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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: EUCTR
Last refreshed on: 23 December 2013
Main ID:  EUCTR2010-021556-25-IT
Date of registration: 04/11/2010
Prospective Registration: Yes
Primary sponsor: IBSA
Public title: 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
Scientific title: 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: 24/02/2011
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021556-25
Study type:  Interventional clinical trial of medicinal product
Study design:  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  
Phase: 
Countries of recruitment
Italy
Contacts
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Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Interstitial Cystitis
MedDRA version: 9.1 Level: HLGT Classification code 10018188
Intervention(s)

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-

Primary Outcome(s)
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
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.
Main Objective: Evaluating the effectiveness of Ialuril in patients with IC / BPS resistant to first-line treatment of non-invasive
Secondary Outcome(s)
Secondary ID(s)
IBSA 01-2010
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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