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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Exocrine Pancreatic Insufficiency, Pancreatic Diseases, Digestive System Diseases

Intervention / Treatment
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* Drug: Lipacreon


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lipacreon<br>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<br>* This study was an observational study and no intervention was specified<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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) | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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) | 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) | 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) | 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) | 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) | Baseline, 4 weeks, 8 weeks, 24 weeks, and 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digestive System Diseases, Therapeutic Uses, Pancreatectomy, Gastrointestinal Agents, Pancreatic Diseases, Pancrelipase, Exocrine Pancreatic Insufficiency