CTRI/2023/05/052685进行中（未招募）Unknown
A Randomized, Double-blinded, Parallel, Placebo-controlled, Multicenter, bioequivalence study with clinical endpoint to assess efficacy and safety of Linaclotide 145 mcg capsule (manufactured by Arab Pharmaceutical Manufacturing PSC, Jordan for Hikma Pharmaceuticals (MAH)) to LINZESS® (linaclotide) 145 mcg capsules (Allergan USA, Inc. Madison, NJ 07940) in the treatment of chronic idiopathic constipation. - 22-VIN-0003
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
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
- •Brief inclusion as below,
- •1. Male or female more than and equal to 18 years with a clinical diagnosis of chronic idiopathic constipation (CIC).
- •2. Ability to provide written informed consent for the study.
- •3. Have 1 or more of the following symptoms related to bowel movements:
- •Lumpy or hard stools for more than 25% of the bowel movements
- •Sensation of incomplete evacuation following more than 25% of the bowel movements.
- •Straining at defecation more than 25% of the time.
- •4. Meet the colonoscopy requirements defined by the American Gastroenterological Association (AGA) guidelines.
- •5. Willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-defined Rescue Medicine.
- •6. Agree to refrain from making any new major lifestyle changes that may have affected CIC symptoms from the time of screening to the last trial visit.
- •7. Free from any clinically significant disease.
- •8. Comply with protocol & Investigator visit requirements.
排除标准
- •1. Pregnant, breastfeeding, or planning a pregnancy.
- •2. Subject with evidence of weight loss, anemia, or rectal bleeding or documented colonoscopy performed during the 6 months prior to dosing.
- •3. Documented mechanical bowel obstruction, megacolon/megarectum, or diagnosis of pseudo-obstruction.
- •4. GI track Structural abnormality or a disease or condition that could affect GI motility
- •5. Fecal impaction that required hospitalization or emergency room treatment, or had a history of cathartic colon, laxative or enema abuse, ischemic colitis, or pelvic floor dysfunction.
- •6. Meet the Rome IV criteria for Irritable Bowel Syndrome or Opioid-Induced Constipation.
- •7. Diagnosis or family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer.
- •8. Current active peptic ulcer disease
- •9. History of diabetic neuropathy, diverticulitis or any chronic condition that could be associated with abdominal pain or discomfort
- •10. History of Bariatric surgery or surgery to remove a segment of the GI tract 6 months before the Screening Visit, major surgery within 4 weeks prior to study, an appendectomy or cholecystectomy during the 60 days before the Screening Visit, or other major surgery during the 30 days before the Screening Visit.
- •11. Potential central nervous system cause of constipation
- •12. Untreated hypothyroidism or treated hypothyroidism for which the dose of thyroid hormone had not been stable for at least 6 weeks at the time of the Screening Visit
- •13. Hospitalized for any gastrointestinal or abdominal surgical procedure during the 3 months prior to dosing.
- •14. Clinically significant cardiovascular, liver, lung, neurologic, renal or psychiatric disorder, or hematologic and/or biochemical abnormalities based on laboratory testing.
- •15. Used Rescue Medicine or any other laxative, suppository, or enema, on the calendar day before or the calendar day of the start of the Treatment Period.
- •16. Reported using a Prohibited Medicine during the Pretreatment Period or was not willing or able to abide by the restrictions regarding use of Prohibited Medicines
- •17. Any other conditions, including severe illness, which would make the patient, in the opinion of the Investigator, unsuitable for the study.
- •18. Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery.
- •19. Positive for drugs of abuse or Breath alcohol analyzer test prior to receiving the first dose/baseline of the investigational medicinal product in the study.
- •20. Patients found positive for HIV, Syphilis, Hepatitis B surface antigen or Hepatitis C antibody at screening.
- •21. Receipt of an investigational medicinal product or participation in another drug research study within 30 Days.
研究者
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