Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants

Phase 3

Not yet recruiting

• Conditions: Intestinal Malabsorption
• Interventions: Drug: Placebo; Drug: ELGN-2112

• Registration Number: NCT05670951
• Lead Sponsor: Elgan Pharma Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-02
• Study First Submitted QC: 2023-01-02
• Study First Posted: 2023-01-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04
• Study Start: 2023-11
• Primary Completion: 2025-11
• Study Completion: 2031-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• 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
• Birth weight ≥ 500g
• Singleton or twin birth

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
ELGN-2112	ELGN-2112	-

Primary Outcome Measures

Name	Time	Method
Numbers of days to achieve full enteral feeding	28 days or discharge from hospital