Exocrine Pancreatic InsufficiencyNCT01427725
Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency
An observational study of Exocrine Pancreatic Insufficiency and Pancreatic Diseases, run by Mylan Inc. at 189 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 99 years
- Conditions the study is for
- Exocrine Pancreatic Insufficiency, Pancreatic Diseases, Digestive System Diseases
- What is being tested?
- Lipacreon
- Type of treatment
- Pill or oral medicine
- How many people
- 579 participants
- Where
- 189 sitesJapan
- Study dates
- Sep 2011to Apr 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency
Who may be able to join
- Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency
Who cannot join
- Patients with a history of hypersensitivity to the ingredient of LipaCreon.
- Patients with a history of hypersensitivity to porcine protein.
Trial locations and contacts
189 sites in 1 country.
189 sites in 1 country
Japan189 sites
Research facility ID ORG-000247
Aichi, 440-0014
Research facility ID ORG-000216
Aichi, 444-8553
Research facility ID ORG-000214
Aichi, 448-8505
Research facility ID ORG-000215
Aichi, 448-8505
Research facility ORG-000096
Aichi, 451-0052
Research facility ORG-000086
Aichi, 453-0016
Research facility ORG-000120
Aichi, 457-0046
Research facility ORG-000119
Aichi, 460-0001
Research facility ID ORG-000208
Aichi, 460-0004
Site reference ID/Investigator # 75775
Aichi, 467-860
Research facility ID ORG-000256
Aichi, 488-0004
Site Reference ID/Investigator# 68371
Akita, 010-0933
Site Reference ID/Investigator# 71098
Akita, 011-0948
Research facility ORG-000222
Akita, 018-5201
Research facility ORG-000129
Aomori, 036-8171
Research facility ORG-000133
Aomori, 037-0063
Site Reference ID/Investigator# 68378
Chiba, 261-0005
Site Reference ID/Investigator# 75790
Chiba, 262-8506
Research facility ORG-000162
Chiba, 270-0114
site REference ID/Investigator# 75798
Chiba, 275-0026
Research facility ID ORG-000246
Chiba, 278-0005
Site reference ID/Investigator# 88676
Chiba, 278-8501
Research facility ORG-000118
Chiba, 285-8765
Research facility ID ORG-000251
Ehime, 790-0067
Research facility ID ORG-000232
Ehime, 790-8524
Research facility ORG-000233
Ehime, 790-8524
Research facility ORG-000130
Ehime, 799-0193
Research facility ID ORG-000271
Fukui, 910-1193
Site reference ID/Investigator # 88674
Fukui, 918-8503
Research facility ORG-000094
Fukuoka, 800-0257
Research facility ID ORG-000269
Fukuoka, 801-0864
Investigator ID 117496
Fukuoka, 802-0077
Research facility ID ORG-000229
Fukuoka, 803-0186
Research facility ORG-000088
Fukuoka, 810-0041
Research facility ORG-000098
Fukuoka, 811-1347
Research facility ORG-000104
Fukuoka, 812-8582
Research facility ORG-000091
Fukuoka, 814-0001
Research facility ORG-000165
Fukuoka, 816-0864
Research facility ID ORG-000262
Fukuoka, 830-0011
Research facility ORG-000114
Fukuoka, 832-0077
Site Reference ID/Investigator# 84554
Fukushima, 771-1603
Research facility ID ORG-000207
Fukushima, 960-1295
Research facility ORG-000136
Fukushima, 963-3401
Research facility ID ORG-000177
Fukushima, 963-8563
Research facility ID ORG-000238
Gifu, 500-8513
Site reference ID/Investigator# 91833
Gifu, 509-5193
Research facility ORG-000139
Gunma, 371-8511
Research facility ID ORG-000272
Gunma, 373-8585
Site reference ID/Investigator # 84557
Gunma, 379-2311
Research facility ORG-000156
Hiroshima, 722-8508
Research facility ID ORG-000241
Hiroshima, 730-0847
Research facility ID ORG-000203
Hiroshima, 731-5116
Site reference ID/Investigator # 91835
Hiroshima, 732-0046
Site Reference ID/Investigator# 88698
Hiroshima, 736-0082
Site Reference ID/Investigator# 84515
Hiroshima, 737-0193
Research facility ORG-000155
Hiroshima, 739-1732
Research facility ID ORG-000213
Hokkaido, 001-0033
Research facility ORG-000097
Hokkaido, 003-0006
Research facility ID ORG-000220
Hokkaido, 006-0811
Research facility ID/Investigator # ORG-000221 / 86896
Hokkaido, 006-0811
Site Reference ID/Investigator# 84535
Hokkaido, 006-0832
Research facility ID ORG-000250
Hokkaido, 047-8550
Site Reference ID# 84573
Hokkaido, 053-8567
Research facility ID ORG-000223
Hokkaido, 060-0033
Research facility ID ORG-000201
Hokkaido, 060-8543
Research facility ID ORG-000211
Hokkaido, 060-8648
Site reference ID/Investigator# 84575
Hokkaido, 085-0822
Research facility ORG-000140
Hokkaido, 098-5551
Research facility ORG-000142
Hyōgo, 650-0017
Research facility ID ORG-000225
Hyōgo, 665-0881
Research facility ORG-000159
Hyōgo, 669-2721
Research facility ORG-000160
Hyōgo, 669-3301
Research facility ORG-000163
Hyōgo, 671-1122
Site Reference ID/Investigator# 73816
Hyōgo, 674-0061
Research facility ORG-000152
Hyōgo, 679-4122
Site Reference ID/Investigator# 75804
Ibaraki, 300-0047
Research facility ID ORG-000249
Ibaraki, 311-4151
Research facility ID ORG-000181
Ibaraki, 313-0062
Investigator ID 117498
Ishikawa, 920-0265
Research facility ID ORG-000260
Kagawa, 760-8557
Research facility ORG-000107
Kagoshima, 891-0143
Site reference ID/Investigator# 91860
Kagoshima, 897-0031
Research facility ID ORG-000244
Kagoshima, 899-5112
Research facility ID ORG-000273
Kagoshima, 899-5215
Research facility ID ORG-000212
Kanagawa, 216-8511
Research facility ID ORG-000167
Kanagawa, 221-0832
Research facility ID ORG-000202
Kanagawa, 224-8503
Research faciliity ORG-000099
Kanagawa, 236-0004
Research facility ID ORG-000191
Kanagawa, 239-0831
Research facility ID ORG-000182
Kanagawa, 244-0817
Research facility ID ORG-000255
Kanagawa, 252-0380
Research facility ID ORG-000254
Kanagawa, 252-0816
Site reference ID/Investigator # 75802
Kanagawa, 256-0816
Research facility ORG-000154
Kochi, 780-0041
Research facility ID ORG-000166
Kochi, 780-8077
Research facility ORG-000113
Kumamoto, 865-0005
Site reference ID/Investigator # 75789
Kyoto, 600-8558
Research facility ORG-000150
Kyoto, 602-8599
Research facility ID ORG-000176
Kyoto, 603-8156
Research facility ORG-000153
Kyoto, 606-8203
Research faclity ORG-000112
Kyoto, 606-8507
Research facility ID ORG-000180
Kyoto, 612-8065
Research facility ID ORG-000196
Kyoto, 615-0003
Investigator ID 117503
Kyoto, 623-0011
Research facility ID ORG-000194
Kyoto, 624-0914
Research facility ID ORG-000237
Mie, 510-0016
Research facility ORG-000105
Mie, 514-8507
Research facility ORG-000147
Miyagi, 980-0004
Research facility ORG-000092
Miyagi, 980-0872
Research facility ORG-000093
Miyagi, 980-0872
Site reference ID/Investigator # 84561
Miyagi, 983-8512
Site Reference ID/Investigator# 84560
Miyagi, 983-8512
Investigator ID 117508
Miyazaki, 885-0023
Investigator ID 117507
Miyazaki, 885-0083
Site reference ID/Investigator# 96736
Nagano, 383-8505
Research facility ORG-000171
Nagano, 384-8588
Research facility ID ORG-000290
Nagano, 390-0848
Research facility ORG-000109
Nagano, 390-8505
Research facility ORG-000115
Nagano, 396-0025
Research facility ORG-000137
Nagasaki, 857-0055
Site reference ID/Investigator # 71102
Nara, 636-0802
Research facility ID ORG-000265
Nara, 638-8521
Research facility ORG-000100
Niigata, 942-0061
Research facility ORG-000102
Niigata, 945-0047
Research facility ORG-000267
Niigata, 957-0067
Research facility ID ORG-000193
Niigata, 958-8533
Site Reference ID/Investigator# 63982
Numakunai, 024-0004
Research facility ORG-000106
Ōita, 870-0036
Investigator ID 117497
Ōita, 870-0924
Site reference ID/Investigator # 91836
Okayama, 700-8530
Research facility ORG-000268
Okayama, 710-0816
Research facility ID ORG-000231
Okayama, 719-3193
Site reference ID/Investigator # 91856
Okinawa, 904-2195
Site Reference ID/Investigator# 86894
Osaka, 537-8511
Research facility ORG-000117
Osaka, 540-0006
Research facility ORG-000095
Osaka, 567-0035
Research facility ID ORG-000183
Osaka, 573-1191
Research facility ORG-000089
Osaka, 589-0014
Research facility ORG-000090
Osaka, 589-0014
Research facility ID ORG-000204
Saga, 849-0916
Research facility ORG-000157
Saitama, 331-0054
Research facility ORG-000143
Saitama, 335-0035
Research facility ID ORG-000189
Saitama, 345-0834
Research facility ORG-000135
Saitama, 348-0053
Research facility ID ORG-000190
Saitama, 349-0217
Research facility ID ORG-000173
Saitama, 350-0018
Research facility ID ORG-000199
Saitama, 350-1123
Site Reference ID/Investigator# 86895
Saitama, 350-8550
Research facility ORG-000172
Saitama, 358-0023
Site reference ID/Investigator# 96739
Saitama, 359-1141
Research facility ORG-000116
Shiga, 525-0066
Research facility ID ORG-000178
Shimane, 693-8501
Research facility ID ORG-000253
Shizuoka, 410-2295
Research facility ID ORG-000252
Shizuoka, 426-0072
Site Reference ID/Investigator# 91834
Shizuoka, 431-3192
Site reference ID/Investigator# 84576
Shizuoka, 438-0085
Research facility ID ORG-000239
Shizuoka, 439-0022
Research facility ORG-000126
Tochigi, 329-0214
Research facility ORG-000108
Tochigi, 329-2722
Research facility ORG-000146
Tokyo, 105-0004
Research facility ORG-000124
Tokyo, 113-8655
Research facility ORG-000132
Tokyo, 113-8655
Research facility ORG-000121
Tokyo, 116-0003
Research facility ORG-000164
Tokyo, 132-0033
Site Reference ID/Investigator# 84578
Tokyo, 135-0002
Investigator ID 117499
Tokyo, 143-0013
Research facility ORG-000110
Tokyo, 143-8541
Research facility ORG-000101
Tokyo, 150-8935
Site Reference ID/Investigator# 73824
Tokyo, 152-0002
Investigator ID 117504
Tokyo, 160-0016
Investigator ID 117505
Tokyo, 160-0016
Research facility ID ORG-000179
Tokyo, 162-0055
Research facility ORG-000138
Tokyo, 162-8666
Research facility ID ORG-000195
Tokyo, 168-0082
Research facility ORG-000161
Tokyo, 170-0013
Research facility ORG-000123
Tokyo, 173-0004
Site Reference ID/Investigator# 75777
Tokyo, 173-8606
Research facility ID ORG-000227
Tokyo, 178-0064
Research facility ORG-000158
Tokyo, 190-0014
Research facility ORG-000103
Tokyo, 192-0046
Investigator ID 117501
Tokyo, 194-0023
Research facility ORG-000151
Tokyo, 194-0023
Site reference ID/Investigator # 86913
Tottori, 683-0006
Research facility ID ORG-000243
Wakayama, 641-8509
Research facility ORG-000122
Yamagata, 990-0027
Research facility ID ORG-000263
Yamaguchi, 742-0032
Research facility ORG-000128
Yamaguchi, 745-8522
Research facility ID ORG-000266
Yamaguchi, 755-0049
Research facility ORG-000127
Yamanashi, 409-3898
About this study
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
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.
