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

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ClinicalTrials.gov Identifier: NCT01427712
Recruitment Status : Recruiting
First Posted : September 2, 2011
Last Update Posted : November 29, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Cystic Fibrosis Exocrine Pancreatic Insufficiency Pancreatic Diseases Digestive System Diseases

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Study Start Date : December 2011
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
LipaCreon
those with an exposure


Outcome Measures

Primary Outcome Measures :
  1. Number of patients with adverse drug reaction [ Time Frame: Once a year until end of Follow-up period up to 7 years ]
    Number of participants who reported 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 ]
    4 grades: Effective, unchanged, aggravation, unassessable

  2. Overall improvement rating [ Time Frame: At week 52 ]
    4 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 12 ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

  7. Nutrition assessment items [ Time Frame: At week 24 ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

  8. Nutrition assessment items [ Time Frame: 2nd year ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

  9. Nutrition assessment items [ Time Frame: 3rd year ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

  10. Nutrition assessment items [ Time Frame: 4th year ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

  11. Nutrition assessment items [ Time Frame: 5th year ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

  12. Nutrition assessment items [ Time Frame: 6th year ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

  13. Nutrition assessment items [ Time Frame: 7th year ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

  14. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: Baseline ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

  15. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 4 ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

  16. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 12 ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

  17. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 8 ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

  18. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 52 ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

  19. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 24 ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

  20. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: 3rd year ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

  21. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: 2nd year ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

  22. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: 5th year ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

  23. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: 4th year ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

  24. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: 7th year ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

  25. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: 6th year ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 99 Years   (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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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# 73813 Recruiting
Aichi, Japan, 462-8508
Principal Investigator: Site Reference ID/Investigator# 73813         
Site reference ID/Investigator # 96698 Recruiting
Aichi, Japan, 466-8650
Research facility ID ORG-000141 Recruiting
Aichi, Japan, 467-8602
Site reference ID/Investigator no. ORG-000842 Recruiting
Aichi, Japan, 470-0224
Site reference ID/Investigator # 93736 Completed
Aichi, Japan, 474-8710
Research facility ORG-000972 Recruiting
Ehime, Japan, 794-0006
Site reference ID/Investigator # 93735 Recruiting
Ibaraki, Japan, 305-8520
Site Reference ID/Investigator# 88673 Terminated
Ibaraki, Japan, 305-8558
Site Reference ID/Investigator# 65529 Recruiting
Ishikawa, Japan, 920-8641
Principal Investigator: Site Reference ID/Investigator# 65529         
Site Reference ID/Investigator# 65530 Recruiting
Kagawa, Japan, 760-0017
Principal Investigator: Site Reference ID/Investigator# 65530         
Site Reference ID/Investigator# 65527 Recruiting
Kagoshima, Japan, 890-8520
Principal Investigator: Site Reference ID/Investigator# 65527         
Site Reference ID/Investigator# 65528 Recruiting
Miyagi, Japan, 980-0872
Principal Investigator: Site Reference ID/Investigator# 65528         
Research facility ID ORG-001138 Recruiting
Oita, Japan, 874-0011
Research facility ID ORG-000594 Terminated
Osaka, Japan, 534-0021
Research facility ORG-000971 Recruiting
Shizuoka, Japan, 438-8550
Site reference ID/Investigator# 117495 Recruiting
Tochigi, Japan, 329-0431
Research facility no. ORG-001309 Recruiting
Tokyo, Japan, 108-8329
Site Reference ID/Investigator# 67122 Recruiting
Tokyo, Japan, 157-8535
Principal Investigator: Site Reference ID/Investigator# 67122         
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: NCT01427712     History of Changes
Other Study ID Numbers: P12-893
First Posted: September 2, 2011    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: October 2016

Keywords provided by Mylan Inc.:
Digestive System Diseases
Cystic Fibrosis
Therapeutic Uses
Gastrointestinal Agents
Pancreatic Diseases
Pancrelipase
Exocrine Pancreatic Insufficiency

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Fibrosis
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases