URACYST® For the Treatment of GAG Deficient Interstitial Cystitis

NCT ID: NCT00150488

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2008-02-29

Brief Summary

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.

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.

Conditions

Painful Bladder Syndrome; Interstitial Cystitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Uracyst® single arm open label Treatment Group

Group Type: EXPERIMENTAL

Uracyst

Intervention Type: DEVICE

2% weekly for 6 weeks, monthly for 4 months

Interventions

Uracyst

2% weekly for 6 weeks, monthly for 4 months

Intervention Type: DEVICE

Other Intervention Names

chondroitin sulphate

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stellar Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Dr. J. Curtis Nickel

OTHER

Sponsor Role: lead

Responsible Party

Dr. J. Curtis Nickel

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Curtis Nickel, MD FRCSC

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Centre for Advanced Urological Research, Kingston General Hospital

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

Uracyst-Stellar

Identifier Type: -

Identifier Source: org_study_id