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NCT04110145 · ClinicalTrials.gov registry record · Phase 2
Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation
A Phase 2 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT04110145: Completed Phase 2 study, sponsored by Allergan.
NCT04110145 is a Phase 2 study that has completed, run by Allergan. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04110145, a Phase 2 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the dose response, safety, and efficacy of linaclotide when compared with placebo in pediatric participants, 2 to 5 years of age, with Functional Constipation.
Primary Outcome
A SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, suppository, or enema use on the calendar day of the BM or the calendar day before the BM. Each day the caregiver recorded the number of SBMs in the last 24 hours in an electronic diary (eDiary). The SBM frequency rate (SBMs/week) during the analysis period for each participant was calculated as \[(total number of SBMs in the analysis period/number of days in the analysis period)\*7\]. Baseline value was based o
Interventions
- DRUG Placebo
- DRUG Linaclotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2019-10-14 |
| Est. Completion | 2021-04-20 |
| Phase | Phase 2 |
What the finished NCT04110145 record still lists
NCT04110145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04110145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04110145 about?
NCT04110145 is a clinical study titled "Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation". The purpose of this study is to evaluate the dose response, safety, and efficacy of linaclotide when compared with placebo in pediatric participants, 2 to 5 years of age, with Functional Constipation.
What is the current status of trial NCT04110145?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2019-10-14. Estimated completion is 2021-04-20.
What interventions are being tested in trial NCT04110145?
The interventions under investigation include: Placebo (DRUG), Linaclotide (DRUG).
Who is sponsoring clinical trial NCT04110145?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04110145's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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