Study Stopped
Revised project
Ulinastatin in Severe Acute Pancreatitis
Multicenter, Double-bind, Randomised, Placebo Controlled Study of Ulinastatin in Severe Acute Pancreatitis
1 other identifier
interventional
252
1 country
6
Brief Summary
This study aims to evaluate the effect of ulinastatin in the treatment and prevention of organ failure in severe acute pancreatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2010
Longer than P75 for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2010
CompletedFirst Posted
Study publicly available on registry
May 28, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJanuary 17, 2018
January 1, 2018
8.5 years
May 26, 2010
January 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
multiple organ dysfunction score
8 days
onset of (multiple) organ failure after randomized
8 days
Secondary Outcomes (6)
mortality
8 days, 14 days and 28 days
Incidence of complications
8 days, 14 days and 28 days
APACHE Ⅱ score
8 days
Need for surgical intervention
From admission to discharge
Hospital stay and ICU stay
From admission to discharge
- +1 more secondary outcomes
Study Arms (2)
ulinastatin group
EXPERIMENTALRegular treatments plus ulinastatin. Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.
placebo group
PLACEBO COMPARATORRegular treatment plus placebo. Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.
Interventions
Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.
Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of severe acute pancreatitis , severe acute pancreatitis adapted from the Atlanta classification:
- Early Prognostic Signs: Ramson signs ≥3, APACHE II score ≥8 Organ Failure and/or Local Complications: Necrosis, Abscess, Pseudocyst;
- Admission within 72h after onset of symptoms of pancreatitis
- years old
- Signed the informed consent form
You may not qualify if:
- Pre-existing chronic renal insufficiency requiring hemodialysis or peritoneal dialysis
- pre existing heart dysfunction or NYHA classification score above III
- pregnancy or lactation
- Allergy for ulinastatin
- Received an investigational drug or device within 90 days prior to entering study
- serious mentally-ill patients including dementia
- On the verge of death (estimated to be mortal in 12h).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Techpool Bio-Pharma Co., Ltd.lead
- Peking Union Medical College Hospitalcollaborator
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
- The first clinical college of harbin medical universitycollaborator
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- West China Hospitalcollaborator
- First Affiliated Hospital, Sun Yat-Sen Universitycollaborator
Study Sites (6)
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
The First Clinical College of Harbin University
Harbin, Heilongjiang, China
Wuhan Union Hospital of China
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
West China Hospital
Chengdu, Sichuan, China
Peking Union Medical College Hospital
Beijing, China
Related Publications (3)
Wang CY, Zhao YP. Progress of therapeutic effect in severe acute pancreatitis: Mini-review of treatment viewpoints and technique improvements. Chin J Surg 44(13): 872-4, 2006. (Article in Chinese)
RESULTMaehara K, Kanayama N, Halim A, el Maradny E, Oda T, Fujita M, Terao T. Down-regulation of interleukin-8 gene expression in HL60 cell line by human Kunitz-type trypsin inhibitor. Biochem Biophys Res Commun. 1995 Jan 26;206(3):927-34. doi: 10.1006/bbrc.1995.1131.
PMID: 7832806RESULTTsujino T, Komatsu Y, Isayama H, Hirano K, Sasahira N, Yamamoto N, Toda N, Ito Y, Nakai Y, Tada M, Matsumura M, Yoshida H, Kawabe T, Shiratori Y, Omata M. Ulinastatin for pancreatitis after endoscopic retrograde cholangiopancreatography: a randomized, controlled trial. Clin Gastroenterol Hepatol. 2005 Apr;3(4):376-83. doi: 10.1016/s1542-3565(04)00671-8.
PMID: 15822043RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yupei Zhao, MD
Peking Union Medical College Hospital
- PRINCIPAL INVESTIGATOR
Chunyou Wang, MD
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2010
First Posted
May 28, 2010
Study Start
June 1, 2010
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
January 17, 2018
Record last verified: 2018-01