Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants (NCT NCT02510560)
NCT ID: NCT02510560
Last Updated: 2025-08-19
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
28 days or discharge from hospital
Results posted on
2025-08-19
Participant Flow
Participant milestones
| Measure |
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
|
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
|
Placebo
Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.
Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
108
|
94
|
98
|
|
Overall Study
COMPLETED
|
77
|
72
|
76
|
|
Overall Study
NOT COMPLETED
|
31
|
22
|
22
|
Reasons for withdrawal
| Measure |
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
|
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
|
Placebo
Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.
Placebo
|
|---|---|---|---|
|
Overall Study
Discontinued from Treatment
|
27
|
18
|
19
|
|
Overall Study
Other
|
4
|
4
|
3
|
Baseline Characteristics
Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
Baseline characteristics by cohort
| Measure |
NTRA-2112 A
n=108 Participants
NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.
NTRA-2112
|
NTRA-2112 B
n=94 Participants
NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.
NTRA-2112
|
Placebo
n=98 Participants
Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.
Placebo
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
26-28 weeks
|
49 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
146 Participants
n=483 Participants
|
|
Age, Customized
29-32 weeks
|
58 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
47 Participants
n=27 Participants
|
153 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
169 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
131 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
69 Participants
n=27 Participants
|
219 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
24 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
63 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
Netherlands
|
25 participants
n=93 Participants
|
24 participants
n=4 Participants
|
25 participants
n=27 Participants
|
74 participants
n=483 Participants
|
|
Region of Enrollment
Belgium
|
14 participants
n=93 Participants
|
5 participants
n=4 Participants
|
8 participants
n=27 Participants
|
27 participants
n=483 Participants
|
|
Region of Enrollment
Hungary
|
7 participants
n=93 Participants
|
6 participants
n=4 Participants
|
5 participants
n=27 Participants
|
18 participants
n=483 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
5 participants
n=4 Participants
|
5 participants
n=27 Participants
|
16 participants
n=483 Participants
|
|
Region of Enrollment
Italy
|
15 participants
n=93 Participants
|
13 participants
n=4 Participants
|
15 participants
n=27 Participants
|
43 participants
n=483 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=93 Participants
|
3 participants
n=4 Participants
|
5 participants
n=27 Participants
|
13 participants
n=483 Participants
|
|
Region of Enrollment
Israel
|
9 participants
n=93 Participants
|
6 participants
n=4 Participants
|
8 participants
n=27 Participants
|
23 participants
n=483 Participants
|
|
Region of Enrollment
France
|
4 participants
n=93 Participants
|
10 participants
n=4 Participants
|
12 participants
n=27 Participants
|
26 participants
n=483 Participants
|
|
Region of Enrollment
Germany
|
3 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
7 participants
n=483 Participants
|
|
Region of Enrollment
Spain
|
17 participants
n=93 Participants
|
19 participants
n=4 Participants
|
11 participants
n=27 Participants
|
47 participants
n=483 Participants
|
|
Region of Enrollment
Bulgaria
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
6 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 28 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.
Outcome measures
| Measure |
NTRA-2112 A
n=84 Participants
NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.
NTRA-2112
|
NTRA-2112 B
n=78 Participants
NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.
NTRA-2112
|
Placebo
n=76 Participants
Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.
Placebo
|
|---|---|---|---|
|
Numbers of Days to Achieve Complete Enteral Feeding
|
9.3 Days
Standard Deviation 4.81
|
10.0 Days
Standard Deviation 6.09
|
10.3 Days
Standard Deviation 5.10
|
SECONDARY outcome
Timeframe: 28 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)
Outcome measures
| Measure |
NTRA-2112 A
n=87 Participants
NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.
NTRA-2112
|
NTRA-2112 B
n=82 Participants
NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.
NTRA-2112
|
Placebo
n=85 Participants
Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.
