Omalizumab in Interstitial Cystitis/Bladder Pain Syndrome

Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Study ID
NCT01294878
Phase
PHASE3
Status
Completed

Conditions

  • Interstitial Cystitis
  • Painful Bladder Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • omalizumab — DRUG
    The omalizumab dose has been calculated on the basis of body weight and basal levels of total serum IgE. Treatment was administered subcutaneously every 2 or 4 weeks (according to the calculated total dose) for a total of 48 weeks. Each vial contained 150 mg of the active compound, therefore the number of injections for each administration varied between 1 and 3, depending on the total dose used.

Study Details

By hypothesising that Interstitial Cystitis is an allergic disorder of the urogenital system that is linked to mast-cells, current therapy with omalizumab may represent a potential non symptomatic strategy for the treatment of IC/BPS

Key Dates

Start date
Mar 31, 2009
Status verified
Dec 2010
Primary completion
Sep 30, 2010
Completion
Oct 31, 2010

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: treatment with omalizumab
    Treatment was administered subcutaneously every 2 or 4 weeks (according to the calculated total dose) for a total of 48 weeks. Each vial contained 150 mg of the active compound, therefore the number of injections for each administration varied between 1 and 3, depending on the total dose used

Primary Outcome Measure

visual analogue score (VAS) for pain and urgency- frequency [ Time Frame: 12 months ]

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