Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants

NCT02510560 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-08-19

Study results available
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Summary

The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.

Conditions

  • Premature Birth of Newborn
  • Intestinal Malabsorption

Interventions

DRUG

NTRA-2112

DRUG

Placebo

Sponsors & Collaborators

  • Elgan Pharma Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
5 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-09
Primary Completion
2018-04-25
Completion
2018-04-25

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02510560 on ClinicalTrials.gov