Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

July 31, 2014

Study Completion Date

August 31, 2014

Conditions
Pancreatic InsufficiencyCystic FibrosisDigestive System DiseasesLung DiseasesRespiratory Tract Diseases
Interventions
DRUG

Burlulipase

Burlulipase oral solution will be taken with meals and snacks for 5 to 7 days

DRUG

Placebo (Caramel in sterile water)

Placebo will be taken with meals and snacks for 5 to 7 days

Trial Locations (9)

17033

Penn State Milton S. Hershey Medical Center, Hershey

26506

West Virginia University Research Corporation, Morgantown

32207

Nemours Children's Clinic, Jacksonville

32504

Nemours Children's Clinic, Pensacola

44106

University Hospitals Case Medical Center, Cleveland

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

45404

The Children's Medical Center of Dayton, Dayton

52242

The University of Iowa, Iowa City

67214

Via Cristi Hospitals Wichita, Inc., Wichita

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

Nordmark Arzneimittel GmbH & Co. KG

INDUSTRY