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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01427725
First Posted: September 2, 2011
Last Update Posted: June 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mylan Inc.
  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:


Further study details as provided by Mylan Inc.:

Primary Outcome Measures:
  • 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.

  • Nutrition assessment items [ Time Frame: At week 52 ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin


Secondary Outcome Measures:
  • Overall improvement rating [ Time Frame: At week 24 ]
    Four grades: Effective, unchanged, aggravation, unassessable

  • Overall improvement rating [ Time Frame: At week 52 ]
    Four grades: Effective, unchanged, aggravation, unassessable

  • Nutrition assessment items [ Time Frame: Baseline ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

  • Nutrition assessment items [ Time Frame: At week 4 ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

  • Nutrition assessment items [ Time Frame: At week 8 ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

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

  • Health Related Quality of Life [ Time Frame: Baseline ]
    SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)

  • Health Related Quality of Life [ Time Frame: at week 8 ]
    SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)

  • Health Related Quality of Life [ Time Frame: at week 24 ]
    SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)

  • Health Related Quality of Life [ Time Frame: at week 52 ]
    SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)

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

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

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

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

  • Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 52 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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): 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
First Submitted: August 31, 2011
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