NCT04887896Unknown不适用
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of GS500 in Subjects With Functional Constipation
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 260
- 主要终点
- Primary Endpoint
研究概览
简要总结
This study is designed to evaluate the safety, tolerability and efficacy of GS500 as a superabsorbent hydrogel for relief of constipation in subjects with functional constipation.
详细描述
To evaluate the safety, tolerabilityand efficacy of GS500 as a superabsorbent hydrogel for relief of constipation in subjects with functional constipation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤75 years old
- •BMI ≥18.5 and <35 kg/m2
- •Rome IV criteria for FC
- •Compliant with reporting during Baseline Run-in .
- •Ability to record daily bowel habits, including frequency, stool consistency, straining, completeness of evacuation, and patient reported outcomes
- •Ability to follow verbal and written instructions
- •Consent obtained via signed ICF
排除标准
- •Meeting Rome IV criteria for IBSat screening
- •Missing > 2 days of daily bowel habits reporting during either week of the Baseline Run-in period
- •Patients reporting laxative, enema, and/or suppository usage for >2 days or any usage of a prohibited medication during the Baseline Run-in
- •Patients reporting watery stools for any SBM or loose stools for >1 SBM in the absence of laxatives during Baseline Run-in
- •Need for routine manual maneuvers in the last 6 months in order to achieve a BM
- •History of significant GI lumen surgery at any time or other GI or abdominal surgery except cholecystectomy or appendectomy within 2 months prior to screening
- •Documented GI obstruction
- •History of laxative abuseas judged by investigator team
- •Glycosylated hemoglobin (HbA1c) ≥8.5%
- •Known history of Crohn's disease or ulcerative colitis
- •Pregnancy in females of childbearing potential or lactation
- •Absence of medically approved contraception in females of childbearing potential
- •History of allergic reaction to carboxymethylcellulose, citric acid, sodium stearyl fumarate, HPMC, pectin, gelatin, maltotextrin or titanium dioxide
- •Currently enrolled in another investigational device or drug study, or less than 3 months since ending another investigational device or drug study(s), or receiving other investigational treatment(s).
- •Subjects anticipating surgical intervention during the study
- •Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
- •History of swallowing disorders
- •History of gastroparesis
- •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 maltodextrin intolerance
- •Presence of metastatic cancer or current use of systemic anti-cancer treatments
- •Anticipated requirement for use of prohibited concomitant medications
- •Current use of prescribed or illicit opioids
- •Use of intestinal secretagogues to treat constipation/IBS within 12 months of the screening visit
- •Any other clinically significant disease or biochemical abnormality interfering with the assessments of GS500, according to the Investigator
结局指标
主要结局
Primary Endpoint
时间窗: 8 weeks
Proportion of CSBM Responders defined as subjects with increase of ≥ 1 CSBM from Baseline Run-In during at least 6 of the 8 weeks of the Effectiveness period
次要结局
- Constipation severity (self-assessment on 0 to 10 numerical rating scale)(8 weeks)
- CSBM frequency rate (CSBMs/week)(8 weeks)
- Proportion of subjects with increase of ≥2 CSBMduringat least6 of the 8 weeks of the Effectiveness period(8 weeks)
- SBM frequency rate (SBMs/week)(8 weeks)
- Straining score (EoPS)(8 weeks)
- SBM stool consistency (BSFS)(8 weeks)
研究者
相似试验
撤回
1 期
GS-441524 for COVID-19 SAD, FE, and MAD Study in Healthy SubjectsCOVID-19NCT06274853National Center for Advancing Translational Sciences (NCATS)70
已完成
1 期
Safety Study of GSK1995057 Given as Single and Repeat Intravenous Doses in Healthy Subjects.Respiratory DisordersNCT01476046GlaxoSmithKline56
已完成
1 期
Single Dose Escalation Trial to Evaluate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics of GSK3050002Colitis, UlcerativeNCT01984047GlaxoSmithKline49
已完成
1 期
Phase 1b Safety, Tolerability, and PK Study to Assess GS-5737 in Subjects With CFCystic FibrosisNCT01840735Gilead Sciences8
撤回
1 期
Safety Study of GS-5806 to Treat Respiratory Syncytial Virus (RSV)Respiratory Syncytial Virus InfectionsNCT01797419Gilead Sciences