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

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ClinicalTrials.gov Identifier: NCT04887896
Recruitment Status : Not yet recruiting
First Posted : May 14, 2021
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Gelesis, Inc.

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
Constipation - Functional Device: GS500 Device: Placebo Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Estimated Study Start Date : July 15, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

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




Primary Outcome Measures :
  1. Primary Endpoint [ Time Frame: 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) [ Time Frame: 8 weeks ]
  2. Constipation severity (self-assessment on 0 to 10 numerical rating scale) [ Time Frame: 8 weeks ]
  3. SBM stool consistency (BSFS) [ Time Frame: 8 weeks ]
  4. SBM frequency rate (SBMs/week) [ Time Frame: 8 weeks ]
  5. CSBM frequency rate (CSBMs/week) [ Time Frame: 8 weeks ]
  6. Proportion of subjects with increase of ≥2 CSBMduringat least6 of the 8 weeks of the Effectiveness period [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04887896


Contacts
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Contact: Hassan M Heshmati, MD (215) 275 - 1275 hheshmati@gelesis.com
Contact: Henry W Calderon, BS (857) 201- 5330 hcalderon@gelesis.com

Sponsors and Collaborators
Gelesis, Inc.
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Responsible Party: Gelesis, Inc.
ClinicalTrials.gov Identifier: NCT04887896    
Other Study ID Numbers: GS-500-001
First Posted: May 14, 2021    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive