Constipation - Functional
Conditions
Brief summary
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.
Detailed description
To evaluate the safety, tolerabilityand efficacy of GS500 as a superabsorbent hydrogel for relief of constipation in subjects with functional constipation.
Interventions
DEVICEGS500
Device: GS500
DEVICEPlacebo
Device: Placebo
Sponsors
Gelesis, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Straining score (EoPS) | 8 weeks |
| Constipation severity (self-assessment on 0 to 10 numerical rating scale) | 8 weeks |
| SBM stool consistency (BSFS) | 8 weeks |
| SBM frequency rate (SBMs/week) | 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 |
Contacts
Primary ContactHassan M Heshmati, MD
Backup ContactHenry W Calderon, BS
Outcome results
None listed