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NCT02559817 · ClinicalTrials.gov registry record · Phase 2
A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation
A Phase 2 study, sponsored by Forest Laboratories.
- Terminated
- Registry status
- Phase 2
- Development phase
- 101
- Enrollment target
NCT02559817: Clinical Trial Phase 2 study, sponsored by Forest Laboratories.
NCT02559817 is a Phase 2 study that was terminated before completion, run by Forest Laboratories. The registered enrollment target is 101 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02559817, a Phase 2 study, was terminated before completion, sponsored by Forest Laboratories.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks. This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of IBS-C.
Primary Outcome
SBM was defined as a 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. SBM rate was defined as SBMs/week during the 4-week Treatment period. Participants recorded the occurrence of BMs and use of rescue medication, morning and evening, daily in an eDiary since pretreatment period. The SBM frequency rate (SBMs/week) during the analysis period for each participant were calculated as \[(total number of SBMs in the
Interventions
- DRUG Matching Placebo
- DRUG Linaclotide Dose A
- DRUG Linaclotide Dose B
- DRUG Linaclotide Dose C
- DRUG Linaclotide Approved Adult Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2015-11-01 |
| Est. Completion | 2019-08-30 |
| Phase | Phase 2 |
Why NCT02559817 stopped before completion
NCT02559817 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 5 interventions - of which Matching Placebo is the first listed.
NCT02559817 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02559817 about?
NCT02559817 is a clinical study titled "A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation". The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 7-11 will rec...
What is the current status of trial NCT02559817?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2015-11-01. Estimated completion is 2019-08-30.
What interventions are being tested in trial NCT02559817?
The interventions under investigation include: Matching Placebo (DRUG), Linaclotide Dose A (DRUG), Linaclotide Dose B (DRUG), Linaclotide Dose C (DRUG), Linaclotide Approved Adult Dose (DRUG).
Who is sponsoring clinical trial NCT02559817?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02559817's enrollment target sits among peer trials
101 672nd of 2000 higher than 1,329 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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