JRCT ID: jRCT2080222245
Registered date:03/10/2013
Basic Information
Recruitment status | |
---|---|
Health condition(s) or Problem(s) studied | Ulcerative colitis |
Date of first enrollment | 03/10/2013 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : AJG511 INN of investigational material : budesonide Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investigational material : intrarectal |
Outcome(s)
Primary Outcome | Remission rate |
---|---|
Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 16age old |
---|---|
Age maximum | <= 69age old |
Gender | Both |
Include criteria | <Major Inclusion Criteria> Patients with lesions not exceeding the segment from the rectum to the sigmoid colon |
Exclude criteria | <Major Exclusion Criteria> - Patients with infections and deep mycosis against which no effective antimicrobial is available. - Patients with intolerance to or a history of allergic reaction to budesonide. |
Related Information
Primary Sponsor | Ajinomoto Pharmaceuticals Co., Ltd. |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-132294 |
Contact
Public contact | |
Name | |
Address | contact_ajis@ajinomoto.com |
Telephone | |
Affiliation | Ajinomoto Pharmaceuticals Co., Ltd. |
Scientific contact | |
Name | |
Address | contact_ajis@ajinomoto.com |
Telephone | |
Affiliation | Ajinomoto Pharmaceuticals Co., Ltd. |