Assessing GS500 in Functional Constipation

Study Overview
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Brief Summary
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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
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To evaluate the safety, tolerabilityand efficacy of GS500 as a superabsorbent hydrogel for relief of constipation in subjects with functional constipation.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of GS500 in Subjects With Functional Constipation

Conditions
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Constipation - Functional

Intervention / Treatment
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* Device: GS500
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GS500 flexible dose<br>3, 2, or 4 GS500 capsules 2 times per day | Device: GS500<br>* Device: GS500<br>|
| Placebo Comparator: Placebo flexible dose<br>3, 2, or 4 placebo capsules 2 times per day | Device: Placebo<br>* Device: Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint | 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 | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |