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
299	嚢胞性線維症	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	NCT00662675 (ClinicalTrials.gov)	August 2008	17/4/2008	A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency	A Randomized Double-blind (Withdrawal) Phase 3 Study to Evaluate the Efficacy and Tolerability of Pancrelipase MT Capsules Compared With Placebo in the Treatment of Subjects With Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency	Exocrine Pancreatic Insufficiency;Steatorrhea;Malabsorption Syndromes;Cystic Fibrosis	Drug: Pancrease MT 10.5, or MT 21;Drug: Placebo for Pancrease MT 10.5 or MT 21	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	NULL	Completed	7 Years	60 Years	All	40	Phase 3	United States;Canada
2	EUCTR2015-001219-11-Outside-EU/EEA (EUCTR)		31/03/2015	A study of the efficacy and tolerability of pancrelipase microtablet (MT) capsules for the treatment of cystic fibrosis-dependent exocrine pancreatic insufficiency	A randomized double-blind (withdrawal) phase 3 study to evaluate the efficacy and tolerability of pancrelipase MT capsules compared with placebo in the treatment of subjects with cystic fibrosis-dependent exocrine pancreatic insufficiency	Cystic fibrosis MedDRA version: 17.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Trade Name: PANCREASE MT Product Name: PANCREASE MT INN or Proposed INN: pancrelipase Other descriptive name: PANCRELIPASE AMYLASE	Johnson & Johnson Pharmaceutical Research and Development, L.L.C.	NULL	NA			Female: yes Male: yes	40	Phase 3	United States;Canada

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

NCT00662675
(ClinicalTrials.gov)

August 2008

17/4/2008

A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency

A Randomized Double-blind (Withdrawal) Phase 3 Study to Evaluate the Efficacy and Tolerability of Pancrelipase MT Capsules Compared With Placebo in the Treatment of Subjects With Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency

Exocrine Pancreatic Insufficiency;Steatorrhea;Malabsorption Syndromes;Cystic Fibrosis

Drug: Pancrease MT 10.5, or MT 21;Drug: Placebo for Pancrease MT 10.5 or MT 21

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

NULL

Completed

7 Years

60 Years

All

Phase 3

United States;Canada

EUCTR2015-001219-11-Outside-EU/EEA
(EUCTR)

31/03/2015

A study of the efficacy and tolerability of pancrelipase microtablet (MT) capsules for the treatment of cystic fibrosis-dependent exocrine pancreatic insufficiency

A randomized double-blind (withdrawal) phase 3 study to evaluate the efficacy and tolerability of pancrelipase MT capsules compared with placebo in the treatment of subjects with cystic fibrosis-dependent exocrine pancreatic insufficiency

Cystic fibrosis
MedDRA version: 17.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Trade Name: PANCREASE MT
Product Name: PANCREASE MT
INN or Proposed INN: pancrelipase
Other descriptive name: PANCRELIPASE AMYLASE

Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

NULL

Female: yes
Male: yes

Phase 3

United States;Canada