Omalizumab in Interstitial Cystitis/Bladder Pain Syndrome

NCT01294878 | Completed Phase 3 DMC

• 1 other identifier: omalizumab-ic
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Interstitial Cystitis; Painful Bladder Syndrome

Keywords

anti-IgE treatment; interstitial cystitis/bladder pain syndrome; omalizumab

Outcome Measures

Primary Outcomes (1)

• visual analogue score (VAS) for pain and urgency- frequency

  subjective measurement of pain and urgency

  12 months

Secondary Outcomes (1)

• PUF questionnaire

  12 months

Study Arms (1)

treatment with omalizumab

EXPERIMENTAL

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

Drug: omalizumab

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.

Also known as: Xolair

treatment with omalizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Divisione Urologia IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Daniele Porru, MD

  Divisione Urologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: February 14, 2011
• Study Start: March 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 14, 2011

Record last verified: 2010-12

Locations

IT (1)