Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency
This study has been completed.
Sponsor:
Mylan Inc.
Information provided by (Responsible Party):
Mylan Inc.
ClinicalTrials.gov Identifier:
NCT01427725
First received: August 31, 2011
Last updated: June 9, 2015
Last verified: May 2015
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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 Mylan Inc.:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Enrollment: | 562 |
| Study Start Date: | October 2011 |
| Study Completion Date: | April 2015 |
| Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
LipaCreon
those with an exposure
|
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| 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.
Contacts and Locations
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427725
Show 189 Study Locations
Sponsors and Collaborators
Mylan Inc.
Investigators
| Study Director: | Jun Kato, MD.,Ph.D. | Abbott Japan Co.,Ltd |
More Information
| Responsible Party: | Mylan Inc. |
| ClinicalTrials.gov Identifier: | NCT01427725 History of Changes |
| Other Study ID Numbers: |
P12-894 |
| Study First Received: | August 31, 2011 |
| Last Updated: | June 9, 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 Pancreatic Diseases Digestive System Diseases Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on May 24, 2017