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

Elgan Pharma

Status and phase: Terminated; Phase 3

Conditions: Premature Birth of Newborn; Intestinal Malabsorption

Treatments: Drug: Placebo; Drug: NTRA-2112

Study type: Interventional

Funder types: Industry

Identifiers

NCT02510560

FIT-04

Details and patient eligibility

About

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

Full description

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

Enrollment: 300 patients

Sex: All

Ages: 1 to 5 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound
2. Birth weight ≥ 500g
3. Singleton or twin birth

Exclusion Criteria

1. Complete enteral feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups, including a placebo group

NTRA-2112 A

Experimental group

Description:

NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.

Treatment:

Drug: NTRA-2112

NTRA-2112 B

Experimental group

Description:

NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.

Treatment:

Drug: NTRA-2112

Placebo

Placebo Comparator group

Description:

Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.

Treatment:

Drug: Placebo