Clinical trial NCT04887896: Assessing GS500 in Functional Constipation
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of GS500 in Subjects With Functional Constipation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation - Functional
Lead sponsor: Gelesis, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-14
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Primary Endpoint
timeFrame: 8 weeks
Secondary outcomes:
measure: Straining score (EoPS)
timeFrame: 8 weeks
measure: Constipation severity (self-assessment on 0 to 10 numerical rating scale)
timeFrame: 8 weeks
measure: SBM stool consistency (BSFS)
timeFrame: 8 weeks
measure: SBM frequency rate (SBMs/week)
timeFrame: 8 weeks
measure: CSBM frequency rate (CSBMs/week)
timeFrame: 8 weeks
measure: Proportion of subjects with increase of ≥2 CSBMduringat least6 of the 8 weeks of the Effectiveness period
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References: