"Efficacy and Safety of Linaclotide in Chronic Constipation : A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study"
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Complete Spontaneous Bowel Movement (CSBM) responder rate
研究概览
简要总结
Goal of this study is to evaluate the efficacy and safety of two different doses of Linaclotide in improving bowel function and patient-reported outcomes among Bangladeshi patients with chronic constipation for 8 weeks along with an additional short drug-free follow up period of 2 weeks. The main question it aims to answer is "Does Linaclotide at doses of 72microgram or 145microgram once daily improve bowel function and patient-reported coutcomes compared with placebo in Bangladeshi patients with chronic constipation over an 8-week treatment period?"
Study procedure:
From outpatient department of Gastroenterology, Dhaka Medical College, a total of 90 adult patients diagnosed with chronic idiopathic constipation (CIC) or constipation predominant irritable bowel syndrome (IBS-C) by ROME-IV criteria will be selected after baseline evaluation including clinical history, physical examination, laboratory tests and colonoscopy. Before enrollment eligible participants will undergo 1-week baseline stool diary which will include baseline data of patient reported severity of abdominal symptoms (bowel movement, stool frequency, bloating, abdominal pain or discomfort and defecatory satisfaction score). Patients reporting more than 3 SBMs during baseline run in period will be excluded from the study. Finally total 90 patients will be enrolled as participants who will be randomly assigned to one of the three groups, Group A (Linaclotide 72mcg once daily), Group B (Linaclotide 145mcg once daily) and Group C (Placebo once daily ). The treatment period will start from randomization visit (day 0) and will be continued for 8 weeks. All participants will receive identical looking drugs (72mcg or 145mcg or placebo) 30 minutes before breakfast and they will be requested to maintain standard dietary and lifestyle advices including increased intake of high fiber diet and fluid throughout the study. Patients will record spontaneous bowel movement (SBM) and complete spontaneous bowel movement (CSBM), stool consistency using Bristol Stool Form Scale (BSFS), severity of abdominal symptoms by 5-point Likert scale, use of rescue medication after 3 days of absolute constipation and adverse events such as diarrhea in their daily stool diary. They will be followed up at week-4, week-8 and after 2-week drug free withdrawal period at week-10 with review of stool diary and safety assessments. Entire study will be monitored by Data Safety Monitoring Board (DSMB) of Dhaka Medical College.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18-70 years)
- •patients diagnosed with CIC or IBS-C based on Rome IV criteria
- •No abnormal finding on colonoscopy conducted within past 1 year
- •Patients who can read and are willing to complete daily bowel diary and follow study procedures
排除标准
- •Clinical features suggestive of organic disease ( Anaemia, unexplained weight loss, per rectal bleeding, family history of malignancy)
- •Secondary constipation due to structural, metabolic, or neurological causes (IBD, Colorectal cancer, hypothyroidism, hypercalcemia, DM, Parkinson's disease)
- •History of or new onset intestinal obstruction
- •Prior history of stomach, small intestine and colorectal surgery ( except appendectomy or hemorroidectomy)
- •Patients currently suffering from medication induced costipation ( opioids, anti choline raids, calcium channel blockers, oral iron and calcium supplements, anti-Parkinsonian drug, antipsychotic, anti-emetics or psychostimulant drugs)
- •Use of medication affecting bowel motility ( Lubiprostone, Elobixibat, PEG or prosecretory agents) within 2 week before enrollment
- •Serious cardiovascular, respiratory, renal, GI, hepatic, hematological, neurological or psychiatric illness
- •Pregnancy or lactation
研究组 & 干预措施
Linaclotide 72
Group A - Linaclotide 72 mcg
干预措施: Linaclotide 72 micrograms (Drug)
Linaclotide 145
Group B - Linaclotide 145 mcg
干预措施: Linaclotide 145 micrograms (Drug)
Placebo
Group C - Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Complete Spontaneous Bowel Movement (CSBM) responder rate
时间窗: 8 weeks
Complete Spontaneous Bowel Movement (CSBM) responder rate is defined as the proportion of patients achieving 3 or more complete spontaneous bowel movements (CSBM) per week with an increase of 1 or more CSBM per week from baseline for at least 6 of the treatment weeks. Patient will be maintaining a daily stool diary from which data will be obtained and CSBM responder rate will be assessed.
次要结局
- Mean change in weekly SBM frequency(8 weeks)
- Mean change in CSBM frequency(8 weeks)
- Changes in weekly stool consistency measured by Bristol Stool Form Scale (BSFS)(8 weeks)
- Change in average weekly bloating score(8 weeks)
- Change in weekly straining score(8 weeks)
- Change in weekly abdominal pain or discomfort score(8 weeks)
- Change in satisfaction score related to defecation(8 weeks)
- Patient reported adverse events(Through study completion, an average of 10 weeks)
- Sustainability of treatment effects(2 week of drug free follow up period (from week-9 to week-10))
- Potentially rebound of symptoms(2 week of drug free follow up period (from week-9 to week-10))
研究者
Md Mehedi Shahriar
Principal investigator
Dhaka Medical College