DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
298	遺伝性膵炎	1

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	NCT00559364 (ClinicalTrials.gov)	November 2007	14/11/2007	Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea	A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled, Phase III Study to Assess the Safety and Efficacy of Viokase® 16 for the Correction of Steatorrhea in Patients With Exocrine Pancreatic Insufficiency	Exocrine Pancreatic Insufficiency;Chronic Pancreatitis;Pancreatectomy	Drug: Viokase® 16;Drug: Placebo;Drug: Proton pump inhibitor (PPI);Drug: Omeprazole	Forest Laboratories	NULL	Completed	18 Years	80 Years	All	50	Phase 3	United States;Canada;Poland;Slovakia;Germany

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

NCT00559364
(ClinicalTrials.gov)

November 2007

14/11/2007

Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea

A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled, Phase III Study to Assess the Safety and Efficacy of Viokase® 16 for the Correction of Steatorrhea in Patients With Exocrine Pancreatic Insufficiency

Exocrine Pancreatic Insufficiency;Chronic Pancreatitis;Pancreatectomy

Drug: Viokase® 16;Drug: Placebo;Drug: Proton pump inhibitor (PPI);Drug: Omeprazole

Forest Laboratories

NULL

Completed

18 Years

80 Years

All

Phase 3

United States;Canada;Poland;Slovakia;Germany