UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009214 |
|---|---|
| Receipt number | R000010817 |
| Scientific Title | Somatostatin (Sandostatin) Safety Study on Polycystic Kidney and Liver Disease: Phase II study |
| Date of disclosure of the study information | 2012/12/15 |
| Last modified on | 2014/05/03 15:27:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Somatostatin (Sandostatin) Safety Study on Polycystic Kidney and Liver Disease: Phase II study
Acronym
STOPCYST Phase II Safety Study
Scientific Title
Somatostatin (Sandostatin) Safety Study on Polycystic Kidney and Liver Disease: Phase II study
Scientific Title:Acronym
STOPCYST Phase II Safety Study
Region
| Japan |
Condition
Condition
Autosomal Dominant Polycystic Kidney Disease (ADPKD), Autosomal Dominant Polycystic Liver Disease (ADPLD).
Classification by specialty
| Gastroenterology | Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine safety of sandostatin administration to patients with ADPKD and ADPLD.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
1) vital signs, 2) adverse events, 3) laboratory data, 4) develpement of cholelithiasis
Key secondary outcomes
1) Change of liver and kidney volume measured with MRI (CT). 2) Change of QOL-related questionnaire score.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sandostatin
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patient with ADPKD and ADPLD, who consent to the protocol.
2. eGFR >45 ml/min/1.73m2
3. Patient who satisfy one or more following conditions
Liver volume >3000 ml
Total kidney volume >1000 ml
Two symptom score >3 or one symptom score >4
Key exclusion criteria
1) Subjects who are unlikely to adequately comply with trial's procedure.
2) Pregnant or lactating woman.
3) Subjects with uncontrolled or severe diabetes.
4) Subjects with allergy to octreotide or chemicals with similar structure to octreotide.
5) Subjects with comorbidity which interfare clinical evaluation.
6) Subjects with gall bladder stone.
7) Subjects who have scheduled surgery during trial.
8) Subjects taking other experimental therapies.
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Higashihara |
Organization
Kyorin University
Division name
School of Medicine, Dept. of Urology
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
ehigashi@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Higashihara |
Organization
Kyorin University
Division name
School of Medicine, Department of Urology
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
Homepage URL
ehigashi@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of Urology, School of Medicine, Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, School of Medicine, Kyorin University
Kyorin University Hospital
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 15 | 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
| 2012 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 29 | Day |
Last modified on
| 2014 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010817
