Omalizumab in Interstitial Cystitis/Bladder Pain Syndrome (IComaliz)

This study has been completed.
Sponsor:
Information provided by:
IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT01294878
First received: February 11, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Interstitial Cystitis
Painful Bladder Syndrome
Drug: omalizumab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Explorative Study on the Use of Omalizumab in Patients Suffering From Interstitial Cystitis/Painful Bladder Syndrome

Resource links provided by NLM:


Further study details as provided by IRCCS Policlinico S. Matteo:

Primary Outcome Measures:
  • visual analogue score (VAS) for pain and urgency- frequency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    subjective measurement of pain and urgency


Secondary Outcome Measures:
  • PUF questionnaire [ Time Frame: 12 months ]
    assessment of bladder pain and urinary frequency


Enrollment: 3
Study Start Date: March 2009
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: omalizumab
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.
Other Name: Xolair

Detailed Description:

Interstitial cystitis/Bladder Pain Syndrome is a chronic inflammatory disease of the bladder, that is characterized by pain in the pelvic region and a frequent need to urinate. So far there is not a an effective treatment for this uncommon distressing condition.

The objective of this preliminary study was to evaluate the efficacy of omalizumab in the treatment of Interstitial Cystitis/Bladder Pain Syndrome, evaluated by visual analogue score (VAS) for pain and urgency- frequency, O'Leary-Sant IC symptom and problem index questionnaire (primary outcome), PUF questionnaire and Patient Global Assessment questionnaire, and urination diary (secondary outcomes).

Three female adult patients (24-34 years) suffering form Interstitial Cystitis and chronic bladder pain were included in the study. 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. Patients were allowed to take drugs used for IC (Fibrase, Pelvilen, Normast, Quercetin, Chondroitin, Glucosamine per os). During the screening process, the dosage of these drugs was established and stably maintained during the 4 week run-in period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294878

Locations
Italy
Divisione Urologia IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
Investigators
Principal Investigator: Daniele Porru, MD Divisione Urologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
  More Information

No publications provided

Responsible Party: DANIELE PORRU MD, Divisione Urologia, Fondazione IRCCS Policlinico San Matteo, Viale Golgi 19, Pavia 27100, Italy
ClinicalTrials.gov Identifier: NCT01294878     History of Changes
Other Study ID Numbers: omalizumab-ic
Study First Received: February 11, 2011
Last Updated: February 11, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by IRCCS Policlinico S. Matteo:
anti-IgE treatment
interstitial cystitis/bladder pain syndrome
omalizumab

Additional relevant MeSH terms:
Cystitis
Pain
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 20, 2014