DDrare: Database of Drug Development for Rare Diseases

ID	Disease name (Link within this page)	Number of trials
299	Cystic fibrosis	2

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00217204 (ClinicalTrials.gov)	July 2005	13/9/2005	An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption	A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Effectiveness of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers With Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption	Cystic Fibrosis;Steatorrhea	Drug: Pancrelipase microtablets	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	NULL	Completed	6 Months	30 Months	Both	18	Phase 2	Belgium;Netherlands
2	EUCTR2005-001438-34-BE (EUCTR)		15/07/2005	A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Efficacy of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers with Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption	A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Efficacy of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers with Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption	Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption	Trade Name: Panzytrat® ok Product Name: Pancrelipase Microtablets Product Code: N/A INN or Proposed INN: Pancreatin	McNeil Consumer and Specialty Pharmaceuticals	NULL	NA			Female: yes Male: yes	20	Phase 2	Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT00217204
(ClinicalTrials.gov)

July 2005

13/9/2005

An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption

A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Effectiveness of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers With Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption

Cystic Fibrosis;Steatorrhea

Drug: Pancrelipase microtablets

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

NULL

Completed

6 Months

30 Months

Both

Phase 2

Belgium;Netherlands

EUCTR2005-001438-34-BE
(EUCTR)

15/07/2005

A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Efficacy of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers with Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption

Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption

Trade Name: Panzytrat® ok
Product Name: Pancrelipase Microtablets
Product Code: N/A
INN or Proposed INN: Pancreatin

McNeil Consumer and Specialty Pharmaceuticals

NULL

Female: yes
Male: yes

Phase 2

Belgium