Trials / Completed
CompletedNCT03054506
The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation
A Randomized, Single Center, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Massachusetts General Hospital · Academic / Other
- Sex
- All
- Age
- 22 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-03-07
- Primary completion
- 2018-05-10
- Completion
- 2019-02-01
- First posted
- 2017-02-15
- Last updated
- 2019-08-20
- Results posted
- 2019-08-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03054506. Inclusion in this directory is not an endorsement.