Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis - Full Text View

Purpose

This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment with LipaCreon in order to evaluate the effective and safe use of LipaCreon.

Condition
Cystic Fibrosis Exocrine Pancreatic Insufficiency Pancreatic Diseases Digestive System Diseases

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis Digestive Diseases Pancreatic Diseases

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Number of patients with adverse drug reaction [ Time Frame: Once a year until end of Follow-up period up to 7 years ] [ Designated as safety issue: Yes ]
Number of participants who reported adverse drug reaction. Name of adverse event, Seriousness, Outcome, Causal relation to LipaCreon.
Nutrition assessment items [ Time Frame: At week 52 ] [ Designated as safety issue: No ]
Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

Secondary Outcome Measures:

Overall improvement rating [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
4 grades: Effective, unchanged, aggravation, unassessable
Overall improvement rating [ Time Frame: At week 52 ] [ Designated as safety issue: No ]
4 grades: Effective, unchanged, aggravation, unassessable
Nutrition assessment items [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin
Nutrition assessment items [ Time Frame: At week 4 ] [ Designated as safety issue: No ]
Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin
Nutrition assessment items [ Time Frame: At week 8 ] [ Designated as safety issue: No ]
Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin
Nutrition assessment items [ Time Frame: At week 12 ] [ Designated as safety issue: No ]
Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin
Nutrition assessment items [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin
Nutrition assessment items [ Time Frame: 2nd year ] [ Designated as safety issue: No ]
Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin
Nutrition assessment items [ Time Frame: 3rd year ] [ Designated as safety issue: No ]
Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin
Nutrition assessment items [ Time Frame: 4th year ] [ Designated as safety issue: No ]
Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin
Nutrition assessment items [ Time Frame: 5th year ] [ Designated as safety issue: No ]
Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin
Nutrition assessment items [ Time Frame: 6th year ] [ Designated as safety issue: No ]
Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin
Nutrition assessment items [ Time Frame: 7th year ] [ Designated as safety issue: No ]
Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin
Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention
Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 4 ] [ Designated as safety issue: No ]
Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention
Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 12 ] [ Designated as safety issue: No ]
Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention
Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 8 ] [ Designated as safety issue: No ]
Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention
Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 52 ] [ Designated as safety issue: No ]
Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention
Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention
Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: 3rd year ] [ Designated as safety issue: No ]
Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention
Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: 2nd year ] [ Designated as safety issue: No ]
Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention
Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: 5th year ] [ Designated as safety issue: No ]
Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention
Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: 4th year ] [ Designated as safety issue: No ]
Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention
Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: 7th year ] [ Designated as safety issue: No ]
Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention
Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: 6th year ] [ Designated as safety issue: No ]
Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

Estimated Enrollment:	30
Study Start Date:	November 2011
Estimated Study Completion Date:	March 2018
Estimated Primary Completion Date:	March 2018 (Final data collection date for primary outcome measure)

Groups/Cohorts
LipaCreon those with an exposure

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency

Criteria

Inclusion Criteria

Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency due to cystic fibrosis

Exclusion Criteria

Patients with a history of hypersensitivity to the ingredient of LipaCreon.
Patients with a history of hypersensitivity to porcine protein

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427712

Contacts

Contact: Abbott Japan PMOS Desk	+81-3-4588-4621	ABTJ-PMOS@abbott.com
Contact: Jun Kato, MD., Ph.D.		jun.kato@abbott.com

Locations

Japan
Site Reference ID/Investigator# 65530	Recruiting
Kagawa, Japan
Principal Investigator: Site Reference ID/Investigator# 65530
Site Reference ID/Investigator# 65527	Recruiting
Kagoshima, Japan
Principal Investigator: Site Reference ID/Investigator# 65527
Site Reference ID/Investigator# 65529	Recruiting
Kanazawa, Japan
Principal Investigator: Site Reference ID/Investigator# 65529
Site Reference ID/Investigator# 73813	Recruiting
Nagoya, Japan
Principal Investigator: Site Reference ID/Investigator# 73813
Site reference ID/Investigator # 96698	Recruiting
Nagoya, Japan, 466-8650
Site reference ID/Investigator # 93736	Recruiting
Obu, Japan, 474-8710
Site Reference ID/Investigator# 65528	Recruiting
Sendai, Japan
Principal Investigator: Site Reference ID/Investigator# 65528
Site Reference ID/Investigator# 67122	Recruiting
Tokyo, Japan
Principal Investigator: Site Reference ID/Investigator# 67122
Site Reference ID/Investigator# 88673	Recruiting
Tsukuba, Japan
Principal Investigator: Site Reference ID/Investigator# 88673
Site reference ID/Investigator # 93735	Recruiting
Tsukuba, Japan, 305-8520

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Jun Kato, MD., Ph.D.

Abbott Japan Co.,Ltd

More Information

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01427712 History of Changes
Other Study ID Numbers:	P12-893
Study First Received:	August 31, 2011
Last Updated:	May 16, 2013
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:

Digestive System Diseases
Cystic Fibrosis
Therapeutic Uses
Gastrointestinal Agents

Pancreatic Diseases
Pancrelipase
Exocrine Pancreatic Insufficiency

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Exocrine Pancreatic Insufficiency
Lung Diseases

Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013