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Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency

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ClinicalTrials.gov Identifier: NCT01427725
Recruitment Status : Completed
First Posted : September 2, 2011
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Mylan Inc.

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.

Condition or disease
Exocrine Pancreatic Insufficiency Pancreatic Diseases Digestive System Diseases

Study Type : Observational
Actual Enrollment : 562 participants
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
Study Start Date : October 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Group/Cohort
LipaCreon
those with an exposure



Primary Outcome Measures :
  1. 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.

  2. Nutrition assessment items [ Time Frame: At week 52 ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin


Secondary Outcome Measures :
  1. Overall improvement rating [ Time Frame: At week 24 ]
    Four grades: Effective, unchanged, aggravation, unassessable

  2. Overall improvement rating [ Time Frame: At week 52 ]
    Four grades: Effective, unchanged, aggravation, unassessable

  3. Nutrition assessment items [ Time Frame: Baseline ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

  4. Nutrition assessment items [ Time Frame: At week 4 ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

  5. Nutrition assessment items [ Time Frame: At week 8 ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

  6. Nutrition assessment items [ Time Frame: At week 24 ]
    Body Mass Index, Serum total protein, Albumin, Total cholesterol, Triglyceride, Hemoglobin

  7. Health Related Quality of Life [ Time Frame: Baseline ]
    SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)

  8. Health Related Quality of Life [ Time Frame: at week 8 ]
    SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)

  9. Health Related Quality of Life [ Time Frame: at week 24 ]
    SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)

  10. Health Related Quality of Life [ Time Frame: at week 52 ]
    SF-8™ (The Medical Outcomes Study 8-Item Short-Form Health Survey) (Japanese version)

  11. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: Baseline ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

  12. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 4 ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

  13. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 8 ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

  14. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 24 ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention

  15. Symptoms relating to pancreatic exocrine insufficiency [ Time Frame: At week 52 ]
    Steatorrhea, Frequency of defecation, Diarrhea, Bad odor of feces, Appetite loss, Abdominal distention



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Ages Eligible for Study:   Child, Adult, Older Adult
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427725


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Locations
Japan
Research facility ID ORG-000247
Aichi, Japan, 440-0014
Research facility ID ORG-000216
Aichi, Japan, 444-8553
Research facility ID ORG-000214
Aichi, Japan, 448-8505
Research facility ID ORG-000215
Aichi, Japan, 448-8505
Research facility ORG-000096
Aichi, Japan, 451-0052
Research facility ORG-000086
Aichi, Japan, 453-0016
Research facility ORG-000120
Aichi, Japan, 457-0046
Research facility ORG-000119
Aichi, Japan, 460-0001
Research facility ID ORG-000208
Aichi, Japan, 460-0004
Site reference ID/Investigator # 75775
Aichi, Japan, 467-860
Research facility ID ORG-000256
Aichi, Japan, 488-0004
Site Reference ID/Investigator# 68371
Akita, Japan, 010-0933
Site Reference ID/Investigator# 71098
Akita, Japan, 011-0948
Research facility ORG-000222
Akita, Japan, 018-5201
Research facility ORG-000129
Aomori, Japan, 036-8171
Research facility ORG-000133
Aomori, Japan, 037-0063
Site Reference ID/Investigator# 68378
Chiba, Japan, 261-0005
Site Reference ID/Investigator# 75790
Chiba, Japan, 262-8506
Research facility ORG-000162
Chiba, Japan, 270-0114
site REference ID/Investigator# 75798
Chiba, Japan, 275-0026
Research facility ID ORG-000246
Chiba, Japan, 278-0005
Site reference ID/Investigator# 88676
Chiba, Japan, 278-8501
Research facility ORG-000118
Chiba, Japan, 285-8765
Research facility ID ORG-000251
Ehime, Japan, 790-0067
Research facility ID ORG-000232
Ehime, Japan, 790-8524
Research facility ORG-000233
Ehime, Japan, 790-8524
Research facility ORG-000130
Ehime, Japan, 799-0193
Research facility ID ORG-000271
Fukui, Japan, 910-1193
Site reference ID/Investigator # 88674
Fukui, Japan, 918-8503
Research facility ORG-000094
Fukuoka, Japan, 800-0257
Research facility ID ORG-000269
Fukuoka, Japan, 801-0864
Investigator ID 117496
Fukuoka, Japan, 802-0077
Research facility ID ORG-000229
Fukuoka, Japan, 803-0186
Research facility ORG-000088
Fukuoka, Japan, 810-0041
Research facility ORG-000098
Fukuoka, Japan, 811-1347
Research facility ORG-000104
Fukuoka, Japan, 812-8582
Research facility ORG-000091
Fukuoka, Japan, 814-0001
Research facility ORG-000165
Fukuoka, Japan, 816-0864
Research facility ID ORG-000262
Fukuoka, Japan, 830-0011
Research facility ORG-000114
Fukuoka, Japan, 832-0077
Site Reference ID/Investigator# 84554
Fukushima, Japan, 771-1603
Research facility ID ORG-000207
Fukushima, Japan, 960-1295
Research facility ORG-000136
Fukushima, Japan, 963-3401
Research facility ID ORG-000177
Fukushima, Japan, 963-8563
Research facility ID ORG-000238
Gifu, Japan, 500-8513
Site reference ID/Investigator# 91833
Gifu, Japan, 509-5193
Research facility ORG-000139
Gunma, Japan, 371-8511
Research facility ID ORG-000272
Gunma, Japan, 373-8585
Site reference ID/Investigator # 84557
Gunma, Japan, 379-2311
Research facility ORG-000156
Hiroshima, Japan, 722-8508
Research facility ID ORG-000241
Hiroshima, Japan, 730-0847
Research facility ID ORG-000203
Hiroshima, Japan, 731-5116
Site reference ID/Investigator # 91835
Hiroshima, Japan, 732-0046
Site Reference ID/Investigator# 88698
Hiroshima, Japan, 736-0082
Site Reference ID/Investigator# 84515
Hiroshima, Japan, 737-0193
Research facility ORG-000155
Hiroshima, Japan, 739-1732
Research facility ID ORG-000213
Hokkaido, Japan, 001-0033
Research facility ORG-000097
Hokkaido, Japan, 003-0006
Research facility ID ORG-000220
Hokkaido, Japan, 006-0811
Research facility ID/Investigator # ORG-000221 / 86896
Hokkaido, Japan, 006-0811
Site Reference ID/Investigator# 84535
Hokkaido, Japan, 006-0832
Research facility ID ORG-000250
Hokkaido, Japan, 047-8550
Site Reference ID# 84573
Hokkaido, Japan, 053-8567
Research facility ID ORG-000223
Hokkaido, Japan, 060-0033
Research facility ID ORG-000201
Hokkaido, Japan, 060-8543
