Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic

PHASE2CompletedINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

December 31, 2013

Study Completion Date

March 31, 2014

Conditions
Infantile Colic
Interventions
DRUG

Nepadutant oral solution

Oral administration once daily for 7 days

DRUG

Nepadutant oral solution

Oral administration once daily for 7 days

DRUG

Placebo matching Nepadutant oral solution

Oral administration once daily for 7 days

Trial Locations (9)

80337

Dr. von Haunersches Kinderspital Ludwig Maximilians Universität München, München

117997

Federal Scientific Clinical Center of Children Hematology, Oncology and Immunology, Moscow

119331

Moscow State Healthcare Institution Municipal Pediatric health center № 10, Moscow

119991

Moscow State Medical University, Moscow

123317

Federal Scientific Clinical Center of Children Hematology, Oncology and Immunology, Moscow

194100

St. Petersburg State Pediatric Medical Academy, Saint Petersburg

199191

St. Petersburg State Institution of Healthcare Municipal Pediatric health center № 35, Saint Petersburg

20-093

Klinika Patologii Noworodkow, Niemowlat I Kardiologii, Dzieciecy Szpital Kliniczny, Lublin

SE-901 85

Pediatrics Department of Clinical sciences Umeå university, Umeå

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Menarini Group

INDUSTRY

NCT01258153 - Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic | Biotech Hunter | Biotech Hunter