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
|
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Condition or disease |
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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 |
Group/Cohort |
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LipaCreon
those with an exposure
|
- 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
- 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

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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

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 |