Painful bladder syndrome MedDRA version: 9.1 Level: LLT Classification code 10011796 Term: Cystitis interstitial
Conditions
Interventions
Trade Name: XOLAIR
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Omalizumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age > 18 years, weight 20-150 kg, total serological IgE 30-700 IU/mL, allergy as medical history, diagnosis of painful bladder syndrome with sympthoms present for at least 6 months. 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
Exclusion criteria: Pregnant of feeding women, significant clinical conditions (neoplasia, infections, emathological, renal, liver, cardiovascular, endocrine or gastrointestinal pathologies), urinary frequency < 5 urinations/day, ipersensitivity to Omalizumab ingredients including excipients, alcohol or drugs abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy of Omalizumab in the treatment of painful bladder syndrome;Secondary Objective: Not applicable;Primary end point(s): Evaluation of the efficacy of Omalizumab after 12 months treatment of painful bladder syndrome | — |
Countries
Italy
Outcome results
None listed