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

PHASE3TerminatedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

October 9, 2016

Primary Completion Date

April 25, 2018

Study Completion Date

April 25, 2018

Conditions
Premature Birth of NewbornIntestinal Malabsorption
Interventions
DRUG

NTRA-2112

DRUG

Placebo

Trial Locations (50)

27834

Vidant Medical Center, Greenville

29425

Medical University of South Carolina, Charleston

37232

Vanderbilt University Medical Center, Nashville

73104

University of Oklahoma Health Sciences Center, Oklahoma City

Unknown

AZ Sint-Jan, Bruges

UZ Brussel, Brussels

CHR de la Citadelle, Liège

CHC Cliniques Saint-Vincent, Rocourt

GZA Sint-Augustinus, Wilrijk

CHRU Nancy, Maternité Régionale, Nancy

CHU Necker-Enfants Malades, Paris

CHU - Hôpital Sud, Rennes

Kinderklinik, Evangelisches Waldkrankenhaus Spandau, Berlin

Klinik und Poliklinik fur Kinder-und Jugendmedizin, Universitaetsklinikum Carl Gustav Carus Dresden, Dresden

Klinik fur Neugeborene, Kinder und Jugendliche, Universitatsklinik der Paracelsus Medizinischen Privatuniversitat, Nuremberg

Klinik fuer Kinder und Jugendliche, Helios Klinikum Pforzheim, Pforzheim

Kinderklinik, Evangelisches Waldkrankenhaus, Spandau

DE KK Gyermekklinika, Debrecen

Szegedi Tudomanyegyetem Szent Gyorgyi Albert Klinikai Kozpont Gyermekgyogyaszati klinika Koraszulott Intenzív Osztaly, Szeged

Fejéktató Kórhz Újszülött, Csecsemő és Gyermekosztály - Megyei Szent György Egyetemi, Székesfehérvár

Csolnoky Ferenc Korhaz, Veszprém

Barzilai MC, Ashkelon

Soroka Medical Center, Beersheba

Bnai Zion MC, Haifa

Rambam Health Care Campus, Haifa

Laniado, Netanya

Schneider Children's Medical Center, Petah Tikva

Sheba MC, Ramat Gan

Tel Aviv Sourasky MC, Tel Aviv

Presidio Ospedaliero G. Salesi - AOUI Ospedali Riuniti di Ancona, Ancona

Granda Ospedale Maggiore Policlinico, Milan

"Ospedale dei Bambini V.Buzzi- Azienda ICP", Milan

Azienda Ospedaliera San Gerardo, Monza

Policlinico Gemelli, Rome

Azienda Ospedaliero Universitaria, Udine

Ospedale F. Del Ponte - Azienda Ospedaliera di Varese, Varese

AMC - Academic Medical Center, Amsterdam

UMC Groningen (UMCG), Beatrix Kinderziekenhuis, Groningen

Isala Klinieken, Zwolle

Vall d'Hebron, Barcelona

Hospital General Universitario Gregorio Marañon, Madrid

La-Paz, Madrid

Hospital Universitario Virgen de la Arrixaca, Murcia

CHUS - Complejo Hospitalario Universitario de Santiago, Santiago

Hospital Universitario La Fe, Valencia

Bradford Royal Infirmary, Bradford

University Hospital of Leicester NHS Trust- Royal Infirmary, Leicester

Queen's Medical College, Nottingham

Queens Medical Center, Nottingham

Portsmouth Hospitals NHS Trust, Portsmouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Elgan Pharma Ltd.

INDUSTRY