Read the detailed description
Criteria for evaluation:
- Adverse events
- Nutritional endpoints
- BMI (height [only prior to the start of Lipacreon treatment] and weight)
- Serum total protein
- Albumin
- Total cholesterol
- Triglycerides
- Haemoglobin
- Symptoms related to exocrine pancreatic insufficiency
- Steatorrhoea
- Frequency of bowel movements
- Diarrhoea
- Foul stool odour
- Decreased appetite
- Abdominal distension
- Patient's quality of life (QOL)
- Degree of general improvement
- Being tested
- Lipacreon
- Keywords
- Digestive System Diseases, Therapeutic Uses, Pancreatectomy, Gastrointestinal Agents, Pancreatic Diseases, Pancrelipase, Exocrine Pancreatic Insufficiency
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Pancreatic Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipacreonDrug
This study was an observational study and no intervention was specified
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lipacreon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
- 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.
- 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
Measured: At week 52
Secondary outcomes (24)
Degree of General Improvement
It was assessed at 24 weeks after the start of Lipacreon treatment and at the end of the observation period, using the following 4 grades:
Improved, unchanged, exacerbated, unassessable
Measured: At week 24
Degree of General Improvement
It was assessed at 24 weeks after the start of Lipacreon treatment and at the end of the observation period, using the following 4 grades:
Improved, unchanged, exacerbated, unassessable
Measured: At week 52
Nutritional Endpoints - BMI
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.
- BMI (height [only prior to the start of Lipacreon treatment] and weight)
- Serum total protein
- Albumin
- Total cholesterol
- Triglycerides
- Haemoglobin
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Nutritional Endpoints - Serum Total Protein
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.
- BMI (height [only prior to the start of Lipacreon treatment] and weight)
- Serum total protein
- Albumin
- Total cholesterol
- Triglycerides
- Haemoglobin
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Nutrition Endpoints - Albumin
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.
- BMI (height [only prior to the start of Lipacreon treatment] and weight)
- Serum total protein
- Albumin
- Total cholesterol
- Triglycerides
- Haemoglobin
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Nutrition Endpoints - Total Cholesterol
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.
- BMI (height [only prior to the start of Lipacreon treatment] and weight)
- Serum total protein
- Albumin
- Total cholesterol
- Triglycerides
- Haemoglobin
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Physical Health (Summary)
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.
Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.
PCS8 score is calculated by the following formula (All summed). PCS8 score = (0.23024×SF8GH)+(0.40672×SF8PF)+(0.38317×SF8RP)+(0.33295×SF8BP)+(0.07537×SF8VT)+(-0.01275×SF8SF)+(-0.30469×SF8MH)+(-0.14803×SF8RE)+0.67371
The minimum value of PCS8 is 5.315, and the maximum value is 70.689. Higher scores mean a better outcome.
The means ± SD was calculated by summing the values at each time point.
Measured: Baseline, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.
- Steatorrhoea (Yes/No)
- Frequency of bowel movements (times/day)
- Diarrhoea (Yes/No)
- Foul stool odour (Yes/No)
- Decreased appetite (Yes/No)
- Abdominal distension (Yes/No)
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Nutrition Endpoints - Triglycerides
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.
- BMI (height [only prior to the start of Lipacreon treatment] and weight)
- Serum total protein
- Albumin
- Total cholesterol
- Triglycerides
- Haemoglobin
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Nutrition Endpoints - Haemoglobin
The following nutritional endpoints were measured prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.
