Clinical trial NCT01427725: Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases
Keywords: Digestive System Diseases
Therapeutic Uses
Pancreatectomy
Gastrointestinal Agents
Pancreatic Diseases
Pancrelipase
Exocrine Pancreatic Insufficiency
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-02
Enrollment: 579
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 receiving the treatment with LipaCreon for a long term in order to evaluate the effective and safe use of LipaCreon.

Detailed description: Criteria for evaluation:

1. Adverse events
2. Nutritional endpoints

   * BMI (height \[only prior to the start of Lipacreon treatment\] and weight)
   * Serum total protein
   * Albumin
   * Total cholesterol
   * Triglycerides
   * Haemoglobin
3. Symptoms related to exocrine pancreatic insufficiency

   * Steatorrhoea
   * Frequency of bowel movements
   * Diarrhoea
   * Foul stool odour
   * Decreased appetite
   * Abdominal distension
4. Patient's quality of life (QOL)
5. Degree of general improvement

Eligibility 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.

Primary outcomes:
measure: Number of Patients With Adverse Drug Reaction
timeFrame: At week 52
Secondary outcomes:
measure: Degree of General Improvement
timeFrame: At week 24
measure: Degree of General Improvement
timeFrame: At week 52
measure: Nutritional Endpoints - BMI
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
measure: Nutritional Endpoints - Serum Total Protein
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
measure: Nutrition Endpoints - Albumin
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
measure: Nutrition Endpoints - Total Cholesterol
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
measure: Patient's Quality of Life - Physical Health (Summary)
timeFrame: Baseline, 8 weeks, 24 weeks, and 52 weeks
measure: Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
measure: Nutrition Endpoints - Triglycerides
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
measure: Nutrition Endpoints - Haemoglobin
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
measure: Patient's Quality of Life - Mental Health (Summary)
timeFrame: Baseline, 8 weeks, 24 weeks, and 52 weeks
measure: Patient's Quality of Life - General Health
timeFrame: Baseline, 8 weeks, 24 weeks, and 52 weeks
measure: Patient's Quality of Life - Physical Functioning
timeFrame: Baseline, 8 weeks, 24 weeks, and 52 weeks
measure: Patient's Quality of Life - Role Physical
timeFrame: Baseline, 8 weeks, 24 weeks, and 52 weeks
measure: Patient's Quality of Life - Body Pain
timeFrame: Baseline, 8 weeks, 24 weeks, and 52 weeks
measure: Patient's Quality of Life - Vitality
timeFrame: Baseline, 8 weeks, 24 weeks, and 52 weeks
measure: Patient's Quality of Life - Social Functioning
timeFrame: Baseline, 8 weeks, 24 weeks, and 52 weeks
measure: Patient's Quality of Life - Mental Health
timeFrame: Baseline, 8 weeks, 24 weeks, and 52 weeks
measure: Patient's Quality of Life - Role Emotional
timeFrame: Baseline, 8 weeks, 24 weeks, and 52 weeks
measure: Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
measure: Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
measure: Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
measure: Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
measure: Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension
timeFrame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research facility ID ORG-000247
city: Aichi
country: Japan
facility: Research facility ID ORG-000216
city: Aichi
country: Japan
facility: Research facility ID ORG-000214
city: Aichi
country: Japan
facility: Research facility ID ORG-000215
city: Aichi
country: Japan
facility: Research facility ORG-000096
city: Aichi
country: Japan
facility: Research facility ORG-000086
city: Aichi
country: Japan
facility: Research facility ORG-000120
city: Aichi
country: Japan
facility: Research facility ORG-000119
city: Aichi
country: Japan
facility: Research facility ID ORG-000208
city: Aichi
country: Japan
facility: Site reference ID/Investigator # 75775
city: Aichi
country: Japan
facility: Research facility ID ORG-000256
city: Akita
country: Japan
