Skip to main content
OpenTrials
Completed

NCT Number: NCT01427725

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Exocrine Pancreatic Insufficiency Digestive System Diseases Pancreatic Diseases

Age range

1 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research facility ID ORG-000208, Aichi, Japan

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lipacreon

Drug

This study was an observational study and no intervention was specified

Primary outcomes

  1. 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).

    • 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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)

  9. 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

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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)

  21. 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)

  22. 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)

  23. 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)

  24. 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)

Sponsors and collaborators

Lead sponsor

Mylan Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 2, 2011
Registry last updated
Jun 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.