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Assessing GS500 in Functional Constipation (TRANSIT)

Primary Purpose

Constipation - Functional

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

GS500

Placebo

About this trial

This is an interventional treatment trial for Constipation - Functional

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GS500 flexible dose

Placebo flexible dose

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Straining score (EoPS)

Constipation severity (self-assessment on 0 to 10 numerical rating scale)

SBM stool consistency (BSFS)

SBM frequency rate (SBMs/week)

CSBM frequency rate (CSBMs/week)

Proportion of subjects with increase of ≥2 CSBMduringat least6 of the 8 weeks of the Effectiveness period

Full Information

NCT ID

NCT04887896

First Posted

May 11, 2021

Last Updated

January 21, 2022

Sponsor

Gelesis, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04887896

Brief Title

Assessing GS500 in Functional Constipation

Acronym

TRANSIT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 15, 2022 (Anticipated)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gelesis, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation - Functional

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GS500 flexible dose

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo flexible dose

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

GS500

Intervention Description

Device: GS500

Intervention Type

Device

Intervention Name(s)

Placebo

Intervention Description

Device: Placebo

Primary Outcome Measure Information:

Title

Primary Endpoint

Description

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

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Straining score (EoPS)

Time Frame

8 weeks

Title

Constipation severity (self-assessment on 0 to 10 numerical rating scale)

Time Frame

8 weeks

Title

SBM stool consistency (BSFS)

Time Frame

8 weeks

Title

SBM frequency rate (SBMs/week)

Time Frame

8 weeks

Title

CSBM frequency rate (CSBMs/week)

Time Frame

8 weeks

Title

Proportion of subjects with increase of ≥2 CSBMduringat least6 of the 8 weeks of the Effectiveness period

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hassan M Heshmati, MD

Phone

(215) 275 - 1275

hheshmati@gelesis.com

First Name & Middle Initial & Last Name or Official Title & Degree

Henry W Calderon, BS

Phone

(857) 201- 5330

12. IPD Sharing Statement

Plan to Share IPD

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Assessing GS500 in Functional Constipation

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