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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003952
Receipt No. R000004760
Scientific Title A multicenter, randomised, open-label study to evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis
Date of disclosure of the study information 2010/07/26
Last modified on 2014/01/27

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Basic information
Public title A multicenter, randomised, open-label study to evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis
Acronym Oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis
Scientific Title A multicenter, randomised, open-label study to evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis
Scientific Title:Acronym Oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis
Region
Japan

Condition
Condition ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Clinical response (Mayo score) at 2, 12 weeks after treatment.
Key secondary outcomes (1) Mean maximum tacrolimus blood concentration (Cmax), mean time of Cmax (tmax), mean area under the blood concentration-time curve (AUC), trough level at day1.
(2) Percentage of patients achieved trough tacrolimus whole blood levels between 10 and 15ng/ml within 2 weeks.
(3) Dose of tacrolimus at 2weeks.
(4) Safety

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 considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Fasting condition group: Tacrolimus ingestion 1 hour before meal
Interventions/Control_2 Fed condition group: Tacrolimus ingestion immediately following consumption of meal
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients with refractory (steroid resistance or steroid dependent), moderately active (Mayo score: 6-10) ulcerative colitis
(2) Candidate has to agree to be enrolled for the study under sufficient written informed consent.
Key exclusion criteria (1) Patients with severely active disease
(2) Patients have undergone a colectomy
(3) Patient having pregnancy or having the possibility of pregnancy
(4) Patient giving the breast to a baby
(5) Patient with severe renal dysfunction
(6) Patient with severe liver dysfunction
(7) Patient with severe infection
(8) Patients with malignant disease, history of malignancy
(9) Patients with past episode of severe drug allergy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Matsumoto
Organization Hyogo College of Medicine
Division name Department of lower gastroenterology
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6662
Email

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Hida
Organization Hyogo College of Medicine
Division name Department of lower gastroenterology
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6662
Homepage URL
Email hidan@hyo-med.ac.jp

Sponsor
Institute Department of lower gastroenterology, Hyogo College of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka Medical College
Osaka City University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 兵庫医科大学(兵庫県)、大阪医科大学(大阪府)、大阪市立大学医学部(大阪府)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2012 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 07 Month 26 Day
Last modified on
2014 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004760

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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