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.
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
579
This study was an observational study and no intervention was specified
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). 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
Time frame: At week 52
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
Time frame: 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
Time frame: 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
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks
Nutritional Endpoints - Serum Total Protein
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Research facility ID ORG-000247
Aichi, Japan
Research facility ID ORG-000216
Aichi, Japan
Research facility ID ORG-000214
Aichi, Japan
Research facility ID ORG-000215
Aichi, Japan
Research facility ORG-000096
Aichi, Japan
Research facility ORG-000086
Aichi, Japan
Research facility ORG-000120
Aichi, Japan
Research facility ORG-000119
Aichi, Japan
Research facility ID ORG-000208
Aichi, Japan
Site reference ID/Investigator # 75775
Aichi, Japan
...and 179 more locations
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks