CTRI/2022/03/040704已完成3 期
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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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).
排除标准
- •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
- •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.
研究者
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