Assessing GS500 in Functional Constipation (TRANSIT)

Gelesis

Status: Unknown

Conditions: Constipation - Functional

Treatments: Device: Placebo; Device: GS500

Study type: Interventional

Funder types: Industry

Identifiers

NCT04887896

GS-500-001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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260 participants in 2 patient groups, including a placebo group

GS500 flexible dose

Experimental group

Description:

3, 2, or 4 GS500 capsules 2 times per day

Treatment:

Device: GS500

Placebo flexible dose

Placebo Comparator group

Description:

3, 2, or 4 placebo capsules 2 times per day

Treatment:

Device: Placebo