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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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23 December 2013 |
Main ID: |
EUCTR2010-021556-25-IT |
Date of registration:
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04/11/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Phase III, randomized, open-label, multicenter evaluation of efficacy and tolerability `of Ialuril (sodium hyaluronate-chondroitin sulfate) vs. dimethyl sulfoxide (DMSO) in women with interstitial cystitis / painful bladder syndrome (IC / BPS)
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Trascrizione fonetica
Dizionario - Visualizza dizionario dettagliato - IBSA 01-2010
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Scientific title:
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Phase III, randomized, open-label, multicenter evaluation of efficacy and tolerability `of Ialuril (sodium hyaluronate-chondroitin sulfate) vs. dimethyl sulfoxide (DMSO) in women with interstitial cystitis / painful bladder syndrome (IC / BPS)
Ascolta
Trascrizione fonetica
Dizionario - Visualizza dizionario dettagliato - IBSA 01-2010 |
Date of first enrolment:
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24/02/2011 |
Target sample size:
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Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021556-25 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Italy
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Female patients aged greater than or equal to 18 years 2. Diagnosis of IC / BPS resistant to first-line treatment of non-invasive or early observation 3. Presence of pain (pelvic pressure or discomfort) in relation to the bladder accompanied by at least one other urinary symptom such as persistent urge to urinate or frequent urination at least six months 4. Discomfort or pain during intercourse 5. Women of childbearing potential must have negative pregnancy test 6. Subjects in the four previous months have not participated in other trials. 7. Written informed consent. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: . Patients younger than 18 years 2. Male patients 3. Patients who are pregnant and / or lactation 4. Confusable Diseases as the main cause of urinary symptoms ( 5. Previous intravesical treatment for IC / BPS. .
Age minimum:
Age maximum:
Gender:
Female: yes Male: no
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Health Condition(s) or Problem(s) studied
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Interstitial Cystitis MedDRA version: 9.1
Level: HLGT
Classification code 10018188
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Intervention(s)
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Trade Name: RIMSO 50 Pharmaceutical Form: Bladder irrigation INN or Proposed INN: Dimethyl sulfoxide Concentration unit: g gram(s) Concentration type: equal Concentration number: .54-
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Primary Outcome(s)
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Primary end point(s): The primary endpoint will be represented by the visual-analogue scale (VAS) for pain assessment, graduation 0-100, administered at baseline and after 3 and 6 months
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Secondary Objective: Secondary objectives are: - Additional assessments related to pain / performance voiding - Evaluation of the tolerability of treatment administered - Measuring quality of life associated with health - Economic considerations on the cost of treatment versus intravesical DMSO Ialuril and pathology IC / BPS before treatment.
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Main Objective: Evaluating the effectiveness of Ialuril in patients with IC / BPS resistant to first-line treatment of non-invasive
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Secondary ID(s)
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IBSA 01-2010
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Source(s) of Monetary Support
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Results
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Results available:
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