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

NCT01427725 | Completed Results

• 1 other identifier: P12-894
• Study Type: observational
• Target: 579
• Locations: 1 country
• Sites: 189

Brief Summary

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.

Conditions

Exocrine Pancreatic Insufficiency; Pancreatic Diseases; Digestive System Diseases

Keywords

Digestive System Diseases; Therapeutic Uses; Pancreatectomy; Gastrointestinal Agents; Pancreatic Diseases; Pancrelipase; Exocrine Pancreatic Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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

  At week 52

Secondary Outcomes (24)

• Degree of General Improvement

  At week 24

• Degree of General Improvement

  At week 52

• Nutritional Endpoints - BMI

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

• Nutritional Endpoints - Serum Total Protein

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

• Nutrition Endpoints - Albumin

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

Study Arms (1)

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

Interventions

Lipacreon DRUG

This study was an observational study and no intervention was specified

Lipacreon

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients with a history of hypersensitivity to the ingredient of LipaCreon.
• Patients with a history of hypersensitivity to porcine protein.

Sponsors & Collaborators

• Mylan Inc.: lead

Study Sites (189)

Research facility ID ORG-000247

Aichi, 440-0014, Japan

Location

Research facility ID ORG-000216

Aichi, 444-8553, Japan

Location

Research facility ID ORG-000214

Aichi, 448-8505, Japan

Location

Research facility ID ORG-000215

Aichi, 448-8505, Japan

Location

Research facility ORG-000096

Aichi, 451-0052, Japan

Location

Research facility ORG-000086

Aichi, 453-0016, Japan

Location

Research facility ORG-000120

Aichi, 457-0046, Japan

Location

Research facility ORG-000119

Aichi, 460-0001, Japan

Location

Research facility ID ORG-000208

Aichi, 460-0004, Japan

Location

Site reference ID/Investigator # 75775

Aichi, 467-860, Japan

Location

Research facility ID ORG-000256

Aichi, 488-0004, Japan

Location

Site Reference ID/Investigator# 68371

Akita, 010-0933, Japan

Location

Site Reference ID/Investigator# 71098

Akita, 011-0948, Japan

Location

Research facility ORG-000222

Akita, 018-5201, Japan

Location

Research facility ORG-000129

Aomori, 036-8171, Japan

Location

Research facility ORG-000133

Aomori, 037-0063, Japan

Location

Site Reference ID/Investigator# 68378

Chiba, 261-0005, Japan

Location

Site Reference ID/Investigator# 75790

Chiba, 262-8506, Japan

Location

Research facility ORG-000162

Chiba, 270-0114, Japan

Location

site REference ID/Investigator# 75798

Chiba, 275-0026, Japan

Location

Research facility ID ORG-000246

Chiba, 278-0005, Japan

Location

Site reference ID/Investigator# 88676

Chiba, 278-8501, Japan

Location

Research facility ORG-000118

Chiba, 285-8765, Japan

Location

Research facility ID ORG-000251

Ehime, 790-0067, Japan

Location

Research facility ID ORG-000232

Ehime, 790-8524, Japan

Location

Research facility ORG-000233

Ehime, 790-8524, Japan

Location

Research facility ORG-000130

Ehime, 799-0193, Japan

Location

Research facility ID ORG-000271

Fukui, 910-1193, Japan

Location

Site reference ID/Investigator # 88674

Fukui, 918-8503, Japan

Location

Research facility ORG-000094

Fukuoka, 800-0257, Japan

Location

Research facility ID ORG-000269

Fukuoka, 801-0864, Japan

Location

Investigator ID 117496

Fukuoka, 802-0077, Japan

Location

Research facility ID ORG-000229

Fukuoka, 803-0186, Japan

Location

