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

Study Description

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease
Exocrine Pancreatic Insufficiency; Pancreatic Diseases; Digestive System Diseases

Study Design

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	562 participants
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
Study Start Date :	October 2011
Actual Primary Completion Date :	April 2015
Actual Study Completion Date :	April 2015

Groups and Cohorts

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
LipaCreon; those with an exposure

Outcome Measures

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Number of patients with adverse drug reaction [ Time Frame: At week 52 ]
   Number of participants who report adverse drug reaction. Name of adverse event, Seriousness, Outcome, Causal relation to LipaCreon.
2. Nutrition assessment items [ Time Frame: At week 52 ]
   Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

Secondary Outcome Measures :

1. Overall improvement rating [ Time Frame: At week 24 ]
   Four grades: Effective, unchanged, aggravation, unassessable
2. Overall improvement rating [ Time Frame: At week 52 ]
   Four grades: Effective, unchanged, aggravation, unassessable
3. Nutrition assessment items [ Time Frame: Baseline ]
   Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin
4. Nutrition assessment items [ Time Frame: At week 4 ]
   Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin
5. Nutrition assessment items [ Time Frame: At week 8 ]
   Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin
6. Nutrition assessment items [ Time Frame: At week 24 ]
   Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin
7. Health Related Quality of Life [ Time Frame: Baseline ]
   SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)
8. Health Related Quality of Life [ Time Frame: at week 8 ]
   SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)
9. Health Related Quality of Life [ Time Frame: at week 24 ]
   SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)
10. Health Related Quality of Life [ Time Frame: at week 52 ]
    SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)
11. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: Baseline ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention
12. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 4 ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention
13. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 8 ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention
14. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 24 ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention
15. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 52 ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

Eligibility Criteria

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 189 Study Locations

Sponsors and Collaborators

Mylan Inc.

Investigators

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

More Information

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Mylan Inc.
ClinicalTrials.gov Identifier:	NCT01427725 History of Changes
Other Study ID Numbers:	P12-894
First Posted:	September 2, 2011
Last Update Posted:	June 10, 2015
Last Verified:	May 2015

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