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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 August 2016
Main ID:  NCT01346826
Date of registration: 02/05/2011
Prospective Registration: Yes
Primary sponsor: Asan Medical Center
Public title: Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD)
Scientific title: Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial
Date of first enrolment: May 2011
Target sample size: 145
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01346826
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Korea, Republic of
Contacts
Name:     Suk-Kyun Yang, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients receiving infliximab for Crohn's disease or ulcerative colitis

- Ethnicity: Korean

- Patients who did not show any infusion reactions during 4 times of infliximab
(5mg/kg) infusions for 2 hours

- Informed consents

Exclusion Criteria:

- Sever cardiopulmonary diseases

- Allergic diseases

- Bronchial asthma

- Allergic rhinitis

- Atopic dermatitis

- Other allergic diseases determined not suitable for study participation by
investigators

- Severe liver disease

- Severe renal disease

- Body weight over 100 kg

- Other medical or surgical disease determined not suitable for study participation by
investigators



Age minimum: 16 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Ulcerative Colitis
Intervention(s)
Drug: Accelerated 1 hour-infusion
Drug: Accelerated 30 minutes-infusion
Drug: Standard 2 hours-infusion
Primary Outcome(s)
Total numbers of infusion reactions related with infliximab infusion [Time Frame: Within14 days after infliximab infusion]
Secondary Outcome(s)
Numbers of severe infusion reactions related with infliximab infusion [Time Frame: Within14 days after infliximab infusion]
Secondary ID(s)
2011-0181
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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