facility: Site Reference ID/Investigator# 68371
city: Akita
country: Japan
facility: Site Reference ID/Investigator# 71098
city: Akita
country: Japan
facility: Research facility ORG-000222
city: Aomori
country: Japan
facility: Research facility ORG-000129
city: Aomori
country: Japan
facility: Research facility ORG-000133
city: Chiba
country: Japan
facility: Site Reference ID/Investigator# 68378
city: Chiba
country: Japan
facility: Site Reference ID/Investigator# 75790
city: Chiba
country: Japan
facility: Research facility ORG-000162
city: Chiba
country: Japan
facility: site REference ID/Investigator# 75798
city: Chiba
country: Japan
facility: Research facility ID ORG-000246
city: Chiba
country: Japan
facility: Site reference ID/Investigator# 88676
city: Chiba
country: Japan
facility: Research facility ORG-000118
city: Ehime
country: Japan
facility: Research facility ID ORG-000251
city: Ehime
country: Japan
facility: Research facility ID ORG-000232
city: Ehime
country: Japan
facility: Research facility ORG-000233
city: Ehime
country: Japan
facility: Research facility ORG-000130
city: Fukui
country: Japan
facility: Research facility ID ORG-000271
city: Fukui
country: Japan
facility: Site reference ID/Investigator # 88674
city: Fukuoka
country: Japan
facility: Research facility ORG-000094
city: Fukuoka
country: Japan
facility: Research facility ID ORG-000269
city: Fukuoka
country: Japan
facility: Investigator ID 117496
city: Fukuoka
country: Japan
facility: Research facility ID ORG-000229
city: Fukuoka
country: Japan
facility: Research facility ORG-000088
city: Fukuoka
country: Japan
facility: Research facility ORG-000098
city: Fukuoka
country: Japan
facility: Research facility ORG-000104
city: Fukuoka
country: Japan
facility: Research facility ORG-000091
city: Fukuoka
country: Japan
facility: Research facility ORG-000165
city: Fukuoka
country: Japan
facility: Research facility ID ORG-000262
city: Fukuoka
country: Japan
facility: Research facility ORG-000114
city: Fukushima
country: Japan
facility: Site Reference ID/Investigator# 84554
city: Fukushima
country: Japan
facility: Research facility ID ORG-000207
city: Fukushima
country: Japan
facility: Research facility ORG-000136
city: Fukushima
country: Japan
facility: Research facility ID ORG-000177
city: Gifu
country: Japan
facility: Research facility ID ORG-000238
city: Gifu
country: Japan
facility: Site reference ID/Investigator# 91833
city: Gunma
country: Japan
facility: Research facility ORG-000139
city: Gunma
country: Japan
facility: Research facility ID ORG-000272
city: Gunma
country: Japan
facility: Site reference ID/Investigator # 84557
city: Hiroshima
country: Japan
facility: Research facility ORG-000156
city: Hiroshima
country: Japan
facility: Research facility ID ORG-000241
city: Hiroshima
country: Japan
facility: Research facility ID ORG-000203
city: Hiroshima
country: Japan
facility: Site reference ID/Investigator # 91835
city: Hiroshima
country: Japan
facility: Site Reference ID/Investigator# 88698
city: Hiroshima
country: Japan
facility: Site Reference ID/Investigator# 84515
city: Hiroshima
country: Japan
facility: Research facility ORG-000155
city: Hokkaido
country: Japan
facility: Research facility ID ORG-000213
city: Hokkaido
country: Japan
facility: Research facility ORG-000097
city: Hokkaido
country: Japan
facility: Research facility ID ORG-000220
city: Hokkaido
country: Japan
facility: Research facility ID/Investigator # ORG-000221 / 86896
city: Hokkaido
country: Japan
facility: Site Reference ID/Investigator# 84535
city: Hokkaido
country: Japan
facility: Research facility ID ORG-000250
city: Hokkaido
country: Japan
facility: Site Reference ID# 84573
city: Hokkaido
country: Japan
facility: Research facility ID ORG-000223
city: Hokkaido
country: Japan
facility: Research facility ID ORG-000201
city: Hokkaido
country: Japan
facility: Research facility ID ORG-000211
city: Hokkaido
country: Japan
facility: Site reference ID/Investigator# 84575
city: Hokkaido
country: Japan
facility: Research facility ORG-000140
city: Hyogo
country: Japan
facility: Research facility ORG-000142
city: Hyogo
country: Japan
