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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: Completed Phase 2 study of Colic, sponsored by Menarini Group.
NCT01532518 is a Phase 2 study of Colic that has completed, run by Menarini Group. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Results obtained at V2 serve as baseline values for the assessment of effects at V3 (i.e. end of first week of treatment). Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R ), with a minimum-maximum score of 0-42 (minimum for diagnosis \>15). The higher values reflect worse outcome. The questionnaire comprised 12 items as questions quantifying aspects of regurgitation (3 questions), crying (3 questions), feeding refusal (2 questions), apnea/cyanosis (2 questions), hiccups and archi
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 |
What the finished NCT01532518 record still lists
NCT01532518 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
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 lists 5 locations in 5 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01532518's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 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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