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URACYST® For the Treatment of GAG Deficient Interstitial Cystitis

This study has been completed.
Sponsor:
Collaborator:
Stellar Pharmaceuticals
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00150488
First received: September 6, 2005
Last updated: September 17, 2008
Last verified: September 2008
History of Changes
  Purpose

This protocol describes a multi-centre, community based open label study designed to assess the efficacy and safety of intravesical sodium chrondroitin sulfate (Uracyst®) in the treatment of patients with a clinical diagnosis of interstitial cystitis (IC).

The safety of the study product will be evaluated through the incidence of adverse events and from results of physical examinations and laboratory tests.


Condition Intervention Phase
Painful Bladder Syndrome
Interstitial Cystitis
 Device: Uracyst
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: URACYST® For the Treatment of GAG Deficient Interstitial Cystitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Percent responders to treatment compared to baseline [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in individual IC symptoms during the treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Patient Symptom/Problem Index scores [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Change in patient condition every month [ Time Frame: Monthly ] [ Designated as safety issue: No ]
  • The safety of the study product will be evaluated [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Enrollment: 53
Study Start Date: September 2005
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Uracyst®
 Device: Uracyst
2% weekly for 6 weeks, monthly for 4 months
Other Name: chondroitin sulphate

Detailed Description:

The primary efficacy endpoint will be the percent responders to treatment as indicated by improvement on a seven-point Patient Global Assessment scale at week 10 (after 6 treatments) compared to baseline. The patient evaluates the overall change in their condition as markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse or markedly worse.

Secondary efficacy objectives will be as follows:

  1. Improvement in individual IC symptoms during the treatment period and at week 10 (after 6 treatments) compared to baseline.

    Pain and urgency scores (0-10 cm VAS) will be obtained using patient on-site questionnaires prior to first treatment (baseline), and again for weeks 4, 6, 10, 14, 18, 22 and 24.

  2. Change in Patient Symptom/Problem Index scores over the course of the treatment until the end of study (week 24) compared to baseline.

    The validated O'Leary Symptom Problem/Index will be completed prior to first treatment (baseline) and again for weeks 4, 6, 10, 14, 18, 22 and 24.

    The validated PUF questionnaire will be completed prior to first treatment (baseline) and again for weeks 4, 6, 10, 14, 18, 22 and 24.

  3. Change in patient condition every month throughout the therapy and treatment follow-up.

In addition to measuring the change in patient condition at week 14, the Patient Global Assessment will be completed at weeks 4, 6, 10, 14, 18, 22 and 24.

  Eligibility

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

Inclusion Criteria:

Patients must meet the following eligibility criteria in order to be enrolled in this study.

  1. Clinical diagnosis of interstitial cystitis
  2. Legally majority female capable and willing to provide informed consent
  3. Negative blood test for pregnancy at baseline or assurance of previous surgery, condition or state rendering conception impossible
  4. A sterile bacterial urine culture no more than thirty (30) days prior to first treatment
  5. An average urinary frequency of at least 11 times per 24-hour day
  6. An average pain/discomfort score of 4 or greater on a 0-10cm VAS scale
  7. Available for the duration of the study including treatment and follow-up (4 months)

Exclusion Criteria:

  1. Pregnant or lactating
  2. Currently receiving or having received investigational drugs thirty (30) days or less prior to screening
  3. Currently receiving or having had prior therapy with intravesical treatment (eg. Uracyst, Cystistat®, heparin or BCG)
  4. Receiving therapy for less than three months with antidepressants, antihistaminics, hormonal agonists or antagonists; hence patient not stabilized on therapy. (Stable therapy defined as continuous treatment for at least three months.)
  5. Currently receiving or having received prior therapy with oral pentosanpolysulfate (Elmiron) 3 months or less prior to screening
  6. IC symptoms relieved by antimicrobials, anticholinergics or antispasmodics
  7. Bladder capacity of greater than 500 ml on awake cystometry using liquid filling medium
  8. Neurologic disease affecting bladder function; any previous surgery or procedure having affected bladder function
  9. Current urinary tract infection (must be treated and have a negative culture before study entry)
  10. Current diagnosis of chemical, tuberculous or radiation cystitis
  11. History of bladder or lower ureteral calculi
  12. History of cancer within the last five years other than adequately treated non-melanoma skin cancers
  13. Active sexual transmitted disease
  14. Current vaginitis
  15. Endometriosis
  16. Any condition/disease which in the opinion of the investigator could interfere with patient compliance and/ or interfere with the interpretation of the treatment results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00150488

Locations
Canada, Ontario
Centre for Advanced Urological Research, Kingston General Hospital
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Queen's University
Stellar Pharmaceuticals
Investigators
Principal Investigator: Curtis Nickel, MD FRCSC Queen's University
  More Information

No publications provided

Responsible Party: Dr. J. Curtis Nickel, Queen's University
ClinicalTrials.gov Identifier: NCT00150488     History of Changes
Other Study ID Numbers: Uracyst-Stellar, Investigator Initiated
Study First Received: September 6, 2005
Last Updated: September 17, 2008
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
PBS
Painful Bladder Syndrome
Interstitial Cystitis
chrondroitin sulfate

Additional relevant MeSH terms:
Cystitis
Pain
Cystitis, Interstitial
Urinary Bladder Diseases
 Urologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013