Assessing GS500 in Functional Constipation

Not Applicable

• Conditions: Constipation - Functional
• Interventions: Device: Placebo; Device: GS500

• Registration Number: NCT04887896
• Lead Sponsor: Gelesis, Inc.

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.

Study Timeline

• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-14
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-01-24
• Study Start: 2022-07-15
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo flexible dose	Placebo	3, 2, or 4 placebo capsules 2 times per day
GS500 flexible dose	GS500	3, 2, or 4 GS500 capsules 2 times per day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Straining score (EoPS)	8 weeks
SBM stool consistency (BSFS)	8 weeks
Constipation severity (self-assessment on 0 to 10 numerical rating scale)	8 weeks