Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency - Full Text View

Purpose

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

Condition
Exocrine Pancreatic Insufficiency Pancreatic Diseases Digestive System Diseases


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Pancreatectomy and Other Conditions Except Cystic Fibrosis

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis hereditary pancreatitis

MedlinePlus related topics: Digestive Diseases Pancreatic Diseases

Genetic and Rare Diseases Information Center resources: Cystic Fibrosis

U.S. FDA Resources

Further study details as provided by Mylan Inc.:

Primary Outcome Measures:

Number of patients with adverse drug reaction [ Time Frame: At week 52 ] [ Designated as safety issue: Yes ]
Number of participants who report 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 ]
Four grades: Effective, unchanged, aggravation, unassessable
Overall improvement rating [ Time Frame: At week 52 ] [ Designated as safety issue: No ]
Four 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 24 ] [ Designated as safety issue: No ]
Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin
Health Related Quality of Life [ Time Frame: Baseline ] [ Designated as safety issue: No ]
SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)
Health Related Quality of Life [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)
Health Related Quality of Life [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)
Health Related Quality of Life [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)
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 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 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: At week 52 ] [ Designated as safety issue: No ]
Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention


Enrollment:	562
Study Start Date:	October 2011
Study Completion Date:	April 2015
Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts
LipaCreon those with an exposure

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01427725

Show 189 Study Locations

Sponsors and Collaborators

Mylan Inc.

Investigators


Study Director:	Jun Kato, MD.,Ph.D.	Abbott Japan Co.,Ltd

More Information


Responsible Party:	Mylan Inc.
ClinicalTrials.gov Identifier:	NCT01427725 History of Changes
Other Study ID Numbers:	P12-894
Study First Received:	August 31, 2011
Last Updated:	June 9, 2015
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mylan Inc.:


Digestive System Diseases Therapeutic Uses Pancreatectomy Gastrointestinal Agents	Pancreatic Diseases Pancrelipase Exocrine Pancreatic Insufficiency

Additional relevant MeSH terms:


Exocrine Pancreatic Insufficiency Digestive System Diseases Gastrointestinal Diseases Pancreatic Diseases

ClinicalTrials.gov processed this record on September 27, 2016