Placebo
|
|---|---|---|---|
|
Number of Days to Achieve Discharge From Hospital or Readiness to Discharge
|
36.4 Days
Standard Deviation 16.26
|
33.8 Days
Standard Deviation 14.36
|
36 Days
Standard Deviation 15.21
|
Adverse Events
NTRA-2112 A
Serious events: 15 serious events
Other events: 91 other events
Deaths: 5 deaths
NTRA-2112 B
Serious events: 10 serious events
Other events: 70 other events
Deaths: 1 deaths
Placebo
Serious events: 19 serious events
Other events: 81 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
NTRA-2112 A
n=108 participants at risk
NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.
NTRA-2112
|
NTRA-2112 B
n=88 participants at risk
NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.
NTRA-2112
|
Placebo
n=97 participants at risk
Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.
Placebo
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
0.00%
0/108 • 18 months
|
0.00%
0/88 • 18 months
|
1.0%
1/97 • 18 months
|
|
Cardiac disorders
Atrial thrombosis
|
0.93%
1/108 • 18 months
|
0.00%
0/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.93%
1/108 • 18 months
|
0.00%
0/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.93%
1/108 • 18 months
|
3.4%
3/88 • 18 months
|
1.0%
1/97 • 18 months
|
|
Congenital, familial and genetic disorders
Cystic fibrosis
|
0.93%
1/108 • 18 months
|
0.00%
0/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
6.5%
7/108 • 18 months
|
3.4%
3/88 • 18 months
|
8.2%
8/97 • 18 months
|
|
Gastrointestinal disorders
Necrotising colitis
|
0.00%
0/108 • 18 months
|
1.1%
1/88 • 18 months
|
3.1%
3/97 • 18 months
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/108 • 18 months
|
0.00%
0/88 • 18 months
|
1.0%
1/97 • 18 months
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/108 • 18 months
|
0.00%
0/88 • 18 months
|
1.0%
1/97 • 18 months
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.00%
0/108 • 18 months
|
0.00%
0/88 • 18 months
|
1.0%
1/97 • 18 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.93%
1/108 • 18 months
|
0.00%
0/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/108 • 18 months
|
1.1%
1/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Gastrointestinal disorders
Neonatal gastrointestinal haemorrhage
|
0.93%
1/108 • 18 months
|
0.00%
0/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
General disorders
Injury associated with device
|
0.93%
1/108 • 18 months
|
0.00%
0/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/108 • 18 months
|
0.00%
0/88 • 18 months
|
1.0%
1/97 • 18 months
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.93%
1/108 • 18 months
|
0.00%
0/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Infections and infestations
Sepsis neonatal
|
3.7%
4/108 • 18 months
|
2.3%
2/88 • 18 months
|
5.2%
5/97 • 18 months
|
|
Infections and infestations
Neonatal pneumonia
|
0.00%
0/108 • 18 months
|
0.00%
0/88 • 18 months
|
2.1%
2/97 • 18 months
|
|
Infections and infestations
Meningitis neonatal
|
0.00%
0/108 • 18 months
|
0.00%
0/88 • 18 months
|
1.0%
1/97 • 18 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/108 • 18 months
|
0.00%
0/88 • 18 months
|
1.0%
1/97 • 18 months
|
|
Infections and infestations
Systemic candida
|
0.93%
1/108 • 18 months
|
0.00%
0/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Injury, poisoning and procedural complications
subarachnoid haemorrhage
|
0.93%
1/108 • 18 months
|
0.00%
0/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
0.00%
0/108 • 18 months
|
0.00%
0/88 • 18 months
|
1.0%
1/97 • 18 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/108 • 18 months
|
1.1%
1/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia neonatal
|
0.00%
0/108 • 18 months
|
1.1%
1/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Nervous system disorders
Intraventricular haemorrhage neonatal
|
0.00%
0/108 • 18 months
|
0.00%
0/88 • 18 months
|
1.0%
1/97 • 18 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/108 • 18 months
|
1.1%
1/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory acidosis
|
0.00%
0/108 • 18 months
|
1.1%
1/88 • 18 months
|
1.0%
1/97 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
0.93%
1/108 • 18 months
|
0.00%
0/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal aspiration
|
0.93%
1/108 • 18 months
|
0.00%
0/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
0.93%
1/108 • 18 months
|
0.00%
0/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.93%
1/108 • 18 months
|
0.00%
0/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.93%
1/108 • 18 months
|
0.00%
0/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Surgical and medical procedures
patent ductus arteriosus repair
|
0.93%
1/108 • 18 months
|
1.1%
1/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Vascular disorders
Hypertension neonatal
|
0.00%
0/108 • 18 months
|
0.00%
0/88 • 18 months
|
1.0%
1/97 • 18 months
|
|
Vascular disorders
Iliac vein occulsion
|
0.93%
1/108 • 18 months
|
0.00%
0/88 • 18 months
|
0.00%
0/97 • 18 months
|
|
Vascular disorders
Neonatal hypotension
|
0.00%
0/108 • 18 months
|
0.00%
0/88 • 18 months
|
1.0%
1/97 • 18 months
|
|
Vascular disorders
Shock haemorrhagic
|
0.93%
1/108 • 18 months
|
0.00%
0/88 • 18 months
|
0.00%
0/97 • 18 months
|
Other adverse events
| Measure |
NTRA-2112 A
n=108 participants at risk
NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital.
