A Clinical Trial to Evaluate the Efficacy and Safety of Plecanatide in Subjects with Chronic Idiopathic Constipation or Irritable Bowel Syndrome with Constipation.
- Conditions
- Health Condition 1: K581- Irritable bowel syndrome with constipation
- Registration Number
- CTRI/2022/03/040704
- Lead Sponsor
- MSN Laboratories Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: Baseline, Week 1, Week 6, Week 12
- Secondary Outcome Measures
Name Time Method Frequency of rescue therapy (bisacodyl) used per week for constipation.Timepoint: 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.Timepoint: week 1, week 6 and week 12;Improvement in weekly average score of stool consistency from baseline to Week 12 using Bristol Stool Form scale.Timepoint: Baseline, Week 1, Week 6, Week 12;Improvement in weekly average score of straining from baseline to week 12 using 11-point scale.Timepoint: Baseline, Week 1, Week 6, Week 12;Proportion (%) of bowel movements with incomplete evacuation/weekTimepoint: Baseline, Week 1, Week 6, Week 12