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Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
Phase 3 trial testing NTRA-2112 in Premature Birth of Newborn in 300 participants. Terminated before completion.
| Lead sponsor | Elgan Pharma Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 9 October 2016 |
| Primary completion | 25 April 2018 |
| Estimated completion | 25 April 2018 |
| Sites | 50 locations across France, Italy, Netherlands, Belgium, United Kingdom, Germany, Hungary, Israel |
Elgan Pharma Ltd. — full company profile →
Adults 1 Day to 5 Days, any sex, with Premature Birth of Newborn or Intestinal Malabsorption. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| NTRA-2112 A | 9.3 | ± 4.81 |
| NTRA-2112 B | 10.0 | ± 6.09 |
| Placebo | 10.3 | ± 5.10 |
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)
| Group | Value | 95% CI |
|---|---|---|
| NTRA-2112 A | 36.4 | ± 16.26 |
| NTRA-2112 B | 33.8 | ± 14.36 |
| Placebo | 36 | ± 15.21 |
Time frame: 18 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | NTRA-2112 A | NTRA-2112 B | Placebo |
|---|---|---|---|---|
| Necrotising enterocolitis neonatal | Gastrointestinal disorders | — | — | — |
| Sepsis neonatal | Infections and infestations | — | — | — |
| Patent ductus arteriosus | Congenital, familial and genetic disorders | — | — | — |
| Necrotising colitis | Gastrointestinal disorders | — | — | — |
| Neonatal pneumonia | Infections and infestations | — | — | — |
| Anaemia neonatal | Blood and lymphatic system disorders | — | — | — |
| Atrial thrombosis | Cardiac disorders | — | — | — |
| Cardiopulmonary failure | Cardiac disorders | — | — | — |
| Cystic fibrosis | Congenital, familial and genetic disorders | — | — | — |
| Enterocolitis | Gastrointestinal disorders | — | — | — |
| Haematochezia | Gastrointestinal disorders | — | — | — |
| Ileal stenosis | Gastrointestinal disorders | — | — | — |
| Inguinal hernia | Gastrointestinal disorders | — | — | — |
| Intestinal perforation | Gastrointestinal disorders | — | — | — |
| Neonatal gastrointestinal haemorrhage | Gastrointestinal disorders | — | — | — |
| Injury associated with device | General disorders | — | — | — |
| Multiple organ dysfunction syndrome | General disorders | — | — | — |
| Portal vein thrombosis | Hepatobiliary disorders | — | — | — |
| Meningitis neonatal | Infections and infestations | — | — | — |
| Pneumonia | Infections and infestations | — | — | — |
| Systemic candida | Infections and infestations | — | — | — |
| subarachnoid haemorrhage | Injury, poisoning and procedural complications | — | — | — |
| hyperglycaemia | Metabolism and nutrition disorders | — | — | — |
| Hypoglycaemia | Metabolism and nutrition disorders | — | — | — |
| Hypoglycaemia neonatal | Metabolism and nutrition disorders | — | — | — |
| Reaction | System | NTRA-2112 A | NTRA-2112 B | Placebo |
|---|---|---|---|---|
| Anaemia neonatal | Blood and lymphatic system disorders | — | — | — |
| Infantile apnoea | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| patent ductus arteriosis | Congenital, familial and genetic disorders | — | — | — |
| Neonatal hyponatraemia | Metabolism and nutrition disorders | — | — | — |
| Ophthalmia neonatorum | Infections and infestations | — | — | — |
| Sepsis neonatal | Infections and infestations | — | — | — |
| Bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Necrotising enterocolitis neonatal | Gastrointestinal disorders | — | — | — |
| Neonatal respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Bradycardia neonatal | Cardiac disorders | — | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — | — |
| Neonatal tachycardia | Cardiac disorders | — | — | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — | — | — |
| Hypoglycaemia | Metabolism and nutrition disorders | — | — | — |
| Intraventricular haemorrhage neonatal | Nervous system disorders | — | — | — |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | — | — | — |
| Neonatal hypoxia | Respiratory, thoracic and mediastinal disorders | — | — | — |
Most-reported serious reactions: Necrotising enterocolitis neonatal, Sepsis neonatal, Patent ductus arteriosus, Necrotising colitis, Neonatal pneumonia, Anaemia neonatal, Atrial thrombosis, Cardiopulmonary failure.
Data from ClinicalTrials.gov NCT02510560 adverse events section.
The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02510560.
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