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: June 12, 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 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
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: NCT01427725

  Show 189 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: June 12, 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 August 26, 2014