- BMI (height [only prior to the start of Lipacreon treatment] and weight)
- Serum total protein
- Albumin
- Total cholesterol
- Triglycerides
- Haemoglobin
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Mental Health (Summary)
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.
Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.
MCS8 score is calculated by the following formula (All summed). MCS8 score = (-0.02020×SF8GH)+(-0.19972×SF8PF)+(-0.16579×SF8RP)+(-0.15992×SF8BP)+(0.16737×SF8VT)+(0.27264×SF8SF)+(0.57583×SF8MH)+(0.42927×SF8RE)+4.34744
The minimum value of MCS8 is 10.108, and the maximum value is 74.511. Higher scores mean a better outcome.
The means ± SD was calculated by summing the values at each time point.
Measured: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - General Health
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.
Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.
SF8GH scores; 1:63.38, 2:58.54, 3:50.27, 4:40.40, 5:34.38, 6:26.89 The minimum value of SF8GH is 26.89, and the maximum value is 63.38. Higher scores mean a better outcome.
The means ± SD was calculated by summing the values at each time point.
Measured: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Physical Functioning
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.
Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.
SF8PF scores; 1:53.54, 2:47.77, 3:41.45, 4:27.59, 5:16.69 The minimum value of SF8PF is 16.69, and the maximum value is 53.54. Higher scores mean a better outcome.
The means ± SD was calculated by summing the values at each time point.
Measured: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Role Physical
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.
Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.
SF8RP scores; 1:54.09, 2:47.42, 3:40.65, 4:27.91, 5:21.80. The minimum value of SF8RP is 21.80, and the maximum value is 54.09. Higher scores mean a better outcome.
The means ± SD was calculated by summing the values at each time point.
Measured: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Body Pain
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.
Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.
SF8BP scores; 1:60.35, 2:52.46, 3:46.10, 4:38.21, 5:31.59, 6:21.68. The minimum value of SF8BP is 21.68, and the maximum value is 60.35. Higher scores mean a better outcome.
The means ± SD was calculated by summing the values at each time point.
Measured: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Vitality
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.
Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.
SF8VT scores; 1:60.01, 2:53.74, 3:44.48, 4:38.51, 5:28.68. The minimum value of SF8VT is 28.68, and the maximum value is 60.01. Higher scores mean a better outcome.
The means ± SD was calculated by summing the values at each time point.
Measured: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Social Functioning
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.
Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.
SF8SF scores; 1:55.14, 2:45.60, 3:37.65, 4:29.15, 5:26.00. The minimum value of SF8SF is 26.00, and the maximum value is 55.14. Higher scores mean a better outcome.
The means ± SD was calculated by summing the values at each time point.
Measured: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Mental Health
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.
Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.
SF8MH scores; 1:56.93, 2:50.72, 3:44.94, 4:36.30, 5:27.59. The minimum value of SF8MH is 27.59, and the maximum value is 56.93. Higher scores mean a better outcome.
The means ± SD was calculated by summing the values at each time point.
Measured: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Role Emotional
Baseline, 8 and 24 weeks after the start of treatment, and at the end of the observation period, the patient was asked to fill out the standard SF-8™ (1 month) to assess the patient's QOL, which was recorded in the survey form for this survey. SF-8™:The Medical Outcomes Study 8-Item Short-Form Health Survey (Japanese version). Items are as follows.
Physical health (summary):PCS8, Mental health (summary):MCS8, General health:SF8GH, Physical functioning:SF8PF, Role physical:SF8RP, Body pain:SF8BP, Vitality:SF8VT, Social functioning:SF8SF, Mental health:SF8MH, Role emotional:SF8RE.
SF8RE scores; 1:54.19, 2:48.04, 3:42.24, 4:31.42, 5:19.98. The minimum value of SF8RE is 19.98, and the maximum value is 54.19. Higher scores mean a better outcome.
The means ± SD was calculated by summing the values at each time point.
Measured: Baseline, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.
