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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013925
Receipt No. R000016237
Official scientific title of the study The efficacy of treatmenst with both Ganciclovir and GMAA for patients with ulcerative colitis concomitant cytomegalovirus infection
Date of disclosure of the study information 2014/05/31
Last modified on 2016/05/11

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Basic information
Official scientific title of the study The efficacy of treatmenst with both Ganciclovir and GMAA for patients with ulcerative colitis concomitant cytomegalovirus infection
Title of the study (Brief title) KIBDG-Protocol 1
Region
Japan

Condition
Condition Ulcerative colitis
Classification by specialty
Medicine in general Gastroenterology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of treatment with both Ganciclovir and GMAA for patients with ulcerative colitis concomitant cytomegalovirus infection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Induction remission rate
Key secondary outcomes Response rate
Negativity of cytomegalovirus infection

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 A Group: Ganciclovir monotherapy
Interventions/Control_2 B Group: Ganciclovir and GMAA combination therapy
Interventions/Control_3 C Group: GMAA monotherapy
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with ulcerative colitis refractory to corticosteroids or immunomodulators
Key exclusion criteria 1: white blood cell counts<2000/mm3, Hb<8g/dl
2: severe cardiovascular disease, hepatic failure, Renal failure, Respiratory faiure, Nervous disease
3: Pregnancy
4: Inadequate patients for study
Target sample size 90

Research contact person
Name of lead principal investigator Tsutomu Chiba
Organization Graduate School of Medicine, Kyoto University
Division name Gastroenterology and Hepatology
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city, Kyoto, Japan
TEL 075-75-4319
Email chiba@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person Hiroshi Nakase
Organization Graduate School of Medicine, Kyoto University
Division name Gastroenterology and Hepatology
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city, Kyoto, Japan
TEL 075-75-4319
Homepage URL
Email hiropy_n@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Kyoto University, Gastroenterology and Hepatology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization JIMRO
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 京都大学病院(京都府)、京都桂病院(京都府)、京都第一赤十字病院(京都府)、京都第二赤十字病院(京都府)、三菱京都病院(京都府)、滋賀医科大学(滋賀県)、大津赤十字病院(滋賀県)、兵庫医科大学(兵庫県)、神戸市立中央市民病院(兵庫県)、西神戸医療センター(兵庫県)、神戸市立西市民病院(兵庫県)、関西医科大学附属枚方病院(大阪府)、大阪市立大学附属病院(大阪府)、近畿大学附属病院(大阪府)、北野病院(大阪府)、大阪赤十字病院(大阪府)、高槻病院(大阪府)、西下胃腸病院(大阪府)、JR大阪鉄道病院(大阪府)、青山内科胃腸科クリニック(兵庫県)、天理よろづ相談所病院(奈良県)、生駒消化器科クリニック(大阪府)

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 31 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2006 Year 11 Month 28 Day
Anticipated trial start date
2007 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2014 Year 05 Month 11 Day
Last modified on
2016 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016237


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