Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
NCT ID: NCT02510560
Last Updated: 2025-08-19
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
300 participants
INTERVENTIONAL
2016-10-09
2018-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Interventions
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NTRA-2112
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Birth weight ≥ 500g
3. Singleton or twin birth
Exclusion Criteria
1 Day
5 Days
ALL
No
Sponsors
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Elgan Pharma Ltd.
INDUSTRY
Responsible Party
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Locations
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Vidant Medical Center
Greenville, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
AZ Sint-Jan
Bruges, , Belgium
UZ Brussel
Brussels, , Belgium
CHR de la Citadelle
Liège, , Belgium
CHC Cliniques Saint-Vincent
Rocourt, , Belgium
GZA Sint-Augustinus
Wilrijk, , Belgium
CHRU Nancy, Maternité Régionale
Nancy, , France
CHU Necker-Enfants Malades
Paris, , France
CHU - Hôpital Sud
Rennes, , France
Kinderklinik, Evangelisches Waldkrankenhaus Spandau
Berlin, , Germany
Klinik und Poliklinik fur Kinder-und Jugendmedizin, Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Klinik fur Neugeborene, Kinder und Jugendliche, Universitatsklinik der Paracelsus Medizinischen Privatuniversitat
Nuremberg, , Germany
Klinik fuer Kinder und Jugendliche, Helios Klinikum Pforzheim
Pforzheim, , Germany
Kinderklinik, Evangelisches Waldkrankenhaus
Spandau, , Germany
DE KK Gyermekklinika
Debrecen, , Hungary
Szegedi Tudomanyegyetem Szent Gyorgyi Albert Klinikai Kozpont Gyermekgyogyaszati klinika Koraszulott Intenzív Osztaly
Szeged, , Hungary
Fejéktató Kórhz Újszülött, Csecsemő és Gyermekosztály - Megyei Szent György Egyetemi
Székesfehérvár, , Hungary
Csolnoky Ferenc Korhaz
Veszprém, , Hungary
Barzilai MC
Ashkelon, , Israel
Soroka Medical Center
Beersheba, , Israel
Bnai Zion MC
Haifa, , Israel
Rambam Health Care Campus
Haifa, , Israel
Laniado
Netanya, , Israel
Schneider Children's Medical Center
Petah Tikva, , Israel
Sheba MC
Ramat Gan, , Israel
Tel Aviv Sourasky MC
Tel Aviv, , Israel
Presidio Ospedaliero G. Salesi - AOUI Ospedali Riuniti di Ancona
Ancona, , Italy
Granda Ospedale Maggiore Policlinico
Milan, , Italy
Ospedale dei Bambini "V.Buzzi"- Azienda ICP
Milan, , Italy
Azienda Ospedaliera San Gerardo
Monza, , Italy
Policlinico Gemelli
Rome, , Italy
Azienda Ospedaliero Universitaria
Udine, , Italy
Ospedale F. Del Ponte - Azienda Ospedaliera di Varese
Varese, , Italy
AMC - Academic Medical Center
Amsterdam, , Netherlands
UMC Groningen (UMCG), Beatrix Kinderziekenhuis
Groningen, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Vall d'Hebron
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
La-Paz
Madrid, , Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, , Spain
CHUS - Complejo Hospitalario Universitario de Santiago
Santiago, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Bradford Royal Infirmary
Bradford, , United Kingdom
University Hospital of Leicester NHS Trust- Royal Infirmary
Leicester, , United Kingdom
Queen's Medical College
Nottingham, , United Kingdom
Queens Medical Center
Nottingham, , United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth, , United Kingdom
Countries
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References
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Mank E, Saenz de Pipaon M, Lapillonne A, Carnielli VP, Senterre T, Shamir R, van Toledo L, van Goudoever JB; FIT-04 Study Group. Efficacy and Safety of Enteral Recombinant Human Insulin in Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2022 May 1;176(5):452-460. doi: 10.1001/jamapediatrics.2022.0020.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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FIT-04
Identifier Type: -
Identifier Source: org_study_id
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