Research facility ID ORG-000211
Hokkaido, Japan, 060-8648
Site reference ID/Investigator# 84575
Hokkaido, Japan, 085-0822
Research facility ORG-000140
Hokkaido, Japan, 098-5551
Research facility ORG-000142
Hyogo, Japan, 650-0017
Research facility ID ORG-000225
Hyogo, Japan, 665-0881
Research facility ORG-000159
Hyogo, Japan, 669-2721
Research facility ORG-000160
Hyogo, Japan, 669-3301
Research facility ORG-000163
Hyogo, Japan, 671-1122
Site Reference ID/Investigator# 73816
Hyogo, Japan, 674-0061
Research facility ORG-000152
Hyogo, Japan, 679-4122
Site Reference ID/Investigator# 75804
Ibaraki, Japan, 300-0047
Research facility ID ORG-000249
Ibaraki, Japan, 311-4151
Research facility ID ORG-000181
Ibaraki, Japan, 313-0062
Investigator ID 117498
Ishikawa, Japan, 920-0265
Site Reference ID/Investigator# 63982
Iwate, Japan, 024-0004
Research facility ID ORG-000260
Kagawa, Japan, 760-8557
Research facility ORG-000107
Kagoshima, Japan, 891-0143
Site reference ID/Investigator# 91860
Kagoshima, Japan, 897-0031
Research facility ID ORG-000244
Kagoshima, Japan, 899-5112
Research facility ID ORG-000273
Kagoshima, Japan, 899-5215
Research facility ID ORG-000212
Kanagawa, Japan, 216-8511
Research facility ID ORG-000167
Kanagawa, Japan, 221-0832
Research facility ID ORG-000202
Kanagawa, Japan, 224-8503
Research faciliity ORG-000099
Kanagawa, Japan, 236-0004
Research facility ID ORG-000191
Kanagawa, Japan, 239-0831
Research facility ID ORG-000182
Kanagawa, Japan, 244-0817
Research facility ID ORG-000255
Kanagawa, Japan, 252-0380
Research facility ID ORG-000254
Kanagawa, Japan, 252-0816
Site reference ID/Investigator # 75802
Kanagawa, Japan, 256-0816
Research facility ORG-000154
Kochi, Japan, 780-0041
Research facility ID ORG-000166
Kochi, Japan, 780-8077
Research facility ORG-000113
Kumamoto, Japan, 865-0005
Site reference ID/Investigator # 75789
Kyoto, Japan, 600-8558
Research facility ORG-000150
Kyoto, Japan, 602-8599
Research facility ID ORG-000176
Kyoto, Japan, 603-8156
Research facility ORG-000153
Kyoto, Japan, 606-8203
Research faclity ORG-000112
Kyoto, Japan, 606-8507
Research facility ID ORG-000180
Kyoto, Japan, 612-8065
Research facility ID ORG-000196
Kyoto, Japan, 615-0003
Investigator ID 117503
Kyoto, Japan, 623-0011
Research facility ID ORG-000194
Kyoto, Japan, 624-0914
Research facility ID ORG-000237
Mie, Japan, 510-0016
Research facility ORG-000105
Mie, Japan, 514-8507
Research facility ORG-000147
Miyagi, Japan, 980-0004
Research facility ORG-000092
Miyagi, Japan, 980-0872
Research facility ORG-000093
Miyagi, Japan, 980-0872
Site reference ID/Investigator # 84561
Miyagi, Japan, 983-8512
Site Reference ID/Investigator# 84560
Miyagi, Japan, 983-8512
Investigator ID 117508
Miyazaki, Japan, 885-0023
Investigator ID 117507
Miyazaki, Japan, 885-0083
Site reference ID/Investigator# 96736
Nagano, Japan, 383-8505
Research facility ORG-000171
Nagano, Japan, 384-8588
Research facility ID ORG-000290
Nagano, Japan, 390-0848
Research facility ORG-000109
Nagano, Japan, 390-8505
Research facility ORG-000115
Nagano, Japan, 396-0025
Research facility ORG-000137
Nagasaki, Japan, 857-0055
Site reference ID/Investigator # 71102
Nara, Japan, 636-0802
Research facility ID ORG-000265
Nara, Japan, 638-8521
Research facility ORG-000100
Niigata, Japan, 942-0061
Research facility ORG-000102
Niigata, Japan, 945-0047
Research facility ORG-000267
Niigata, Japan, 957-0067
Research facility ID ORG-000193
Niigata, Japan, 958-8533
Research facility ORG-000106
Oita, Japan, 870-0036
Investigator ID 117497
Oita, Japan, 870-0924
Site reference ID/Investigator # 91836
Okayama, Japan, 700-8530
Research facility ORG-000268
Okayama, Japan, 710-0816
Research facility ID ORG-000231
Okayama, Japan, 719-3193
