Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
1 other identifier
observational
24
1 country
21
Brief Summary
This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment with LipaCreon in order to evaluate the effective and safe use of LipaCreon.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2011
Longer than P75 for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 31, 2011
CompletedFirst Posted
Study publicly available on registry
September 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedResults Posted
Study results publicly available
June 10, 2022
CompletedJune 10, 2022
March 1, 2022
6.6 years
August 31, 2011
June 11, 2021
March 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients With Adverse Drug Reaction
An adverse event (AE) was defined as any unfavourable or unintended disease, or symptom or sign of such a disease, or abnormal laboratory finding that occurred in a patient who received Lipacreon, whether or not considered related to the medicinal product. Also, an AE for which the relationship with Lipacreon could not be ruled out was regarded as an adverse drug reaction (ADR). 1. Related : There is a temporal relationship between the use of the medicinal product and the onset of an AE, or a relapse with readministration,where other factors are less likely to be involved. 2. Relationship cannot be ruled out : There are other potential factors although there is a temporal relationship between the use of the medicinal product and the onset of an AE
From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 7 years in the study completers (From date of dosage start, up to 7 years).
Secondary Outcomes (14)
Nutritional Endpoints - BMI
Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Nutritional Endpoints - Serum Total Protein
Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Nutrition Endpoints - Albumin
Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Nutrition Endpoints - Total Cholesterol
Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Nutrition Endpoints - Triglycerides
Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
- +9 more secondary outcomes
Study Arms (1)
LipaCreon
In general, pancrelipase 600 mg/dose was orally administered immediately after a meal, 3 times a day. Also, the dose was adjusted appropriately according to the patient's condition.
Interventions
Eligibility Criteria
Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency
You may qualify if:
- Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency due to cystic fibrosis
You may not qualify if:
- Patients with a history of hypersensitivity to the ingredient of LipaCreon.
- Patients with a history of hypersensitivity to porcine protein
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mylan Inc.lead
Study Sites (21)
Site Reference ID/Investigator# 73813
Aichi, 462-8508, Japan
Site reference ID/Investigator # 96698
Aichi, 466-8650, Japan
Research facility ID ORG-000141
Aichi, 467-8602, Japan
Site reference ID/Investigator no. ORG-000842
Aichi, 470-0224, Japan
Site reference ID/Investigator # 93736
Aichi, 474-8710, Japan
Research facility ORG-000972
Ehime, 794-0006, Japan
Mylan investigational site A
Hyōgo, 660-8550, Japan
Site reference ID/Investigator # 93735
Ibaraki, 305-8520, Japan
Site Reference ID/Investigator# 88673
Ibaraki, 305-8558, Japan
Site Reference ID/Investigator# 65529
Ishikawa, 920-8641, Japan
Site Reference ID/Investigator# 65530
Kagawa, 760-0017, Japan
Site Reference ID/Investigator# 65527
Kagoshima, 890-8520, Japan
Mylan investigational site C
Kanagawa, 232-8555, Japan
Site Reference ID/Investigator# 65528
Miyagi, 980-0872, Japan
Mylan investigational site B
Miyagi, 989-3126, Japan
Research facility ID ORG-000594
Osaka, 534-0021, Japan
Research facility ID ORG-001138
Ōita, 874-0011, Japan
Research facility ORG-000971
Shizuoka, 438-8550, Japan
Site reference ID/Investigator# 117495
Tochigi, 329-0431, Japan
Research facility no. ORG-001309
Tokyo, 108-8329, Japan
Site Reference ID/Investigator# 67122
Tokyo, 157-8535, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical affairs manager
- Organization
- Medical affairs
Study Officials
- STUDY DIRECTOR
Shigenori Haruna
Mylan EPD G.K.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2011
First Posted
September 2, 2011
Study Start
August 1, 2011
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
June 10, 2022
Results First Posted
June 10, 2022
Record last verified: 2022-03