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

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ClinicalTrials.gov Identifier: NCT01427725
Recruitment Status : Completed
First Posted : September 2, 2011
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Mylan Inc.

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 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

Resource links provided by the National Library of Medicine


Group/Cohort
LipaCreon
those with an exposure



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



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Ages Eligible for Study:   Child, Adult, Older Adult
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.

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

Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT01427725     History of Changes
Other Study ID Numbers: P12-894
First Posted: September 2, 2011    Key Record Dates
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