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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024482
Receipt No. 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

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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
Email 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
Email ashida@med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028177

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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