- Steatorrhoea (Yes/No)
- Frequency of bowel movements (times/day)
- Diarrhoea (Yes/No)
- Foul stool odour (Yes/No)
- Decreased appetite (Yes/No)
- Abdominal distension (Yes/No)
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.
- Steatorrhoea (Yes/No)
- Frequency of bowel movements (times/day)
- Diarrhoea (Yes/No)
- Foul stool odour (Yes/No)
- Decreased appetite (Yes/No)
- Abdominal distension (Yes/No)
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.
- Steatorrhoea (Yes/No)
- Frequency of bowel movements (times/day)
- Diarrhoea (Yes/No)
- Foul stool odour (Yes/No)
- Decreased appetite (Yes/No)
- Abdominal distension (Yes/No)
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.
- Steatorrhoea (Yes/No)
- Frequency of bowel movements (times/day)
- Diarrhoea (Yes/No)
- Foul stool odour (Yes/No)
- Decreased appetite (Yes/No)
- Abdominal distension (Yes/No)
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension
The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, 4, 8 and 24 weeks after the start of treatment, and at the end of the observation period.
- Steatorrhoea (Yes/No)
- Frequency of bowel movements (times/day)
- Diarrhoea (Yes/No)
- Foul stool odour (Yes/No)
- Decreased appetite (Yes/No)
- Abdominal distension (Yes/No)
Measured: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Exocrine Pancreatic InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Kato, MD.,Ph.D., Study director, Abbott Japan Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427725
- Sponsor's protocol ID
- P12-894
- Status last verified
- Mar 2022
- First submitted
- 31 Aug 2011
- Last updated
- 13 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01427725
- Acronym / sponsor ID
- P12-894
- Keywords
- Digestive System Diseases, Therapeutic Uses, Pancreatectomy, Gastrointestinal Agents, Pancreatic Diseases, Pancrelipase, Exocrine Pancreatic Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- Mylan Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 2 Sep 2011 (estimated)
- Results
- Posted 13 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Adverse events
- Nutritional endpoints
- BMI (height [only prior to the start of Lipacreon treatment] and weight)
- Serum total protein
- Albumin
- Total cholesterol
- Triglycerides
- Haemoglobin
- Symptoms related to exocrine pancreatic insufficiency
- Steatorrhoea
- Frequency of bowel movements
- Diarrhoea
- Foul stool odour
- Decreased appetite
- Abdominal distension
- Patient's quality of life (QOL)
- Degree of general improvement
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lipacreon | – | Drug: LipacreonIn 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. |
Who may qualify
- Ages
- 1 year to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency
Key inclusion criteria (1 listed)
- Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency
Key exclusion criteria (2 listed)
- Patients with a history of hypersensitivity to the ingredient of LipaCreon.
- Patients with a history of hypersensitivity to porcine protein.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LipacreonThis study was an observational study and no intervention was specified | Drug | Lipacreon |
Primary outcome
Number of Patients With Adverse Drug Reaction
Time frame: At week 52
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
24 secondary outcomes
Degree of General Improvement
Time frame: At week 24
Degree of General Improvement
Time frame: At week 52
Nutritional Endpoints - BMI
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Nutritional Endpoints - Serum Total Protein
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Nutrition Endpoints - Albumin
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Nutrition Endpoints - Total Cholesterol
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Physical Health (Summary)
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Nutrition Endpoints - Triglycerides
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Nutrition Endpoints - Haemoglobin
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Mental Health (Summary)
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - General Health
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Physical Functioning
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Role Physical
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Body Pain
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Vitality
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Social Functioning
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Mental Health
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Role Emotional
Time frame: Baseline, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
Related trials for Exocrine Pancreatic Insufficiency
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingPhase 2
Phase 2 Study to Assess the Safety and Efficacy of ANG003
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
RecruitingObservational study
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
Exocrine Pancreatic Insuficiency
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Kato, MD.,Ph.D. study director
Abbott Japan Co.,Ltd
189 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exocrine Pancreatic Insufficiency and Pancreatic Diseases, run by Mylan Inc. at 189 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 189 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Adverse Drug Reaction (time frame: At week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.