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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 is a Phase 2 study that was terminated before completion, run by Forest Laboratories. The registered enrollment target is 101 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02559817
The ClinicalTrials.gov registry entry for NCT02559817 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Matching Placebo is the first listed.
NCT02559817 reports 0 study locations.
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.
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