Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency

PHASE3CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

December 31, 2012

Study Completion Date

December 31, 2012

Conditions
Pancreatic Exocrine Insufficiency
Interventions
DRUG

Pancreatin

Doses of Pancreatin \<2500 lipase u/kg/feed or \<4000 lipase U/g fat/intake or \<10000 lipase U/kg/day given orally are used

Trial Locations (9)

117997

Site Reference ID/Investigator# 80693, Moscow

150003

Site Reference ID/Investigator# 80696, Yaroslavl

194156

Site Reference ID/Investigator# 80694, Saint Petersburg

394036

Site Reference ID/Investigator# 80697, Voronezh

460000

Site Reference ID/Investigator# 80715, Orenburg

630091

Site Reference ID/Investigator# 80698, Novosibirsk

634050

Site Reference ID/Investigator# 80714, Tomsk

656019

Site Reference ID/Investigator# 80716, Barnaul

Unknown

Site Reference ID/Investigator# 80713, Novosibirsk

All Listed Sponsors
lead

Abbott Products

INDUSTRY

NCT01747330 - Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency | Biotech Hunter | Biotech Hunter