UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027918 |
|---|---|
| Receipt number | R000031980 |
| Scientific Title | Heparin-lidocaine intravesical injection therapy for refractory interstitial cystitis |
| Date of disclosure of the study information | 2017/06/25 |
| Last modified on | 2017/06/25 10:58:31 |
* 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
Heparin-lidocaine intravesical injection
therapy for refractory interstitial cystitis
Acronym
Heparin-lidocaine intravesical injection
therapy for interstitial cystitis
Scientific Title
Heparin-lidocaine intravesical injection
therapy for refractory interstitial cystitis
Scientific Title:Acronym
Heparin-lidocaine intravesical injection
therapy for interstitial cystitis
Region
| Japan |
Condition
Condition
interstitial cystitis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the heparin-lidocaine intravesical therapy for the patients with interstitial cystitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
urinary frequency
Key secondary outcomes
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
heparin-lidocaine intravesical therapy
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Recurrence of interstitial cystitis was observed in the cystoscopy
Key exclusion criteria
1. Patients with active urinary tract
infection, urinary tract hemorrhage,
urinary tract malignancy
2. Patients with systolic blood pressure
of 200 mmHg or more or less than 89 mmHg
and diastolic blood pressure of 80 mmHg
or more
3. Patients with serious liver and kidney dysfunction
4. Patients with drug hypersensitivity
such as allergies
5. Pregnant women and patients who may be pregnant or breast-feeding patients
6. Patients who participated in other
clinical studies within 4 months
7. Patients whose research managers
judged inappropriate as research subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyoshi Miyata |
Organization
Nagasaki University Hospital
Division name
Department of Urology and Renal transplantation
Zip code
Address
1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL
095-819-7340
int.doc.miya@m3.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Matsuo |
Organization
Nagasaki University Hospital
Division name
Department of Urology and Renal transplantation
Zip code
Address
1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL
095-819-7340
Homepage URL
tomo1228@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of Urology and Renal transplantation, Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Urology and Renal transplantation, Nagasaki University Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 06 | Month | 25 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | 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
| 2017 | Year | 06 | Month | 25 | Day |
Last modified on
| 2017 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031980
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
