Clinical trial NCT01427712: Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Official title: Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases
Keywords: Digestive System Diseases
Cystic Fibrosis
Therapeutic Uses
Gastrointestinal Agents
Pancreatic Diseases
Pancrelipase
Exocrine Pancreatic Insufficiency
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-02
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency

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.


Eligibility criteria: Inclusion Criteria

* Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency due to cystic fibrosis

Exclusion Criteria

* Patients with a history of hypersensitivity to the ingredient of LipaCreon.
* Patients with a history of hypersensitivity to porcine protein

Primary outcomes:
measure: Number of Patients With Adverse Drug Reaction
timeFrame: 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:
measure: Nutritional Endpoints - BMI
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
measure: Nutritional Endpoints - Serum Total Protein
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
measure: Nutrition Endpoints - Albumin
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
measure: Nutrition Endpoints - Total Cholesterol
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
measure: Nutrition Endpoints - Triglycerides
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
measure: Nutrition Endpoints - Haemoglobin
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
measure: Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
measure: Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
measure: Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
measure: Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
measure: Symptoms Related to Exocrine Pancreatic Insufficiency - Inappetence
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
measure: Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
measure: Degree of General Improvement
timeFrame: At 24 weeks
measure: Degree of General Improvement
timeFrame: At 52 weeks
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 73813
city: Aichi
country: Japan
facility: Site reference ID/Investigator # 96698
city: Aichi
country: Japan
facility: Research facility ID ORG-000141
city: Aichi
country: Japan
facility: Site reference ID/Investigator no. ORG-000842
city: Aichi
country: Japan
facility: Site reference ID/Investigator # 93736
city: Ehime
country: Japan
facility: Research facility ORG-000972
city: Hyōgo
country: Japan
facility: Mylan investigational site A
city: Ibaraki
country: Japan
facility: Site reference ID/Investigator # 93735
city: Ibaraki
country: Japan
facility: Site Reference ID/Investigator# 88673
city: Ishikawa
country: Japan
facility: Site Reference ID/Investigator# 65529
city: Kagawa
country: Japan
facility: Site Reference ID/Investigator# 65530
city: Kagoshima
country: Japan
facility: Site Reference ID/Investigator# 65527
city: Kanagawa
country: Japan
facility: Mylan investigational site C
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 65528
city: Miyagi
country: Japan
facility: Mylan investigational site B
city: Oita
country: Japan
facility: Research facility ID ORG-001138
city: Osaka
country: Japan
facility: Research facility ID ORG-000594
city: Shizuoka
country: Japan
facility: Research facility ORG-000971
city: Tochigi
country: Japan
facility: Site reference ID/Investigator# 117495
city: Tokyo
country: Japan
facility: Research facility no. ORG-001309
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 67122
Study officials:
affiliation: Mylan EPD G.K.
name: Shigenori Haruna
role: STUDY_DIRECTOR
References: