects with suspected signs and symptoms of COVID-19/confirmed novel coronavirus
infection (COVID-19) or with a recent history of travel/contact with any COVID-19 positive
subject /isolation/quarantine in the last 14 days based on investigator’s discretion. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion (%) of the subjects having an average of at least three or more complete spontaneous bowel movements (CSBMs)/week over the 12 weeks of the treatment period.  Baseline, Week 1, Week 6, Week 12 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in weekly average score of straining from baseline to week 12 using 11-point scale.  Baseline, Week 1, Week 6, Week 12 
Improvement in weekly average score of stool consistency from baseline to Week 12 using Bristol Stool Form scale.  Baseline, Week 1, Week 6, Week 12 
Proportion (%) of bowel movements with incomplete evacuation/week  Baseline, Week 1, Week 6, Week 12 
Frequency of rescue therapy (bisacodyl) used per week for constipation.  Baseline, Week 1, Week 6, Week 12 
Improvement in Investigator’s global assessment of efficacy at week 1, week 6 and week 12 using 5-point scale.  week 1, week 6 and week 12 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
Final Enrollment numbers achieved (Total)= "208"
Final Enrollment numbers achieved (India)="210" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   05/03/2022 
Date of Study Completion (India) 28/06/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
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  
This will be a double blind, prospective, study to evaluate safety and efficacy of Plecanatide in subjects with chronic idiopathic constipation or irritable bowel syndrome with constipation. Initially subjects will be screened as per predefined eligibility criteria for the study. Eligible 210 subjects will be enrolled to receive either Plecanatide or placebo.
Subjects will be randomized in 2:1 ratio. Group 1 will have 140 subjects and Group 2 will have 70 subjects.
Group 1 (Treatment group): Plecanatide.
Group 2 (Control group): Placebo

The study will involve screening (Day -14), treatment period of up to maximum 12 weeks till end of study. The investigator shall make every effort to follow the schedule of study assessments and procedures. A window period of ±1 day will be allowed for assessments post randomization.

Screening:
Upon obtaining the written informed consent the subjects will be screened to confirm the eligibility for participating in this study. Subjects will undergo 14 days of pretreatment where they will record number of spontaneous bowel movements and use of rescue medication during this period. In baseline visit (Day 0) randomization will be performed.

Treatment period:
Subjects will receive investigational product Plecanatide or placebo after randomization as per protocol.
 
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