Assessing GS500 in Functional Constipation (TRANSIT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Constipation - Functional
• Intervention / Treatment: Device: GS500; Device: Placebo

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hassan M Heshmati, MD; Phone Number: (215) 275 - 1275; Email: hheshmati@gelesis.com
• Study Contact Backup: Name: Henry W Calderon, BS; Phone Number: (857) 201- 5330

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GS500 flexible dose; 3, 2, or 4 GS500 capsules 2 times per day	Device: GS500; Device: GS500
Placebo Comparator: Placebo flexible dose; 3, 2, or 4 placebo capsules 2 times per day	Device: Placebo; Device: Placebo

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Gelesis, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: GS-500-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No