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The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation

NCT03054506 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2019-08-20

Study results available
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Summary

Constipation is a common gastrointestinal motility disorder that is often chronic, negatively affects patients' daily lives. Constipation occurs when bowel movements become difficult or less frequent.This study is being done to study the effectiveness of the hydrogel capsule, CSP01, compared to the active control (carboxymethylcellulose) and placebo (non-medicine sugar pill), to relieve constipation among subjects with chronic idiopathic constipation (CIC) or with irritable bowel syndrome with constipation (IBS-C).

Conditions

  • Constipation
  • Chronic Idiopathic Constipation
  • Irritable Bowel Syndrome With Constipation

Interventions

DEVICE

CSP01

Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.

DEVICE

Carboxymethylcellulose (CMC)

Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.

DEVICE

Placebo

Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.

Sponsors & Collaborators

  • Gelesis, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Kyle Staller, MD, MPH · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-07
Primary Completion
2018-05-10
Completion
2019-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03054506 on ClinicalTrials.gov