Research facility ORG-000088

Fukuoka, 810-0041, Japan

Location

Research facility ORG-000098

Fukuoka, 811-1347, Japan

Location

Research facility ORG-000104

Fukuoka, 812-8582, Japan

Location

Research facility ORG-000091

Fukuoka, 814-0001, Japan

Location

Research facility ORG-000165

Fukuoka, 816-0864, Japan

Location

Research facility ID ORG-000262

Fukuoka, 830-0011, Japan

Location

Research facility ORG-000114

Fukuoka, 832-0077, Japan

Location

Site Reference ID/Investigator# 84554

Fukushima, 771-1603, Japan

Location

Research facility ID ORG-000207

Fukushima, 960-1295, Japan

Location

Research facility ORG-000136

Fukushima, 963-3401, Japan

Location

Research facility ID ORG-000177

Fukushima, 963-8563, Japan

Location

Research facility ID ORG-000238

Gifu, 500-8513, Japan

Location

Site reference ID/Investigator# 91833

Gifu, 509-5193, Japan

Location

Research facility ORG-000139

Gunma, 371-8511, Japan

Location

Research facility ID ORG-000272

Gunma, 373-8585, Japan

Location

Site reference ID/Investigator # 84557

Gunma, 379-2311, Japan

Location

Research facility ORG-000156

Hiroshima, 722-8508, Japan

Location

Research facility ID ORG-000241

Hiroshima, 730-0847, Japan

Location

Research facility ID ORG-000203

Hiroshima, 731-5116, Japan

Location

Site reference ID/Investigator # 91835

Hiroshima, 732-0046, Japan

Location

Site Reference ID/Investigator# 88698

Hiroshima, 736-0082, Japan

Location

Site Reference ID/Investigator# 84515

Hiroshima, 737-0193, Japan

Location

Research facility ORG-000155

Hiroshima, 739-1732, Japan

Location

Research facility ID ORG-000213

Hokkaido, 001-0033, Japan

Location

Research facility ORG-000097

Hokkaido, 003-0006, Japan

Location

Research facility ID ORG-000220

Hokkaido, 006-0811, Japan

Location

Research facility ID/Investigator # ORG-000221 / 86896

Hokkaido, 006-0811, Japan

Location

Site Reference ID/Investigator# 84535

Hokkaido, 006-0832, Japan

Location

Research facility ID ORG-000250

Hokkaido, 047-8550, Japan

Location

Site Reference ID# 84573

Hokkaido, 053-8567, Japan

Location

Research facility ID ORG-000223

Hokkaido, 060-0033, Japan

Location

Research facility ID ORG-000201

Hokkaido, 060-8543, Japan

Location

Research facility ID ORG-000211

Hokkaido, 060-8648, Japan

Location

Site reference ID/Investigator# 84575

Hokkaido, 085-0822, Japan

Location

Research facility ORG-000140

Hokkaido, 098-5551, Japan

Location

Research facility ORG-000142

Hyōgo, 650-0017, Japan

Location

Research facility ID ORG-000225

Hyōgo, 665-0881, Japan

Location

Research facility ORG-000159

Hyōgo, 669-2721, Japan

Location

Research facility ORG-000160

Hyōgo, 669-3301, Japan

Location

Research facility ORG-000163

Hyōgo, 671-1122, Japan

Location

Site Reference ID/Investigator# 73816

Hyōgo, 674-0061, Japan

Location

Research facility ORG-000152

Hyōgo, 679-4122, Japan

Location

Site Reference ID/Investigator# 75804

Ibaraki, 300-0047, Japan

Location

Research facility ID ORG-000249

Ibaraki, 311-4151, Japan

Location

Research facility ID ORG-000181

Ibaraki, 313-0062, Japan

Location

Investigator ID 117498

Ishikawa, 920-0265, Japan

Location

Research facility ID ORG-000260

Kagawa, 760-8557, Japan

Location

Research facility ORG-000107

Kagoshima, 891-0143, Japan

Location

Site reference ID/Investigator# 91860

Kagoshima, 897-0031, Japan

Location

Research facility ID ORG-000244

Kagoshima, 899-5112, Japan

Location

Research facility ID ORG-000273

Kagoshima, 899-5215, Japan

Location

Research facility ID ORG-000212

Kanagawa, 216-8511, Japan

Location

Research facility ID ORG-000167

Kanagawa, 221-0832, Japan

Location

