Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
- Conditions
- Cystic FibrosisPancreatic DiseasesExocrine Pancreatic InsufficiencyDigestive System Diseases
- Interventions
- Registration Number
- NCT01427712
- Lead Sponsor
- Mylan Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description LipaCreon Pancrelipase 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.
- Primary Outcome Measures
Name Time Method Number of Patients With Adverse Drug Reaction 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). 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
- Secondary Outcome Measures
Name Time Method 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 The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•BMI (height \[only prior to the start of Lipacreon treatment\] and weight)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 The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Serum total proteinNutrition Endpoints - Albumin Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•AlbuminNutrition 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 The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Total cholesterolNutrition Endpoints - Triglycerides Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•TriglyceridesNutrition Endpoints - Haemoglobin Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•HaemoglobinSymptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Steatorrhoea (Yes/No)Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Frequency of bowel movements (times/day)Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Diarrhoea (Yes/No)Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Foul stool odour (Yes/No)Symptoms Related to Exocrine Pancreatic Insufficiency - Inappetence Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Inappetence (Yes/No)Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.
•Abdominal distension (Yes/No)Degree of General Improvement At 52 weeks Degree of general improvement was assessed at 24 weeks after the start of Lipacreon treatment and at the completion of the 52-week observation period, using the following 4 grades:
Improved, unchanged, exacerbated, unassessable
Trial Locations
- Locations (21)
Site reference ID/Investigator # 96698
🇯🇵Aichi, Japan
Research facility ORG-000972
🇯🇵Ehime, Japan
Site Reference ID/Investigator# 65530
🇯🇵Kagawa, Japan
Site Reference ID/Investigator# 73813
🇯🇵Aichi, Japan
Research facility ID ORG-000141
🇯🇵Aichi, Japan
Site reference ID/Investigator # 93736
🇯🇵Aichi, Japan
Site Reference ID/Investigator# 65529
🇯🇵Ishikawa, Japan
Site Reference ID/Investigator# 65528
🇯🇵Miyagi, Japan
Mylan investigational site B
🇯🇵Miyagi, Japan
Research facility ID ORG-001138
🇯🇵Oita, Japan
Site reference ID/Investigator no. ORG-000842
🇯🇵Aichi, Japan
Site Reference ID/Investigator# 88673
🇯🇵Ibaraki, Japan
Mylan investigational site A
🇯🇵Hyōgo, Japan
Site reference ID/Investigator # 93735
🇯🇵Ibaraki, Japan
Mylan investigational site C
🇯🇵Kanagawa, Japan
Site Reference ID/Investigator# 65527
🇯🇵Kagoshima, Japan
Research facility no. ORG-001309
🇯🇵Tokyo, Japan
Research facility ID ORG-000594
🇯🇵Osaka, Japan
Research facility ORG-000971
🇯🇵Shizuoka, Japan
Site reference ID/Investigator# 117495
🇯🇵Tochigi, Japan
Site Reference ID/Investigator# 67122
🇯🇵Tokyo, Japan