facility: Research facility ID ORG-000225
city: Hyogo
country: Japan
facility: Research facility ORG-000159
city: Hyogo
country: Japan
facility: Research facility ORG-000160
city: Hyogo
country: Japan
facility: Research facility ORG-000163
city: Hyogo
country: Japan
facility: Site Reference ID/Investigator# 73816
city: Hyogo
country: Japan
facility: Research facility ORG-000152
city: Ibaraki
country: Japan
facility: Site Reference ID/Investigator# 75804
city: Ibaraki
country: Japan
facility: Research facility ID ORG-000249
city: Ibaraki
country: Japan
facility: Research facility ID ORG-000181
city: Ishikawa
country: Japan
facility: Investigator ID 117498
city: Iwate
country: Japan
facility: Site Reference ID/Investigator# 63982
city: Kagawa
country: Japan
facility: Research facility ID ORG-000260
city: Kagoshima
country: Japan
facility: Research facility ORG-000107
city: Kagoshima
country: Japan
facility: Site reference ID/Investigator# 91860
city: Kagoshima
country: Japan
facility: Research facility ID ORG-000244
city: Kagoshima
country: Japan
facility: Research facility ID ORG-000273
city: Kanagawa
country: Japan
facility: Research facility ID ORG-000212
city: Kanagawa
country: Japan
facility: Research facility ID ORG-000167
city: Kanagawa
country: Japan
facility: Research facility ID ORG-000202
city: Kanagawa
country: Japan
facility: Research faciliity ORG-000099
city: Kanagawa
country: Japan
facility: Research facility ID ORG-000191
city: Kanagawa
country: Japan
facility: Research facility ID ORG-000182
city: Kanagawa
country: Japan
facility: Research facility ID ORG-000255
city: Kanagawa
country: Japan
facility: Research facility ID ORG-000254
city: Kanagawa
country: Japan
facility: Site reference ID/Investigator # 75802
city: Kochi
country: Japan
facility: Research facility ORG-000154
city: Kochi
country: Japan
facility: Research facility ID ORG-000166
city: Kumamoto
country: Japan
facility: Research facility ORG-000113
city: Kyoto
country: Japan
facility: Site reference ID/Investigator # 75789
city: Kyoto
country: Japan
facility: Research facility ORG-000150
city: Kyoto
country: Japan
facility: Research facility ID ORG-000176
city: Kyoto
country: Japan
facility: Research facility ORG-000153
city: Kyoto
country: Japan
facility: Research faclity ORG-000112
city: Kyoto
country: Japan
facility: Research facility ID ORG-000180
city: Kyoto
country: Japan
facility: Research facility ID ORG-000196
city: Kyoto
country: Japan
facility: Investigator ID 117503
city: Kyoto
country: Japan
facility: Research facility ID ORG-000194
city: Mie
country: Japan
facility: Research facility ID ORG-000237
city: Mie
country: Japan
facility: Research facility ORG-000105
city: Miyagi
country: Japan
facility: Research facility ORG-000147
city: Miyagi
country: Japan
facility: Research facility ORG-000092
city: Miyagi
country: Japan
facility: Research facility ORG-000093
city: Miyagi
country: Japan
facility: Site reference ID/Investigator # 84561
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 84560
city: Miyazaki
country: Japan
facility: Investigator ID 117508
city: Miyazaki
country: Japan
facility: Investigator ID 117507
city: Nagano
country: Japan
facility: Site reference ID/Investigator# 96736
city: Nagano
country: Japan
facility: Research facility ORG-000171
city: Nagano
country: Japan
facility: Research facility ID ORG-000290
city: Nagano
country: Japan
facility: Research facility ORG-000109
city: Nagano
country: Japan
facility: Research facility ORG-000115
city: Nagasaki
country: Japan
facility: Research facility ORG-000137
city: Nara
country: Japan
facility: Site reference ID/Investigator # 71102
city: Nara
country: Japan
facility: Research facility ID ORG-000265
city: Niigata
country: Japan
facility: Research facility ORG-000100
city: Niigata
country: Japan
facility: Research facility ORG-000102
city: Niigata
country: Japan
facility: Research facility ORG-000267
city: Niigata
country: Japan
facility: Research facility ID ORG-000193
city: Oita
country: Japan
facility: Research facility ORG-000106
city: Oita
country: Japan
facility: Investigator ID 117497
city: Okayama
country: Japan
facility: Site reference ID/Investigator # 91836
