Unique ID issued by UMIN | UMIN000003952 |
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Receipt number | 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 08:39:23 |
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
Oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis
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
Oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis
Japan |
ulcerative colitis
Gastroenterology |
Others
NO
To evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis.
Safety,Efficacy
Exploratory
Pragmatic
Phase IV
Clinical response (Mayo score) at 2, 12 weeks after treatment.
(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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Medicine |
Fasting condition group: Tacrolimus ingestion 1 hour before meal
Fed condition group: Tacrolimus ingestion immediately following consumption of meal
16 | years-old | <= |
Not applicable |
Male and Female
(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.
(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
40
1st name | |
Middle name | |
Last name | Takayuki Matsumoto |
Hyogo College of Medicine
Department of lower gastroenterology
1-1 Mukogawa-cho, Nishinomiya, Hyogo
0798-45-6662
1st name | |
Middle name | |
Last name | Nobuyuki Hida |
Hyogo College of Medicine
Department of lower gastroenterology
1-1 Mukogawa-cho, Nishinomiya, Hyogo
0798-45-6662
hidan@hyo-med.ac.jp
Department of lower gastroenterology, Hyogo College of Medicine
None
Self funding
Osaka Medical College
Osaka City University
NO
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)
2010 | Year | 07 | Month | 26 | Day |
Unpublished
Completed
2010 | Year | 06 | Month | 01 | Day |
2010 | Year | 07 | Month | 01 | Day |
2012 | Year | 05 | Month | 01 | Day |
2010 | Year | 07 | Month | 26 | Day |
2014 | Year | 01 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004760
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