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NCT03054506 · ClinicalTrials.gov registry record · NA
The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
NCT03054506: Completed NA study, sponsored by Massachusetts General Hospital.
NCT03054506 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 52 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03054506, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
Study 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).
Primary Outcome
Colonic Transit Time is the amount of time (in minutes) that the SmartPill capsule spent in the large intestine before expulsion. We measured the difference between CTT pre-treatment and post-treatment and calculated the mean difference for each treatment group. Negative values equal a reduction in CTT.
Interventions
- DEVICE Placebo
- DEVICE CSP01
- DEVICE Carboxymethylcellulose (CMC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2017-03-07 |
| Est. Completion | 2019-02-01 |
| Phase | NA |
What the finished NCT03054506 record still lists
NCT03054506 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03054506 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03054506 about?
NCT03054506 is a clinical study titled "The Effect of CSP01 on Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation". 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 ...
What is the current status of trial NCT03054506?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2017-03-07. Estimated completion is 2019-02-01.
What interventions are being tested in trial NCT03054506?
The interventions under investigation include: Placebo (DEVICE), CSP01 (DEVICE), Carboxymethylcellulose (CMC) (DEVICE).
Who is sponsoring clinical trial NCT03054506?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03054506's enrollment target sits among peer trials
52 1272nd of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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