NTRA-2112
|
NTRA-2112 B
n=88 participants at risk
NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital.
NTRA-2112
|
Placebo
n=97 participants at risk
Placebo To be administered orally with daily feed for 28 days or until discharge from hospital.
Placebo
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
36.1%
39/108 • 18 months
|
38.6%
34/88 • 18 months
|
35.1%
34/97 • 18 months
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
18/108 • 18 months
|
15.9%
14/88 • 18 months
|
13.4%
13/97 • 18 months
|
|
Cardiac disorders
Bradycardia neonatal
|
5.6%
6/108 • 18 months
|
2.3%
2/88 • 18 months
|
3.1%
3/97 • 18 months
|
|
Cardiac disorders
Neonatal tachycardia
|
2.8%
3/108 • 18 months
|
5.7%
5/88 • 18 months
|
1.0%
1/97 • 18 months
|
|
Congenital, familial and genetic disorders
patent ductus arteriosis
|
11.1%
12/108 • 18 months
|
10.2%
9/88 • 18 months
|
9.3%
9/97 • 18 months
|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
6.5%
7/108 • 18 months
|
3.4%
3/88 • 18 months
|
8.2%
8/97 • 18 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.8%
3/108 • 18 months
|
5.7%
5/88 • 18 months
|
5.2%
5/97 • 18 months
|
|
Infections and infestations
Sepsis neonatal
|
8.3%
9/108 • 18 months
|
6.8%
6/88 • 18 months
|
8.2%
8/97 • 18 months
|
|
Infections and infestations
Ophthalmia neonatorum
|
3.7%
4/108 • 18 months
|
6.8%
6/88 • 18 months
|
10.3%
10/97 • 18 months
|
|
Metabolism and nutrition disorders
Neonatal hyponatraemia
|
11.1%
12/108 • 18 months
|
9.1%
8/88 • 18 months
|
8.2%
8/97 • 18 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.8%
3/108 • 18 months
|
2.3%
2/88 • 18 months
|
6.2%
6/97 • 18 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.9%
2/108 • 18 months
|
5.7%
5/88 • 18 months
|
3.1%
3/97 • 18 months
|
|
Nervous system disorders
Intraventricular haemorrhage neonatal
|
2.8%
3/108 • 18 months
|
5.7%
5/88 • 18 months
|
2.1%
2/97 • 18 months
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
3.7%
4/108 • 18 months
|
4.5%
4/88 • 18 months
|
5.2%
5/97 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Infantile apnoea
|
18.5%
20/108 • 18 months
|
13.6%
12/88 • 18 months
|
16.5%
16/97 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
8.3%
9/108 • 18 months
|
6.8%
6/88 • 18 months
|
2.1%
2/97 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
6.5%
7/108 • 18 months
|
3.4%
3/88 • 18 months
|
3.1%
3/97 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal hypoxia
|
3.7%
4/108 • 18 months
|
5.7%
5/88 • 18 months
|
0.00%
0/97 • 18 months
|
Additional Information
Miki Olshansky, Chief Executive Officer
Elgan Pharma Ltd.
Phone: 972-4-6098626
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place