Assessing GS500 in Functional Constipation

Constipation - Functional Clinical Trial

— TRANSIT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04887896
• Other study ID #: GS-500-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2022
• Source: Gelesis, Inc.
• Contact: Hassan M Heshmati, MD
• Phone: (215) 275 - 1275
• Email: hheshmati[@]gelesis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional

Intervention

Device:
• GS500
Device: GS500
• Placebo
Device: Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gelesis, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Straining score (EoPS)		8 weeks
Secondary	Constipation severity (self-assessment on 0 to 10 numerical rating scale)		8 weeks
Secondary	SBM stool consistency (BSFS)		8 weeks
Secondary	SBM frequency rate (SBMs/week)		8 weeks
Secondary	CSBM frequency rate (CSBMs/week)		8 weeks
Secondary	Proportion of subjects with increase of =2 CSBMduringat least6 of the 8 weeks of the Effectiveness period		8 weeks