Status:
UNKNOWN
Assessing GS500 in Functional Constipation
Lead Sponsor:
Gelesis, Inc.
Conditions:
Constipation - Functional
Eligibility:
All Genders
18-75 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04887896
Start Date
July 15 2022
End Date
December 30 2023
Last Update
January 24 2022
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