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	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	NCT01430234 (ClinicalTrials.gov)	October 2011	1/9/2011	Enzyme Suppletion in Exocrine Pancreatic Dysfunction	Enzyme Substitution in Exocrine Pancreatic Insufficiency; Self Administration Against a Fixed Dose Regimen	Chronic Pancreatitis;Exocrine Pancreatic Insufficiency	Drug: Panzytrat 25.000 FIP-E units of Lipase	Foundation for Liver Research	Axcan Pharma	Completed	18 Years	90 Years	Both	10	Phase 4	Netherlands
2	EUCTR2004-002468-89-DE (EUCTR)	28/10/2004	23/09/2004	A RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PANCREATIN VS. PLACEBO FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY - Pancreatin vs. Placebo in Patients with Pancreatic Exocrine Insufficiency	A RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PANCREATIN VS. PLACEBO FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY - Pancreatin vs. Placebo in Patients with Pancreatic Exocrine Insufficiency	The purpose of this clinical trial is to evaluate the clinical efficacy and safety of a capsule containing enteric-coated porcine pancreatin microfilm tablets in comparison with placebo in the treatment of pancreatic exocrine insufficiency due to chronic pancreatitis. MedDRA version: 7.0;Level: LLT;Classification code 10033622	Trade Name: Panzytrat 25.000 Product Name: Panzytrat 25.000 Product Code: Pancreatin INN or Proposed INN: Pancreatin	Axcan Pharma S.A.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 4	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

NCT01430234
(ClinicalTrials.gov)

October 2011

1/9/2011

Enzyme Suppletion in Exocrine Pancreatic Dysfunction

Enzyme Substitution in Exocrine Pancreatic Insufficiency; Self Administration Against a Fixed Dose Regimen

Chronic Pancreatitis;Exocrine Pancreatic Insufficiency

Drug: Panzytrat 25.000 FIP-E units of Lipase

Foundation for Liver Research

Axcan Pharma

Completed

18 Years

90 Years

Both

Phase 4

Netherlands

EUCTR2004-002468-89-DE
(EUCTR)

28/10/2004

23/09/2004

A RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PANCREATIN VS. PLACEBO FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY - Pancreatin vs. Placebo in Patients with Pancreatic Exocrine Insufficiency

The purpose of this clinical trial is to evaluate the clinical efficacy and safety of a capsule containing enteric-coated porcine pancreatin microfilm tablets in comparison with placebo in the treatment of pancreatic exocrine insufficiency due to chronic pancreatitis.
MedDRA version: 7.0;Level: LLT;Classification code 10033622

Trade Name: Panzytrat 25.000
Product Name: Panzytrat 25.000
Product Code: Pancreatin
INN or Proposed INN: Pancreatin

Axcan Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Germany