UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024482 |
|---|---|
| Receipt number | R000028177 |
| Scientific Title | Investigator-initiated phase I/IIa clinical trial to assess the safety and efficacy of 11beta-HSD1 inhibitor in patients with the refractory Cushing syndrome and subclinical Cushing syndrome. |
| Date of disclosure of the study information | 2016/11/12 |
| Last modified on | 2016/10/19 16:10:41 |
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Basic information
Public title
Investigator-initiated phase I/IIa clinical trial to assess the safety and efficacy of 11beta-HSD1 inhibitor in patients with the refractory Cushing syndrome and subclinical Cushing syndrome.
Acronym
Investigator-initiated clinical trial for 11beta-HSD1 inhibitor.
Scientific Title
Investigator-initiated phase I/IIa clinical trial to assess the safety and efficacy of 11beta-HSD1 inhibitor in patients with the refractory Cushing syndrome and subclinical Cushing syndrome.
Scientific Title:Acronym
Investigator-initiated clinical trial for 11beta-HSD1 inhibitor.
Region
| Japan |
Condition
Condition
The refractory Cushing syndrome and subclinical Cushing syndrome.
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy of 11beta-HSD1 inhibitor on glucose tolerance.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the response rate in AUCglucose during oral glucose tolerance test at Week 24.
Key secondary outcomes
To assess the percent change from baseline in AUCglucose during oral glucose tolerance test at Week 24.
To assess the response rate and percent change from baseline in AUCglucose during oral glucose tolerance test at Week 12.
To assess the absolute and percent change from baseline in the following values.
Blood cortisol concentration, Urine cortisol, Salivary cortisol concentration, HbA1c, HOMA-IR, Diastolic and systolic blood pressure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of 200mg of 11beta-HSD1 inhibitor after dinner once a day for 12 weeks. After confirming the safety of the study, oral administration continues further 12 weeks. In case of the subjects with insufficient effect, administration dose will be increased to 400mg b.i.d for further 12 week.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Include the patients who match the following 8 criteria.
1) The patients with the age of 18 y ears old or more.
2) The patients diagnosed with the refractory Cushing syndrome or the subclinical Cushing syndrome.
3) The patients with impaired glucose tolerance or type 2 diabetes who are treated with alpha glucosidase inhibitor or diet exercise therapy.
4) The patients with HbA1c in the screening test less than 8.0 percent and with no change in the diabetes drug for at least 2 M prior to the study.
5) The patient who are capable of oral administration of the drug.
6) In case of men, the patients who agree to contraception or diagnosed with azoospermia.
7) In case of women, the patients who agree to contraception or diagnosed with infertility.
8) The patients who written consent has been obtained.
Key exclusion criteria
Exclude the patients who correspond to any of the following 12 criteria.
1) Patients with sever heart or blood diseases.
2) Patient with a high degree of renal dysfunction (eGFR<30mL/min/1.73 m2)
3) Patients with liver dysfunction (AST or ALT> 3x Upper limit )
4) Patients with acute or chronic infection that require treatment.
5) Patients with autoimmune or allergy diseases that require treatment.
6) Patients with present or a history of less than 5 years of malignancy with exception of ectopic ACTH syndrome.
7) Patients receiving metyrapone or trilostane within 1 week or mitotane within 3 months before first dose of 11beta-HSD1 inhibitor.
8) Patients with a history of drug allergies that interfere with participation in the clinical trial.
9) Patients with mental illness or its history that interfere with participation in the clinical trial.
10) Pregnant women, nursing mothers, or patients who do not agree to contraception during study period.
11) Patients participating in other clinical trial or clinical research and receiving the drug within 30 days before obtaining informed consent.
12) Patients who are deemed to be inappropriate by investigator or sharing physician from a medical point of view.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Nomura |
Organization
Kyushu University Hospital
Division name
Department of endocrine, metabolism and diabetes
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
092-642-5293
nomura@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Ashida |
Organization
Kyushu University Hospital
Division name
Department of endocrine, metabolism and diabetes
Zip code
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
092-642-5293
Homepage URL
ashida@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency of Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 19 | Day |
Last modified on
| 2016 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028177
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