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NCT02559570 · ClinicalTrials.gov registry record · Phase 2
A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)
A Phase 2 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 2
- Development phase
- 173
- Enrollment target
NCT02559570 is a Phase 2 study that has completed, run by Forest Laboratories. The registered enrollment target is 173 participants.
The verdict
NCT02559570, a Phase 2 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 173 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate dose response of the safety and efficacy of linaclotide for the treatment of functional constipation (FC), in children age 6-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Participants age 6-11 years will receive oral liquid formulation and participants 12-17 years will receive solid oral capsule or liquid oral solution. Children ages 6-11 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 FC.
Interventions
- DRUG Placebo
- DRUG LIN Dose A
- DRUG LIN Dose B
- DRUG LIN Dose C
- DRUG LIN 145 µg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2015-11-03 |
| Est. Completion | 2018-05-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02559570
The ClinicalTrials.gov registry entry for NCT02559570 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 173 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 Placebo is the first listed.
NCT02559570 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02559570 about?
NCT02559570 is a clinical study titled "A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)". The purpose of this study was to evaluate dose response of the safety and efficacy of linaclotide for the treatment of functional constipation (FC), in children age 6-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Participants age 6-11 years wil...
What is the current status of trial NCT02559570?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 173 participants. The study started on 2015-11-03. Estimated completion is 2018-05-29.
What interventions are being tested in trial NCT02559570?
The interventions under investigation include: Placebo (DRUG), LIN Dose A (DRUG), LIN Dose B (DRUG), LIN Dose C (DRUG), LIN 145 µg (DRUG).
Who is sponsoring clinical trial NCT02559570?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
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