Clincosm LogoSign in Get a demo

TRANSIT: Assessing GS500 in Functional Constipation

Sponsor
Gelesis, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04887896
Collaborator
(none)
260
Enrollment
2
Arms
17.5
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: GS500
  • Device: Placebo
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
260 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose.Multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of GS500 in Subjects With Functional Constipation
Anticipated Study Start Date :
Jul 15, 2022
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Primary Endpoint [8 weeks]

    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

  1. Straining score (EoPS) [8 weeks]

  2. Constipation severity (self-assessment on 0 to 10 numerical rating scale) [8 weeks]

  3. SBM stool consistency (BSFS) [8 weeks]

  4. SBM frequency rate (SBMs/week) [8 weeks]

  5. CSBM frequency rate (CSBMs/week) [8 weeks]

  6. Proportion of subjects with increase of ≥2 CSBMduringat least6 of the 8 weeks of the Effectiveness period [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Gelesis, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gelesis, Inc.
ClinicalTrials.gov Identifier:
NCT04887896
Other Study ID Numbers:
  • GS-500-001
First Posted:
May 14, 2021
Last Update Posted:
Jan 24, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Constipation

Study Results

No Results Posted as of Jan 24, 2022