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

NCT ID: NCT01427725

Last Updated: 2022-06-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

579 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-04-30

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.

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Detailed Description

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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

Conditions

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Exocrine Pancreatic Insufficiency Pancreatic Diseases Digestive System Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Lipacreon

Intervention Type DRUG

This study was an observational study and no intervention was specified

Interventions

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Lipacreon

This study was an observational study and no intervention was specified

Intervention Type DRUG

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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mylan Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jun Kato, MD.,Ph.D.

Role: STUDY_DIRECTOR

Abbott Japan Co.,Ltd

Locations

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Research facility ID ORG-000247

Aichi, , Japan

Site Status

Research facility ID ORG-000216

Aichi, , Japan

Site Status

Research facility ID ORG-000214

Aichi, , Japan

Site Status

Research facility ID ORG-000215

Aichi, , Japan

Site Status

Research facility ORG-000096

Aichi, , Japan

Site Status

Research facility ORG-000086

Aichi, , Japan

Site Status

Research facility ORG-000120

Aichi, , Japan

Site Status

Research facility ORG-000119

Aichi, , Japan

Site Status

Research facility ID ORG-000208

Aichi, , Japan

Site Status

Site reference ID/Investigator # 75775

Aichi, , Japan

Site Status

Research facility ID ORG-000256

Aichi, , Japan

Site Status

Site Reference ID/Investigator# 68371

Akita, , Japan

Site Status

Site Reference ID/Investigator# 71098

Akita, , Japan

Site Status

Research facility ORG-000222

Akita, , Japan

Site Status

Research facility ORG-000129

Aomori, , Japan

Site Status

Research facility ORG-000133

Aomori, , Japan

Site Status

Site Reference ID/Investigator# 68378

Chiba, , Japan

Site Status

Site Reference ID/Investigator# 75790

Chiba, , Japan

Site Status

Research facility ORG-000162

Chiba, , Japan

Site Status

site REference ID/Investigator# 75798

Chiba, , Japan

Site Status

Research facility ID ORG-000246

Chiba, , Japan

Site Status

Site reference ID/Investigator# 88676

Chiba, , Japan

Site Status

Research facility ORG-000118

Chiba, , Japan

Site Status

Research facility ID ORG-000251

Ehime, , Japan

Site Status

Research facility ID ORG-000232

Ehime, , Japan

Site Status

Research facility ORG-000233

Ehime, , Japan

Site Status

Research facility ORG-000130

Ehime, , Japan

Site Status

Research facility ID ORG-000271

Fukui, , Japan

Site Status

Site reference ID/Investigator # 88674

Fukui, , Japan

Site Status

Research facility ORG-000094

Fukuoka, , Japan

Site Status

Research facility ID ORG-000269

Fukuoka, , Japan

Site Status

Investigator ID 117496

Fukuoka, , Japan

Site Status

Research facility ID ORG-000229

Fukuoka, , Japan

Site Status

Research facility ORG-000088

Fukuoka, , Japan

Site Status

Research facility ORG-000098

Fukuoka, , Japan

Site Status

Research facility ORG-000104

Fukuoka, , Japan

Site Status

Research facility ORG-000091

Fukuoka, , Japan

Site Status

Research facility ORG-000165

Fukuoka, , Japan

Site Status

Research facility ID ORG-000262

Fukuoka, , Japan

Site Status

Research facility ORG-000114

Fukuoka, , Japan

Site Status

Site Reference ID/Investigator# 84554

Fukushima, , Japan

Site Status

Research facility ID ORG-000207

Fukushima, , Japan

Site Status

Research facility ORG-000136

Fukushima, , Japan

Site Status

Research facility ID ORG-000177

Fukushima, , Japan

Site Status

Research facility ID ORG-000238

Gifu, , Japan

Site Status

Site reference ID/Investigator# 91833

Gifu, , Japan

Site Status

Research facility ORG-000139

Gunma, , Japan

Site Status

Research facility ID ORG-000272

Gunma, , Japan

Site Status

Site reference ID/Investigator # 84557

Gunma, , Japan

Site Status

Research facility ORG-000156

Hiroshima, , Japan

Site Status

Research facility ID ORG-000241

Hiroshima, , Japan

Site Status

Research facility ID ORG-000203

