Main
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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:
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EUCTR |
Last refreshed on:
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28 December 2015 |
Main ID: |
EUCTR2015-004495-30-FI |
Date of registration:
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20/10/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Safety of intravesical bladder instillations among patients with severe interstitial cystitis
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Scientific title:
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Safety of intravesical bladder instillations among patients with severe interstitial cystitis |
Date of first enrolment:
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14/12/2015 |
Target sample size:
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004495-30 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Finland
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Contacts
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Name:
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Urologian avohoitoyksikkö
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Address:
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Kajaanintie 50
90220
Oulu
Finland |
Telephone:
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Email:
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markku.h.vaarala@ppshp.fi |
Affiliation:
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Oulu University Hospital |
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Name:
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Urologian avohoitoyksikkö
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Address:
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Kajaanintie 50
90220
Oulu
Finland |
Telephone:
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Email:
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markku.h.vaarala@ppshp.fi |
Affiliation:
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Oulu University Hospital |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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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
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Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
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Intervention(s)
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Trade Name: SANDIMMUN Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: CICLOSPORIN CAS Number: 59865-13-3
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Primary Outcome(s)
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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.
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Secondary Objective: The effect of dose to symptoms.
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Primary end point(s): Greatest safe intravesical cyclosporine dose. Definition of safe dose: measured cyclosporine concentration in blood <50.
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Main Objective: Safety of intravesical cyclosporine among patients with severe interstitial cystitis/painful bladder syndrome.
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Secondary Outcome(s)
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Secondary end point(s): The effect of dose to symptoms.
Based on PORIS-questionnaire score.
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Timepoint(s) of evaluation of this end point: Every visit from visit day 3 to End of trial visit at day 30 (28-32).
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Secondary ID(s)
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CYCLOIC-1
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Source(s) of Monetary Support
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Oulu University Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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