city: Okayama
country: Japan
facility: Research facility ORG-000268
city: Okayama
country: Japan
facility: Research facility ID ORG-000231
city: Okinawa
country: Japan
facility: Site reference ID/Investigator # 91856
city: Osaka
country: Japan
facility: Site Reference ID/Investigator# 86894
city: Osaka
country: Japan
facility: Research facility ORG-000117
city: Osaka
country: Japan
facility: Research facility ORG-000095
city: Osaka
country: Japan
facility: Research facility ID ORG-000183
city: Osaka
country: Japan
facility: Research facility ORG-000089
city: Osaka
country: Japan
facility: Research facility ORG-000090
city: Saga
country: Japan
facility: Research facility ID ORG-000204
city: Saitama
country: Japan
facility: Research facility ORG-000157
city: Saitama
country: Japan
facility: Research facility ORG-000143
city: Saitama
country: Japan
facility: Research facility ID ORG-000189
city: Saitama
country: Japan
facility: Research facility ORG-000135
city: Saitama
country: Japan
facility: Research facility ID ORG-000190
city: Saitama
country: Japan
facility: Research facility ID ORG-000173
city: Saitama
country: Japan
facility: Research facility ID ORG-000199
city: Saitama
country: Japan
facility: Site Reference ID/Investigator# 86895
city: Saitama
country: Japan
facility: Research facility ORG-000172
city: Saitama
country: Japan
facility: Site reference ID/Investigator# 96739
city: Shiga
country: Japan
facility: Research facility ORG-000116
city: Shimane
country: Japan
facility: Research facility ID ORG-000178
city: Shizuoka
country: Japan
facility: Research facility ID ORG-000253
city: Shizuoka
country: Japan
facility: Research facility ID ORG-000252
city: Shizuoka
country: Japan
facility: Site Reference ID/Investigator# 91834
city: Shizuoka
country: Japan
facility: Site reference ID/Investigator# 84576
city: Shizuoka
country: Japan
facility: Research facility ID ORG-000239
city: Tochigi
country: Japan
facility: Research facility ORG-000126
city: Tochigi
country: Japan
facility: Research facility ORG-000108
city: Tokyo
country: Japan
facility: Research facility ORG-000146
city: Tokyo
country: Japan
facility: Research facility ORG-000124
city: Tokyo
country: Japan
facility: Research facility ORG-000132
city: Tokyo
country: Japan
facility: Research facility ORG-000121
city: Tokyo
country: Japan
facility: Research facility ORG-000164
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 84578
city: Tokyo
country: Japan
facility: Investigator ID 117499
city: Tokyo
country: Japan
facility: Research facility ORG-000110
city: Tokyo
country: Japan
facility: Research facility ORG-000101
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 73824
city: Tokyo
country: Japan
facility: Investigator ID 117504
city: Tokyo
country: Japan
facility: Investigator ID 117505
city: Tokyo
country: Japan
facility: Research facility ID ORG-000179
city: Tokyo
country: Japan
facility: Research facility ORG-000138
city: Tokyo
country: Japan
facility: Research facility ID ORG-000195
city: Tokyo
country: Japan
facility: Research facility ORG-000161
city: Tokyo
country: Japan
facility: Research facility ORG-000123
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 75777
city: Tokyo
country: Japan
facility: Research facility ID ORG-000227
city: Tokyo
country: Japan
facility: Research facility ORG-000158
city: Tokyo
country: Japan
facility: Research facility ORG-000103
city: Tokyo
country: Japan
facility: Investigator ID 117501
city: Tokyo
country: Japan
facility: Research facility ORG-000151
city: Tottori
country: Japan
facility: Site reference ID/Investigator # 86913
city: Wakayama
country: Japan
facility: Research facility ID ORG-000243
city: Yamagata
country: Japan
facility: Research facility ORG-000122
city: Yamaguchi
country: Japan
facility: Research facility ID ORG-000263
city: Yamaguchi
country: Japan
facility: Research facility ORG-000128
city: Yamaguchi
country: Japan
facility: Research facility ID ORG-000266
city: Yamanashi
country: Japan
facility: Research facility ORG-000127
Study officials:
affiliation: Abbott Japan Co.,Ltd
name: Jun Kato, MD.,Ph.D.
role: STUDY_DIRECTOR
References: