CTRI/2023/03/050482招募中3 期
A RANDOMIZED, MULTICENTRE, DOUBLE BLIND, PLACEBO CONTROLLED,PARALLEL-GROUP, STUDY TO EVALUATE THE EFFICACY AND SAFETY OFLINACLOTIDE ONCE DAILY OF DR. REDDY’S LABORATORIES LIMITED INPATIENTS WITH CHRONIC CONSTIPATIO
试验速览
- 阶段
- 3 期
- 状态
- 招募中
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 patients of 18-65 years age
- •2. Ambulatory patients with chronic constipation (Fulfilling Rome IV criteria) reporting less than 3 Spontaneous
- •Bowel Movements (SBM) per week and reports one or more of the following symptoms for the last 3 months with symptom onset at least 6 months before the Screening Visit or before starting chronic therapy with any laxative:
- •? Straining during more than 25% of defecations
- •? Lumpy or hard stools more than 25% of defecations
- •? Sensation of incomplete evacuation more than 25% of defecations
- •3. Patients with less than 3 CSBM per week during pretreatment period.
- •4. Willing to comply with protocol requirements and sign a statement of informed consent
- •5. Willing to discontinue any laxatives used before the Pretreatment period in favor of the protocol-defined Rescue Medicine (bisacodyl Capsules or suppositories)
- •6. Agreed to refrain from making any new, major lifestyle changes that may have affected CIC symptoms (e.g., starting a new diet or changing his or her exercise pattern) from the time of signature of the ICF to the last trial visit.
- •7. Female subjects of child-bearing potential should have negative serum pregnancy test at screening and agree to use adequate birth control during the entire study period.
- •Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject).
- •Postmenopausal for at least 1 year
排除标准
- •1. Pregnant, breast feeding, or planning a pregnancy
- •2. Subject of any age with evidence of clinically significant weight loss, or rectal bleeding and without documentation of the results of either a flexible sigmoidoscopy or colonoscopy performed within 2-years period prior to screening.
- •3. Reports loose (mushy) or watery stools in the absence of any laxative intake in the form of a Capsule, a suppository or an enema, or prohibited medicine for greater than 25% of bowel movements
- •4. Reported a Bristol Stool Form Scale score of 6 (loose, mushy stools) for greater than 1 SBM or a Bristol Stool Form Scale score of 7 (watery stools) with any SBM over the 2 weeks pretreatment period before the Randomization Visit [Refer to appendix 3 for BSFS scale].
- •5. Received a diagnosis of inflammatory bowel disease (IBD)
- •6. Meet the Rome IV criteria for Irritable Bowel Syndrome (IBS) or the Rome IV criteria for Opioid-Induced Constipation (OIC).
- •7. Has a history of structural abnormality of the Gastrointestinal (GI) tract or a disease or condition that can affect GI motility
- •8. Has a history of diverticulitis, chronic pancreatitis, active peptic ulcer disease (PUD) not adequately treated, ischaemic colitis, inflammatory bowel disease, laxative abuse, faecal impaction that required hospitalization or emergency treatment, pseudo-obstruction, mega colon, mega rectum, bowel obstruction, descending perineum syndrome, ovarian cysts, endometriosis, solitary rectal ulcer syndrome, systemic sclerosis, pre-malignant colonic disease (e.g., familial adenomatous polyposis or hereditary non-polyposis colorectal cancer) or other forms of familial colorectal cancer.
- •9. Diagnosis or family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer
- •10. Current active peptic ulcer disease (i.e., disease that was not adequately treated or stable with therapy)
- •11. Has unexplained and clinically significant GI alarm signals (e.g., lower GI bleeding or heme-positive stool in the absence of known internal or external haemorrhoids, iron-deficiency anaemia, unexplained weight loss) or systemic signs of infection or colitis.
- •12. Patients who require chronic diuretic treatment
- •13. Has clinically significant laboratory findings or medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator.
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