NCT03054506已完成不适用
A Randomized, Single Center, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change From Baseline in Colonic Transit Time (CTT)
研究概览
简要总结
Constipation is a common gastrointestinal motility disorder that is often chronic, negatively affects patients' daily lives. Constipation occurs when bowel movements become difficult or less frequent.This study is being done to study the effectiveness of the hydrogel capsule, CSP01, compared to the active control (carboxymethylcellulose) and placebo (non-medicine sugar pill), to relieve constipation among subjects with chronic idiopathic constipation (CIC) or with irritable bowel syndrome with constipation (IBS-C).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22-70 years old
- •BMI >18.5 and <35 kg/m2
- •Rome III criteria for functional constipation or IBS-C
- •Continued IBS-C or CIC throughout Run-in period
- •Compliant with reporting during Run-in (confirm the presence of constipation during the 7-day Run-in baseline period; patients are required to report an average of <3 continuous spontaneous bowel movements [CSBMs] and ≤6 spontaneous bowel movements [SBMs] per week via the interactive web response system).
- •Ability to follow verbal and written instructions
- •Ability to record daily bowel habits, including frequency, stool consistency (BSFS), straining (EoPS), completeness of evacuation, and Patient Reported Outcomes (PROs) (abdominal discomfort, severity of constipation, bloating, overall relief)
- •Informed consent form signed by the subjects
排除标准
- •History of loose stools
- •History of irritable bowel syndrome with diarrhea (IBS-D) or mixed irritable bowel syndrome (IBS-M)
- •Non-compliance with reporting during Run-in
- •Patients reporting laxative, enema, and/or suppository usage for >2 days or any usage of a prohibited medication during the Run-in period
- •Patients reporting watery stools for any SBM (Type 7 on the Bristol Stool Form Scale [BSFS]) or loose (mushy) stools for >1 SBM (Type 6 on the BSFS) in the absence of laxatives during Run-in
- •GI motility obstruction or GI tract structural abnormality
- •Current use of prescribed or illicit opioids
- •History of pelvic floor dysfunction
- •Need for manual maneuvers in order to achieve a BM
- •History of GI lumen surgery at any time or other GI or abdominal operations within 60 days prior to entry into the study
- •History of high-dose stimulative or cathartic laxative abuse as judged by investigator team
- •Neurological disorders, metabolic disorders, or other significant disease that would impair their ability to participate in the study
- •Cardiovascular disease, diabetes, cancer, Crohn's disease, ulcerative colitis
- •BMI of <18.5 or >35 kg/m2
- •Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) or lactation
- •Absence of contraception in females of childbearing potential
- •History of allergic reaction to carboxymethylcellulose, citric acid, sodium stearyl fumarate, raw cane sugar, gelatin, or titanium dioxide
- •Administration of investigational products within 1 month prior to Screening Visit
- •Exclusion of colonic inertia with symptoms of < 1 BM per 2 weeks
- •Subjects anticipating surgical intervention during the study
- •Known history of diabetes (type 1 or 2)
- •History of eating disorders including binge eating (except mild binge eater)
- •Supine SBP > 160 mm Hg and/or supine DBP > 95 mm Hg (mean of two consecutive readings)
- •Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
- •History of swallowing disorders
- •Esophageal anatomic abnormalities (e.g., webs, diverticuli, rings)
- •History of gastric bypass or any other gastric surgery
- •History of small bowel resection (except if related to appendectomy)
- •History of gastric or duodenal ulcer
- •History of gastroparesis
- •History of abdominal radiation treatment
- •History of pancreatitis
- •History of intestinal stricture (e.g., Crohn's disease)
- •History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions
- •History of malabsorption
- •History of sucrose intolerance
- •History of hepatitis B or C
- •History of human immunodeficiency virus
- •History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
- •Any other clinically significant disease interfering with the assessments of Gelesis100, according to the Investigator (e.g., disease requiring corrective treatment, potentially leading to study discontinuation)
- •HbA1c > 8.5% (> 69 mmol/mol)
- •Positive test for drugs in the urine
- •Any relevant biochemical abnormality interfering with the assessments of Gelesis100, according to the Investigator
- •Antidiabetic medications within 1 month prior to Screening Visit (except stable dose of metformin, ≤ 1500 mg/day, for at least 1 month in subjects with type 2 diabetes)
- •Medications requiring mandatory administration with meal at lunch or dinner
- •Anticipated requirement for use of prohibited concomitant medications
- •Implanted or externally worn medical device such as, but not limited to, a pacemaker, infusion pump, or insulin pump
结局指标
主要结局
Change From Baseline in Colonic Transit Time (CTT)
时间窗: Up to 1 week; measured once during the run-in-period and again during third week of the treatment period
Colonic Transit Time is the amount of time (in minutes) that the SmartPill capsule spent in the large intestine before expulsion. We measured the difference between CTT pre-treatment and post-treatment and calculated the mean difference for each treatment group. Negative values equal a reduction in CTT.
次要结局
- Stool Consistency(55 days (baseline, treatment, & follow-up))
- Patient Assessment of Constipation Severity(55 days (baseline, treatment, & follow-up))
- Relief Rating(55 days (baseline, treatment, & follow-up))
- Complete Spontaneous Bowel Movement (CSBM) Frequency Rate(55 days (baseline, treatment, & follow-up))
- Patient's Assessment of Abdominal Discomfort(55 days (baseline, treatment, & follow-up))
- Patient Assessment of Constipation - Quality of Life (PAC-QOL)(Day -14 to Day 22)
- Ease of Passage Rating(55 days (baseline, treatment, & follow-up))
- Patient Assessment of Bloating Severity(55 days (baseline, treatment, & follow-up))
- Patient Assessment of Constipation - Symptoms (PAC-SYM)(Day -14 to Day 22)
- Need for Rescue Laxatives(55 days (baseline, treatment, & follow-up))
- Spontaneous Bowel Movement (SBM) Frequency(55 days (baseline, treatment, & follow-up))
研究者
Kyle Staller, MD, MPH
Kyle Staller, MD, MPH
Massachusetts General Hospital
研究点 (2)
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