Hiroshima, , Japan

Site Status

Site reference ID/Investigator # 91835

Hiroshima, , Japan

Site Status

Site Reference ID/Investigator# 88698

Hiroshima, , Japan

Site Status

Site Reference ID/Investigator# 84515

Hiroshima, , Japan

Site Status

Research facility ORG-000155

Hiroshima, , Japan

Site Status

Research facility ID ORG-000213

Hokkaido, , Japan

Site Status

Research facility ORG-000097

Hokkaido, , Japan

Site Status

Research facility ID ORG-000220

Hokkaido, , Japan

Site Status

Research facility ID/Investigator # ORG-000221 / 86896

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 84535

Hokkaido, , Japan

Site Status

Research facility ID ORG-000250

Hokkaido, , Japan

Site Status

Site Reference ID# 84573

Hokkaido, , Japan

Site Status

Research facility ID ORG-000223

Hokkaido, , Japan

Site Status

Research facility ID ORG-000201

Hokkaido, , Japan

Site Status

Research facility ID ORG-000211

Hokkaido, , Japan

Site Status

Site reference ID/Investigator# 84575

Hokkaido, , Japan

Site Status

Research facility ORG-000140

Hokkaido, , Japan

Site Status

Research facility ORG-000142

Hyōgo, , Japan

Site Status

Research facility ID ORG-000225

Hyōgo, , Japan

Site Status

Research facility ORG-000159

Hyōgo, , Japan

Site Status

Research facility ORG-000160

Hyōgo, , Japan

Site Status

Research facility ORG-000163

Hyōgo, , Japan

Site Status

Site Reference ID/Investigator# 73816

Hyōgo, , Japan

Site Status

Research facility ORG-000152

Hyōgo, , Japan

Site Status

Site Reference ID/Investigator# 75804

Ibaraki, , Japan

Site Status

Research facility ID ORG-000249

Ibaraki, , Japan

Site Status

Research facility ID ORG-000181

Ibaraki, , Japan

Site Status

Investigator ID 117498

Ishikawa, , Japan

Site Status

Research facility ID ORG-000260

Kagawa, , Japan

Site Status

Research facility ORG-000107

Kagoshima, , Japan

Site Status

Site reference ID/Investigator# 91860

Kagoshima, , Japan

Site Status

Research facility ID ORG-000244

Kagoshima, , Japan

Site Status

Research facility ID ORG-000273

Kagoshima, , Japan

Site Status

Research facility ID ORG-000212

Kanagawa, , Japan

Site Status

Research facility ID ORG-000167

Kanagawa, , Japan

Site Status

Research facility ID ORG-000202

Kanagawa, , Japan

Site Status

Research faciliity ORG-000099

Kanagawa, , Japan

Site Status

Research facility ID ORG-000191

Kanagawa, , Japan

Site Status

Research facility ID ORG-000182

Kanagawa, , Japan

Site Status

Research facility ID ORG-000255

Kanagawa, , Japan

Site Status

Research facility ID ORG-000254

Kanagawa, , Japan

Site Status

Site reference ID/Investigator # 75802

Kanagawa, , Japan

Site Status

Research facility ORG-000154

Kochi, , Japan

Site Status

Research facility ID ORG-000166

Kochi, , Japan

Site Status

Research facility ORG-000113

Kumamoto, , Japan

Site Status

Site reference ID/Investigator # 75789

Kyoto, , Japan

Site Status

Research facility ORG-000150

Kyoto, , Japan

Site Status

Research facility ID ORG-000176

Kyoto, , Japan

Site Status

Research facility ORG-000153

Kyoto, , Japan

Site Status

Research faclity ORG-000112

Kyoto, , Japan

Site Status

Research facility ID ORG-000180

Kyoto, , Japan

Site Status

Research facility ID ORG-000196

Kyoto, , Japan

Site Status

Investigator ID 117503

Kyoto, , Japan

Site Status

Research facility ID ORG-000194

Kyoto, , Japan

Site Status

Research facility ID ORG-000237

Mie, , Japan

Site Status

Research facility ORG-000105

Mie, , Japan

Site Status

Research facility ORG-000147

Miyagi, , Japan

Site Status

Research facility ORG-000092

Miyagi, , Japan

Site Status

Research facility ORG-000093

Miyagi, , Japan

Site Status

Site reference ID/Investigator # 84561

Miyagi, , Japan

Site Status

Site Reference ID/Investigator# 84560

Miyagi, , Japan

Site Status

Investigator ID 117508

Miyazaki, , Japan

Site Status

Investigator ID 117507

Miyazaki, , Japan

Site Status

Site reference ID/Investigator# 96736

Nagano, , Japan

Site Status

Research facility ORG-000171

Nagano, , Japan

Site Status

Research facility ID ORG-000290

Nagano, , Japan

Site Status

Research facility ORG-000109

Nagano, , Japan

Site Status

Research facility ORG-000115

Nagano, , Japan

Site Status

Research facility ORG-000137

Nagasaki, , Japan

Site Status

Site reference ID/Investigator # 71102

Nara, , Japan

Site Status

Research facility ID ORG-000265

