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

Phase 3

Terminated

• Conditions: Premature Birth of Newborn; Intestinal Malabsorption
• Interventions: Drug: NTRA-2112; Drug: Placebo

• Registration Number: NCT02510560
• Lead Sponsor: Elgan Pharma Ltd.

Brief Summary

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

Detailed Description

The study will assess the efficacy and safety of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo

Study Timeline

• Study First Submitted: 2015-07-24
• Study First Submitted QC: 2015-07-26
• Study First Posted: 2015-07-29
• Study Start: 2016-10-09
• Primary Completion: 2018-04-25
• Study Completion: 2018-04-25
• Results First Submitted: 2025-05-22
• Results First Submitted QC: 2025-05-22
• Results First Posted: 2025-06-06
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-31
• Last Update Posted: 2025-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NTRA-2112 A	NTRA-2112	NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.
Placebo	Placebo	Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.
NTRA-2112 B	NTRA-2112	NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.

Primary Outcome Measures

Name	Time	Method
Numbers of Days to Achieve Complete Enteral Feeding	28 days or discharge from hospital	Numbers of days to achieve full enteral feeding (NFE) is defined as: Number of Days to the first day of achieving enteral feeding of at least 150 ml/kg/day, which must be sustained for at least 3 consecutive days.

Secondary Outcome Measures

Name	Time	Method
Number of Days to Achieve Discharge From Hospital or Readiness to Discharge	28 days or discharge from hospital	Readiness for discharge from hospital is defined as achieving all of the below: * Infant weight ≥ 1800g; * Stable body temperature; * Capable of oral feeding (reached full enteral feeding and not dependent on PN)

Trial Locations

Locations (50)

Vidant Medical Center; 🇺🇸 Greenville, North Carolina, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

AZ Sint-Jan; 🇧🇪 Brugge, Belgium

UZ Brussel; 🇧🇪 Brussel, Belgium

CHR de la Citadelle; 🇧🇪 Liege, Belgium

CHC Cliniques Saint-Vincent; 🇧🇪 Rocourt, Belgium

GZA Sint-Augustinus; 🇧🇪 Wilrijk, Belgium

CHRU Nancy, Maternité Régionale; 🇫🇷 Nancy, France

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