Research facility ID ORG-000202

Kanagawa, 224-8503, Japan

Location

Research faciliity ORG-000099

Kanagawa, 236-0004, Japan

Location

Research facility ID ORG-000191

Kanagawa, 239-0831, Japan

Location

Research facility ID ORG-000182

Kanagawa, 244-0817, Japan

Location

Research facility ID ORG-000255

Kanagawa, 252-0380, Japan

Location

Research facility ID ORG-000254

Kanagawa, 252-0816, Japan

Location

Site reference ID/Investigator # 75802

Kanagawa, 256-0816, Japan

Location

Research facility ORG-000154

Kochi, 780-0041, Japan

Location

Research facility ID ORG-000166

Kochi, 780-8077, Japan

Location

Research facility ORG-000113

Kumamoto, 865-0005, Japan

Location

Site reference ID/Investigator # 75789

Kyoto, 600-8558, Japan

Location

Research facility ORG-000150

Kyoto, 602-8599, Japan

Location

Research facility ID ORG-000176

Kyoto, 603-8156, Japan

Location

Research facility ORG-000153

Kyoto, 606-8203, Japan

Location

Research faclity ORG-000112

Kyoto, 606-8507, Japan

Location

Research facility ID ORG-000180

Kyoto, 612-8065, Japan

Location

Research facility ID ORG-000196

Kyoto, 615-0003, Japan

Location

Investigator ID 117503

Kyoto, 623-0011, Japan

Location

Research facility ID ORG-000194

Kyoto, 624-0914, Japan

Location

Research facility ID ORG-000237

Mie, 510-0016, Japan

Location

Research facility ORG-000105

Mie, 514-8507, Japan

Location

Research facility ORG-000147

Miyagi, 980-0004, Japan

Location

Research facility ORG-000092

Miyagi, 980-0872, Japan

Location

Research facility ORG-000093

Miyagi, 980-0872, Japan

Location

Site reference ID/Investigator # 84561

Miyagi, 983-8512, Japan

Location

Site Reference ID/Investigator# 84560

Miyagi, 983-8512, Japan

Location

Investigator ID 117508

Miyazaki, 885-0023, Japan

Location

Investigator ID 117507

Miyazaki, 885-0083, Japan

Location

Site reference ID/Investigator# 96736

Nagano, 383-8505, Japan

Location

Research facility ORG-000171

Nagano, 384-8588, Japan

Location

Research facility ID ORG-000290

Nagano, 390-0848, Japan

Location

Research facility ORG-000109

Nagano, 390-8505, Japan

Location

Research facility ORG-000115

Nagano, 396-0025, Japan

Location

Research facility ORG-000137

Nagasaki, 857-0055, Japan

Location

Site reference ID/Investigator # 71102

Nara, 636-0802, Japan

Location

Research facility ID ORG-000265

Nara, 638-8521, Japan

Location

Research facility ORG-000100

Niigata, 942-0061, Japan

Location

Research facility ORG-000102

Niigata, 945-0047, Japan

Location

Research facility ORG-000267

Niigata, 957-0067, Japan

Location

Research facility ID ORG-000193

Niigata, 958-8533, Japan

Location

Site Reference ID/Investigator# 63982

Numakunai, 024-0004, Japan

Location

Site reference ID/Investigator # 91836

Okayama, 700-8530, Japan

Location

Research facility ORG-000268

Okayama, 710-0816, Japan

Location

Research facility ID ORG-000231

Okayama, 719-3193, Japan

Location

Site reference ID/Investigator # 91856

Okinawa, 904-2195, Japan

Location

Site Reference ID/Investigator# 86894

Osaka, 537-8511, Japan

Location

Research facility ORG-000117

Osaka, 540-0006, Japan

Location

Research facility ORG-000095

Osaka, 567-0035, Japan

Location

Research facility ID ORG-000183

Osaka, 573-1191, Japan

Location

Research facility ORG-000089

Osaka, 589-0014, Japan

Location

Research facility ORG-000090

Osaka, 589-0014, Japan

Location

Research facility ORG-000106

Ōita, 870-0036, Japan

Location

Investigator ID 117497

Ōita, 870-0924, Japan

Location

Research facility ID ORG-000204

Saga, 849-0916, Japan

Location

Research facility ORG-000157

Saitama, 331-0054, Japan

Location

