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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Abbott
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01427712
First received: August 31, 2011
Last updated: June 20, 2014
Last verified: June 2014
  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:


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: December 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
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: 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 no. ORG-000842 Recruiting
Aichi, Japan, 470-0224
Site reference ID/Investigator # 96698 Recruiting
Aichi, Japan, 466-8650
Site reference ID/Investigator # 93736 Recruiting
Aichi, Japan, 474-8710
Site Reference ID/Investigator# 73813 Recruiting
Aichi, Japan, 462-8508
Principal Investigator: Site Reference ID/Investigator# 73813         
Research facility ORG-000972 Recruiting
Ehime, Japan, 794-0006
Site reference ID/Investigator # 93735 Recruiting
Ibaraki, Japan, 305-8520
Site Reference ID/Investigator# 88673 Recruiting
Ibaraki, Japan, 305-8558
Principal Investigator: Site Reference ID/Investigator# 88673         
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 ORG-000971 Recruiting
Shizuoka, Japan, 438-8550
Site reference ID/Investigator# 117495 Recruiting
Tochigi, Japan, 329-0431
Site Reference ID/Investigator# 67122 Recruiting
Tokyo, Japan, 157-8535
Principal Investigator: Site Reference ID/Investigator# 67122         
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: June 20, 2014
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 July 28, 2014