Assessing GS500 in Functional Constipation

NCT04887896 | Unknown DMC

• 1 other identifier: GS-500-001
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Constipation - Functional

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

GS500 flexible dose

EXPERIMENTAL

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

Device: GS500

Placebo flexible dose

PLACEBO COMPARATOR

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

Device: Placebo

Interventions

GS500 DEVICE

Device: GS500

GS500 flexible dose

Placebo DEVICE

Device: Placebo

Placebo flexible dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gelesis, Inc.: lead

Central Study Contacts

Hassan M Heshmati, MD

CONTACT

(215) 275 - 1275; hheshmati@gelesis.com

Henry W Calderon, BS

CONTACT

(857) 201- 5330

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 14, 2021
• Study Start: July 15, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share