Research facility ORG-000143

Saitama, 335-0035, Japan

Location

Research facility ID ORG-000189

Saitama, 345-0834, Japan

Location

Research facility ORG-000135

Saitama, 348-0053, Japan

Location

Research facility ID ORG-000190

Saitama, 349-0217, Japan

Location

Research facility ID ORG-000173

Saitama, 350-0018, Japan

Location

Research facility ID ORG-000199

Saitama, 350-1123, Japan

Location

Site Reference ID/Investigator# 86895

Saitama, 350-8550, Japan

Location

Research facility ORG-000172

Saitama, 358-0023, Japan

Location

Site reference ID/Investigator# 96739

Saitama, 359-1141, Japan

Location

Research facility ORG-000116

Shiga, 525-0066, Japan

Location

Research facility ID ORG-000178

Shimane, 693-8501, Japan

Location

Research facility ID ORG-000253

Shizuoka, 410-2295, Japan

Location

Research facility ID ORG-000252

Shizuoka, 426-0072, Japan

Location

Site Reference ID/Investigator# 91834

Shizuoka, 431-3192, Japan

Location

Site reference ID/Investigator# 84576

Shizuoka, 438-0085, Japan

Location

Research facility ID ORG-000239

Shizuoka, 439-0022, Japan

Location

Research facility ORG-000126

Tochigi, 329-0214, Japan

Location

Research facility ORG-000108

Tochigi, 329-2722, Japan

Location

Research facility ORG-000146

Tokyo, 105-0004, Japan

Location

Research facility ORG-000124

Tokyo, 113-8655, Japan

Location

Research facility ORG-000132

Tokyo, 113-8655, Japan

Location

Research facility ORG-000121

Tokyo, 116-0003, Japan

Location

Research facility ORG-000164

Tokyo, 132-0033, Japan

Location

Site Reference ID/Investigator# 84578

Tokyo, 135-0002, Japan

Location

Investigator ID 117499

Tokyo, 143-0013, Japan

Location

Research facility ORG-000110

Tokyo, 143-8541, Japan

Location

Research facility ORG-000101

Tokyo, 150-8935, Japan

Location

Site Reference ID/Investigator# 73824

Tokyo, 152-0002, Japan

Location

Investigator ID 117504

Tokyo, 160-0016, Japan

Location

Investigator ID 117505

Tokyo, 160-0016, Japan

Location

Research facility ID ORG-000179

Tokyo, 162-0055, Japan

Location

Research facility ORG-000138

Tokyo, 162-8666, Japan

Location

Research facility ID ORG-000195

Tokyo, 168-0082, Japan

Location

Research facility ORG-000161

Tokyo, 170-0013, Japan

Location

Research facility ORG-000123

Tokyo, 173-0004, Japan

Location

Site Reference ID/Investigator# 75777

Tokyo, 173-8606, Japan

Location

Research facility ID ORG-000227

Tokyo, 178-0064, Japan

Location

Research facility ORG-000158

Tokyo, 190-0014, Japan

Location

Research facility ORG-000103

Tokyo, 192-0046, Japan

Location

Investigator ID 117501

Tokyo, 194-0023, Japan

Location

Research facility ORG-000151

Tokyo, 194-0023, Japan

Location

Site reference ID/Investigator # 86913

Tottori, 683-0006, Japan

Location

Research facility ID ORG-000243

Wakayama, 641-8509, Japan

Location

Research facility ORG-000122

Yamagata, 990-0027, Japan

Location

Research facility ID ORG-000263

Yamaguchi, 742-0032, Japan

Location

Research facility ORG-000128

Yamaguchi, 745-8522, Japan

Location

Research facility ID ORG-000266

Yamaguchi, 755-0049, Japan

Location

Research facility ORG-000127

Yamanashi, 409-3898, Japan

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency; Pancreatic Diseases; Digestive System Diseases

Results Point of Contact

• Title: Medical affairs manager
• Organization: Medical affairs

+81-3-5656-0516

Study Officials

• Jun Kato, MD.,Ph.D.

  Abbott Japan Co.,Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 2, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 13, 2022
• Results First Posted: June 13, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

JP (189)