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NCT01532518 · ClinicalTrials.gov registry record · Phase 2
Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance
A Phase 2 study of Colic, sponsored by Menarini Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 5
- Study locations
NCT01532518 is a Phase 2 study of Colic that has completed, run by Menarini Group. The registered enrollment target is 27 participants. The trial reports 5 study locations across 5 states.
The verdict
NCT01532518, a Phase 2 study of Colic, has completed, sponsored by Menarini Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 5
- Study locations
Study Summary
The present pilot study is aimed to obtain preliminary data on the effect of three ascending oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance. In addition, the assessment of drug exposure (PK assessment) will provide additional information on the dose-effect relationship, thus supporting the dose selection and dosing schedule in the future studies.
Conditions Studied
Interventions
- DRUG Nepadutant
Study Locations (5)
Arkansas
- Arkansas Children's Hospital - Little Rock
Georgia
- Children's Center for Digestive Healthcare - Atlanta
Kentucky
- Kosair Charities Pediatric Clinical Research Unit / University of Louisville - Louisville
New York
- SUNY Downstate Medical Center - Albany
Ohio
- The University of Toledo College of Medicine\The Toledo Children's Hospital - Toledo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01532518
The ClinicalTrials.gov registry entry for NCT01532518 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Menarini Group, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Colic appearing as the primary indexed condition, and to 1 intervention - of which Nepadutant is the first listed.
NCT01532518 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Arkansas, Georgia, Kentucky.
Frequently Asked Questions
What is clinical trial NCT01532518 about?
NCT01532518 is a clinical study titled "Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance". The present pilot study is aimed to obtain preliminary data on the effect of three ascending oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance. In addition, the assessment of drug exposure (PK assessment) will provide additional information on the dose-effe...
What is the current status of trial NCT01532518?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2011-08. Estimated completion is 2012-07.
What conditions does trial NCT01532518 study?
This clinical trial studies the following conditions: Colic.
What interventions are being tested in trial NCT01532518?
The interventions under investigation include: Nepadutant (DRUG).
Who is sponsoring clinical trial NCT01532518?
This trial is sponsored by Menarini Group, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01532518 being conducted?
This trial has 5 study locations across Arkansas, Georgia, Kentucky, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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