World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 28 December 2015
Main ID:  EUCTR2015-004495-30-FI
Date of registration: 20/10/2015
Prospective Registration: Yes
Primary sponsor: Oulu University Hospital
Public title: Safety of intravesical bladder instillations among patients with severe interstitial cystitis
Scientific title: Safety of intravesical bladder instillations among patients with severe interstitial cystitis
Date of first enrolment: 14/12/2015
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004495-30
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase: 
Countries of recruitment
Finland
Contacts
Name: Urologian avohoitoyksikkö   
Address:  Kajaanintie 50 90220 Oulu Finland
Telephone:
Email: markku.h.vaarala@ppshp.fi
Affiliation:  Oulu University Hospital
Name: Urologian avohoitoyksikkö   
Address:  Kajaanintie 50 90220 Oulu Finland
Telephone:
Email: markku.h.vaarala@ppshp.fi
Affiliation:  Oulu University Hospital
Key inclusion & exclusion criteria
Inclusion criteria:
Age min 20 years
IC/PBS according to SUFU-criteria minium duration of 6 months
No suspicion of bladder cancer based on urine cytology and cystoscopy (performed within one year)
AUA treatment algorhitm level 3 treatments given without sufficient response
Signed informed consent
Fertile women commitment to reliable pregnancy preventive method during the trial. Male commitment to abstinence of use of condom during intercourse for 2 days after bladder instillation
Suitable for cystectomy to treat IC/PBS
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion criteria:
Acute bacterial cystitis
Severe hypertension (over 160/100 mmHg)
Malignant disease within 5 years, excluding basal cell carcinoma
Radiation to pelvis
Residual urine over 150 ml
Significant renal detoriation
Allergy to cyclosporine
Pregnancy
Subject not suitable for trial based on investigator evaluation


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Interstitial cystitis and bladder pain syndrome
MedDRA version: 18.1 Level: LLT Classification code 10071166 Term: Bladder pain syndrome System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 18.1 Level: PT Classification code 10011796 Term: Cystitis interstitial System Organ Class: 10038359 - Renal and urinary disorders
Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
Intervention(s)

Trade Name: SANDIMMUN
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3

Primary Outcome(s)
Timepoint(s) of evaluation of this end point: Before every dose and after 4 hours of every dose, and End of trial visit at 30 (28-32) days.
Secondary Objective: The effect of dose to symptoms.
Primary end point(s): Greatest safe intravesical cyclosporine dose.
Definition of safe dose: measured cyclosporine concentration in blood <50.
Main Objective: Safety of intravesical cyclosporine among patients with severe interstitial cystitis/painful bladder syndrome.
Secondary Outcome(s)
Secondary end point(s): The effect of dose to symptoms.
Based on PORIS-questionnaire score.
Timepoint(s) of evaluation of this end point: Every visit from visit day 3 to End of trial visit at day 30 (28-32).
Secondary ID(s)
CYCLOIC-1
Source(s) of Monetary Support
Oulu University Hospital
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history