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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01427725
First received: August 31, 2011
Last updated: March 3, 2014
Last verified: February 2014
  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 Abbott:

Primary Outcome Measures:
  • Number of patients with adverse drug reaction [ Time Frame: At week 52 ] [ Designated as safety issue: Yes ]
    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 ] [ 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 ]
    Four grades: Effective, unchanged, aggravation, unassessable

  • Overall improvement rating [ Time Frame: At week 52 ] [ Designated as safety issue: No ]
    Four 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 24 ] [ Designated as safety issue: No ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

  • Health Related Quality of Life [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)

  • Health Related Quality of Life [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
    SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)

  • Health Related Quality of Life [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
    SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)

  • Health Related Quality of Life [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
    SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)

  • 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 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 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: At week 52 ] [ Designated as safety issue: No ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention


Estimated Enrollment: 500
Study Start Date: October 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427725

  Show 126 Study Locations
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: NCT01427725     History of Changes
Other Study ID Numbers: P12-894
Study First Received: August 31, 2011
Last Updated: March 3, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:
Digestive System Diseases
Therapeutic Uses
Pancreatectomy
Gastrointestinal Agents
Pancreatic Diseases
Pancrelipase
Exocrine Pancreatic Insufficiency

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Pancreatic Diseases
Exocrine Pancreatic Insufficiency
Pancreatitis, Chronic
Pancreatitis
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014