Nara, , Japan

Site Status

Research facility ORG-000100

Niigata, , Japan

Site Status

Research facility ORG-000102

Niigata, , Japan

Site Status

Research facility ORG-000267

Niigata, , Japan

Site Status

Research facility ID ORG-000193

Niigata, , Japan

Site Status

Site Reference ID/Investigator# 63982

Numakunai, , Japan

Site Status

Site reference ID/Investigator # 91836

Okayama, , Japan

Site Status

Research facility ORG-000268

Okayama, , Japan

Site Status

Research facility ID ORG-000231

Okayama, , Japan

Site Status

Site reference ID/Investigator # 91856

Okinawa, , Japan

Site Status

Site Reference ID/Investigator# 86894

Osaka, , Japan

Site Status

Research facility ORG-000117

Osaka, , Japan

Site Status

Research facility ORG-000095

Osaka, , Japan

Site Status

Research facility ID ORG-000183

Osaka, , Japan

Site Status

Research facility ORG-000089

Osaka, , Japan

Site Status

Research facility ORG-000090

Osaka, , Japan

Site Status

Research facility ORG-000106

Ōita, , Japan

Site Status

Investigator ID 117497

Ōita, , Japan

Site Status

Research facility ID ORG-000204

Saga, , Japan

Site Status

Research facility ORG-000157

Saitama, , Japan

Site Status

Research facility ORG-000143

Saitama, , Japan

Site Status

Research facility ID ORG-000189

Saitama, , Japan

Site Status

Research facility ORG-000135

Saitama, , Japan

Site Status

Research facility ID ORG-000190

Saitama, , Japan

Site Status

Research facility ID ORG-000173

Saitama, , Japan

Site Status

Research facility ID ORG-000199

Saitama, , Japan

Site Status

Site Reference ID/Investigator# 86895

Saitama, , Japan

Site Status

Research facility ORG-000172

Saitama, , Japan

Site Status

Site reference ID/Investigator# 96739

Saitama, , Japan

Site Status

Research facility ORG-000116

Shiga, , Japan

Site Status

Research facility ID ORG-000178

Shimane, , Japan

Site Status

Research facility ID ORG-000253

Shizuoka, , Japan

Site Status

Research facility ID ORG-000252

Shizuoka, , Japan

Site Status

Site Reference ID/Investigator# 91834

Shizuoka, , Japan

Site Status

Site reference ID/Investigator# 84576

Shizuoka, , Japan

Site Status

Research facility ID ORG-000239

Shizuoka, , Japan

Site Status

Research facility ORG-000126

Tochigi, , Japan

Site Status

Research facility ORG-000108

Tochigi, , Japan

Site Status

Research facility ORG-000146

Tokyo, , Japan

Site Status

Research facility ORG-000124

Tokyo, , Japan

Site Status

Research facility ORG-000132

Tokyo, , Japan

Site Status

Research facility ORG-000121

Tokyo, , Japan

Site Status

Research facility ORG-000164

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 84578

Tokyo, , Japan

Site Status

Investigator ID 117499

Tokyo, , Japan

Site Status

Research facility ORG-000110

Tokyo, , Japan

Site Status

Research facility ORG-000101

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 73824

Tokyo, , Japan

Site Status

Investigator ID 117504

Tokyo, , Japan

Site Status

Investigator ID 117505

Tokyo, , Japan

Site Status

Research facility ID ORG-000179

Tokyo, , Japan

Site Status

Research facility ORG-000138

Tokyo, , Japan

Site Status

Research facility ID ORG-000195

Tokyo, , Japan

Site Status

Research facility ORG-000161

Tokyo, , Japan

Site Status

Research facility ORG-000123

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 75777

Tokyo, , Japan

Site Status

Research facility ID ORG-000227

Tokyo, , Japan

Site Status

Research facility ORG-000158

Tokyo, , Japan

Site Status

Research facility ORG-000103

Tokyo, , Japan

Site Status

Investigator ID 117501

Tokyo, , Japan

Site Status

Research facility ORG-000151

Tokyo, , Japan

Site Status

Site reference ID/Investigator # 86913

Tottori, , Japan

Site Status

Research facility ID ORG-000243

Wakayama, , Japan

Site Status

Research facility ORG-000122

Yamagata, , Japan

Site Status

Research facility ID ORG-000263

Yamaguchi, , Japan

Site Status

Research facility ORG-000128

Yamaguchi, , Japan

Site Status

Research facility ID ORG-000266

Yamaguchi, , Japan

Site Status

Research facility ORG-000127

Yamanashi, , Japan

Site Status

Countries

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Japan

Other Identifiers

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P12-894

Identifier Type: -

Identifier Source: org_study_id

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