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 CONSTIPATION
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 316
- 试验地点
- 25
- 主要终点
- Change from baseline to week 12 of Complete Spontaneous Bowel Movement (CSBM).
研究概览
简要总结
Constipation is used to describe symptoms that relateto difficulties in defecation. Chronic constipation is generally defined bysymptoms that persist for at least 3 months. Chronicconstipation (CC) is a highly prevalent condition affecting between 12% to 19% of the population. Laxatives are being commonly prescribed for the management ofchronic constipation.However, concerns such as inadequate response,persistence of symptoms, adverse effects remain some important challenges withthe available treatment options. Further, patients with CC sufferfrom a range of bowel symptoms of varying severities, may requireindividualized approaches to the management of their symptoms, may differ intheir responsiveness to various treatments.
Linaclotideis an already approved drug by USFDA since 2012 for patients with chronicconstipation and irritable bowel syndrome. Linaclotide is structurally related to human guanylinand uroguanylin and functions as a guanylate cyclase-C (GC-C) agonist.
Thisclinical trial is a prospective, multicenter, randomized, double-blind,parallel-group, placebo-controlled study which will be conducted to evaluatethe efficacy, and safety of Linaclotide in patients with chronic constipation.The trial consists of up to 28 days of screening (including 14 days ofpre-treatment period), and 12 weeks of double-blind treatment.
In the clinical trials, Linaclotide showed a favourable safety andefficacy profile w.r.t stool consistency, straining,constipation severity, abdominal discomfort, and bloating which mayprove to be beneficial for the patients with Chronic constipation. This studyis being conducted to generate the data regarding the efficacy and safety ofLinaclotide in Indian population. An unmet need for drugs exists despite theavailability of different treatment options for constipation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients of 18-65 years age
- •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: ï‚· Straining during more than 25% of defecations ï‚· Lumpy or hard stools more than 25% of defecations ï‚· Sensation of incomplete evacuation more than 25% of defecations
- •Patients with less than 3 CSBM per week during pretreatment period.
- •Willing to comply with protocol requirements and sign a statement of informed consent
- •Willing to discontinue any laxatives used before the Pretreatment period in favor of the protocol-defined Rescue Medicine (bisacodyl Capsules or suppositories)
- •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.
- •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.
- •OR Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subject).
- •OR Postmenopausal for at least 1 year.
排除标准
- •Pregnant, breast feeding, or planning a pregnancy
- •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.
- •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
- •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].
- •Received a diagnosis of inflammatory bowel disease (IBD)
- •Meet the Rome IV criteria for Irritable Bowel Syndrome (IBS) or the Rome IV criteria for Opioid-Induced Constipation (OIC).
- •Has a history of structural abnormality of the Gastrointestinal (GI) tract or a disease or condition that can affect GI motility
- •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.
- •Diagnosis or family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or any other form of familial colorectal cancer
- •Current active peptic ulcer disease (i.e., disease that was not adequately treated or stable with therapy)
- •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.
- •Patients who require chronic diuretic treatment
- •Has clinically significant laboratory findings or medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator.
结局指标
主要结局
Change from baseline to week 12 of Complete Spontaneous Bowel Movement (CSBM).
时间窗: 12 Weeks
次要结局
- 1. Change from baseline in 12 week CSBM frequency rate(2. Change in weekly SBM frequency rate from baseline)