FindTrial
Sign In

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

A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02510560
Enrollment
300
Registered
2015-07-29
Start date
2016-10-09
Completion date
2018-04-25
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Malabsorption, Premature Birth of Newborn

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

Interventions

DRUGNTRA-2112
DRUGPlacebo

Sponsors

Elgan Pharma Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Days to 5 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Numbers of Days to Achieve Complete Enteral Feeding28 days or discharge from hospitalNumbers 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

MeasureTime frameDescription
Number of Days to Achieve Discharge From Hospital or Readiness to Discharge28 days or discharge from hospitalReadiness 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)

Countries

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

Participant flow

Participants by arm

ArmCount
NTRA-2112 A
NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital. NTRA-2112
108
NTRA-2112 B
NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital. NTRA-2112
94
Placebo
Placebo To be administered orally with daily feed for 28 days or until discharge from hospital. Placebo
98
Total300

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDiscontinued from Treatment271819
Overall StudyOther443

Baseline characteristics

CharacteristicNTRA-2112 ANTRA-2112 BPlaceboTotal
Age, Customized
26-28 weeks
49 Participants46 Participants51 Participants146 Participants
Age, Customized
29-32 weeks
58 Participants48 Participants47 Participants153 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
6 Participants5 Participants6 Participants17 Participants
Race (NIH/OMB)
More than one race
24 Participants17 Participants22 Participants63 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
78 Participants72 Participants69 Participants219 Participants
Region of Enrollment
Belgium
14 participants5 participants8 participants27 participants
Region of Enrollment
Bulgaria
3 participants1 participants2 participants6 participants
Region of Enrollment
France
4 participants10 participants12 participants26 participants
Region of Enrollment
Germany
3 participants2 participants2 participants7 participants
Region of Enrollment
Hungary
7 participants6 participants5 participants18 participants
Region of Enrollment
Israel
9 participants6 participants8 participants23 participants
Region of Enrollment
Italy
15 participants13 participants15 participants43 participants
Region of Enrollment
Netherlands
25 participants24 participants25 participants74 participants
Region of Enrollment
Spain
17 participants19 participants11 participants47 participants
Region of Enrollment
United Kingdom
5 participants3 participants5 participants13 participants
Region of Enrollment
United States
6 participants5 participants5 participants16 participants
Sex: Female, Male
Female
64 Participants51 Participants54 Participants169 Participants
Sex: Female, Male
Male
44 Participants43 Participants44 Participants131 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
5 / 1081 / 884 / 97
other
Total, other adverse events
91 / 10870 / 8881 / 97
serious
Total, serious adverse events
15 / 10810 / 8819 / 97

Outcome results

Primary

Numbers of Days to Achieve Complete Enteral Feeding

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.

Time frame: 28 days or discharge from hospital

ArmMeasureValue (MEAN)Dispersion
NTRA-2112 ANumbers of Days to Achieve Complete Enteral Feeding9.3 DaysStandard Deviation 4.81
NTRA-2112 BNumbers of Days to Achieve Complete Enteral Feeding10.0 DaysStandard Deviation 6.09
PlaceboNumbers of Days to Achieve Complete Enteral Feeding10.3 DaysStandard Deviation 5.1
p-value: 0.115Stratified Van Elteren Test
p-value: 0.243Stratified Van Elteren Test
Secondary

Number of Days to Achieve Discharge From Hospital or Readiness to Discharge

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)

Time frame: 28 days or discharge from hospital

ArmMeasureValue (MEAN)Dispersion
NTRA-2112 ANumber of Days to Achieve Discharge From Hospital or Readiness to Discharge36.4 DaysStandard Deviation 16.26
NTRA-2112 BNumber of Days to Achieve Discharge From Hospital or Readiness to Discharge33.8 DaysStandard Deviation 14.36
PlaceboNumber of Days to Achieve Discharge From Hospital or Readiness to Discharge36 DaysStandard Deviation 15.21
p-value: 0.714Stratified Van Elteren Test
p-value: 0.243Stratified Van Elteren Test

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026