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

March 9, 2022 updated by: Mylan Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

579

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 99 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Lipacreon
This study was an observational study and no intervention was specified

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of General Improvement
Time Frame: At week 24

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
At week 24
Degree of General Improvement
Time Frame: At week 52

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
At week 52
Nutritional Endpoints - BMI
Time Frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks

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
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

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
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

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
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

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
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

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.
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

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)
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

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
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

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
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

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.
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

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.
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

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.
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

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.
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

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.
Baseline, 8 weeks, 24 weeks, and 52 weeks
Patient's Quality of Life - Vitality
Time Frame: Baseline, 8 weeks, 24 weeks, and 52 weeks

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.
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

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.
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

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.
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

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.
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

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)
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

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)
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

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)
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

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)
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

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)
Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mylan Inc.

Investigators

  • Study Director: Jun Kato, MD.,Ph.D., Abbott Japan Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

August 31, 2011

First Submitted That Met QC Criteria

August 31, 2011

First Posted (Estimate)

September 2, 2011

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P12-894

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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