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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01294878 |
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Date of registration:
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11/02/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Omalizumab in Interstitial Cystitis/Bladder Pain Syndrome
IComaliz |
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Scientific title:
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Explorative Study on the Use of Omalizumab in Patients Suffering From Interstitial Cystitis/Painful Bladder Syndrome |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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3 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01294878 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Italy
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Contacts
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Name:
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Daniele Porru, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Divisione Urologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female patients 18 years, with a range in body weight of 20 and 150 kg, who have
provided written informed consent
- In patients diagnosed with IC/PBS that underwent treatment, basal levels of total
serum IgE were 30 and 700 IU/ml and patients showed a positive allergic anamnesis
(asthma, rhinitis, atopic dermatitis, etc.)
- Diagnosis of IC/PBS was performed according to the criteria established by the
National Institute of Health Consensus Conference and patients had symptoms for at
least 3 months. Cytoscopy was performed according to the clinical indications
Exclusion Criteria:
- Pregnancy, breastfeeding. Fertile women that did not use secure contraceptive methods
(hormonal or double barrier method). Hysterectomized or surgically sterilized women
(tubal ligation) and menopause women were admitted into the study.
- Clinically relevant medical conditions (neoplasia, infections, hematologic, renal,
hepatic, cardiovascular, hormonal or gastrointestinal pathologies) within 3 months
prior to the study. Other specific criteria included patients with positive anamnesis
for bladder cancer or affected by actinic cystitis, vaginitis, symptomatic bladder or
urethral diverticulum, active genital herpes, bladder or urethral lithiasis.
- Urination frequency less than 5 times per day.
- Known hypersensitivity to any omalizumab component, excipients included (such as
monoclonal antibodies, polyclonal gamma globulins)
- Alcohol or drug abuse.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Painful Bladder Syndrome
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Interstitial Cystitis
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Intervention(s)
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Drug: omalizumab
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Primary Outcome(s)
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visual analogue score (VAS) for pain and urgency- frequency
[Time Frame: 12 months]
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Secondary Outcome(s)
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PUF questionnaire
[Time Frame: 12 months]
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Secondary ID(s)
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omalizumab-ic
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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