Site reference ID/Investigator # 91856
Okinawa, Japan, 904-2195
Site Reference ID/Investigator# 86894
Osaka, Japan, 537-8511
Research facility ORG-000117
Osaka, Japan, 540-0006
Research facility ORG-000095
Osaka, Japan, 567-0035
Research facility ID ORG-000183
Osaka, Japan, 573-1191
Research facility ORG-000089
Osaka, Japan, 589-0014
Research facility ORG-000090
Osaka, Japan, 589-0014
Research facility ID ORG-000204
Saga, Japan, 849-0916
Research facility ORG-000157
Saitama, Japan, 331-0054
Research facility ORG-000143
Saitama, Japan, 335-0035
Research facility ID ORG-000189
Saitama, Japan, 345-0834
Research facility ORG-000135
Saitama, Japan, 348-0053
Research facility ID ORG-000190
Saitama, Japan, 349-0217
Research facility ID ORG-000173
Saitama, Japan, 350-0018
Research facility ID ORG-000199
Saitama, Japan, 350-1123
Site Reference ID/Investigator# 86895
Saitama, Japan, 350-8550
Research facility ORG-000172
Saitama, Japan, 358-0023
Site reference ID/Investigator# 96739
Saitama, Japan, 359-1141
Research facility ORG-000116
Shiga, Japan, 525-0066
Research facility ID ORG-000178
Shimane, Japan, 693-8501
Research facility ID ORG-000253
Shizuoka, Japan, 410-2295
Research facility ID ORG-000252
Shizuoka, Japan, 426-0072
Site Reference ID/Investigator# 91834
Shizuoka, Japan, 431-3192
Site reference ID/Investigator# 84576
Shizuoka, Japan, 438-0085
Research facility ID ORG-000239
Shizuoka, Japan, 439-0022
Research facility ORG-000126
Tochigi, Japan, 329-0214
Research facility ORG-000108
Tochigi, Japan, 329-2722
Research facility ORG-000146
Tokyo, Japan, 105-0004
Research facility ORG-000124
Tokyo, Japan, 113-8655
Research facility ORG-000132
Tokyo, Japan, 113-8655
Research facility ORG-000121
Tokyo, Japan, 116-0003
Research facility ORG-000164
Tokyo, Japan, 132-0033
Site Reference ID/Investigator# 84578
Tokyo, Japan, 135-0002
Investigator ID 117499
Tokyo, Japan, 143-0013
Research facility ORG-000110
Tokyo, Japan, 143-8541
Research facility ORG-000101
Tokyo, Japan, 150-8935
Site Reference ID/Investigator# 73824
Tokyo, Japan, 152-0002
Investigator ID 117504
Tokyo, Japan, 160-0016
Investigator ID 117505
Tokyo, Japan, 160-0016
Research facility ID ORG-000179
Tokyo, Japan, 162-0055
Research facility ORG-000138
Tokyo, Japan, 162-8666
Research facility ID ORG-000195
Tokyo, Japan, 168-0082
Research facility ORG-000161
Tokyo, Japan, 170-0013
Research facility ORG-000123
Tokyo, Japan, 173-0004
Site Reference ID/Investigator# 75777
Tokyo, Japan, 173-8606
Research facility ID ORG-000227
Tokyo, Japan, 178-0064
Research facility ORG-000158
Tokyo, Japan, 190-0014
Research facility ORG-000103
Tokyo, Japan, 192-0046
Investigator ID 117501
Tokyo, Japan, 194-0023
Research facility ORG-000151
Tokyo, Japan, 194-0023
Site reference ID/Investigator # 86913
Tottori, Japan, 683-0006
Research facility ID ORG-000243
Wakayama, Japan, 641-8509
Research facility ORG-000122
Yamagata, Japan, 990-0027
Research facility ID ORG-000263
Yamaguchi, Japan, 742-0032
Research facility ORG-000128
Yamaguchi, Japan, 745-8522
Research facility ID ORG-000266
Yamaguchi, Japan, 755-0049
Research facility ORG-000127
Yamanashi, Japan, 409-3898
Sponsors and Collaborators
Mylan Inc.
Investigators
Study Director: Jun Kato, MD.,Ph.D. Abbott Japan Co.,Ltd

Responsible Party: Mylan Inc.
ClinicalTrials.gov Identifier: NCT01427725     History of Changes
Other Study ID Numbers: P12-894
First Posted: September 2, 2011    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: May 2015

Keywords provided by Mylan Inc.:
Digestive System Diseases
Therapeutic Uses
Pancreatectomy
Gastrointestinal Agents
Pancreatic Diseases
Pancrelipase
Exocrine Pancreatic Insufficiency

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Exocrine Pancreatic Insufficiency
Pancreatic Diseases