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

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.
 
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.

Tracking Information
First Submitted Date August 31, 2011
First Posted Date September 2, 2011
Last Update Posted Date June 10, 2015
Study Start Date October 2011
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 31, 2011)
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01427725 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 31, 2011)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency
Condition
  • Exocrine Pancreatic Insufficiency
  • Pancreatic Diseases
  • Digestive System Diseases
Intervention Not Provided
Study Groups/Cohorts LipaCreon
those with an exposure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 9, 2015)
562
Original Estimated Enrollment
 (submitted: August 31, 2011)
500
Actual Study Completion Date April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01427725
Other Study ID Numbers P12-894
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mylan Inc.
Study Sponsor Mylan Inc.
Collaborators Not Provided
Investigators
Study Director: Jun Kato, MD.,Ph.D. Abbott Japan Co.,Ltd
PRS Account Mylan Inc.
Verification Date May 2015