Assessing GS500 in Functional Constipation

NCT ID: NCT04887896

Last Updated: 2022-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2023-12-30

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.

Conditions

Constipation - Functional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GS500 flexible dose

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

Group Type: EXPERIMENTAL

GS500

Intervention Type: DEVICE

Device: GS500

Placebo flexible dose

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

Device: Placebo

Interventions

GS500

Device: GS500

Intervention Type: DEVICE

Placebo

Device: Placebo

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gelesis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Hassan M Heshmati, MD

Role: CONTACT

hheshmati@gelesis.com

(215) 275 - 1275

Henry W Calderon, BS

Role: CONTACT

(857) 201- 5330

Other Identifiers

GS-500-001

Identifier Type: -

Identifier Source: org_study_id