Status:
COMPLETED
URACYST® For the Treatment of GAG Deficient Interstitial Cystitis
Lead Sponsor:
Dr. J. Curtis Nickel
Collaborating Sponsors:
Stellar Pharmaceuticals
Conditions:
Painful Bladder Syndrome
Interstitial Cystitis
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
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 basel...
Eligibility Criteria
Inclusion
- Patients must meet the following eligibility criteria in order to be enrolled in this study.
- Clinical diagnosis of interstitial cystitis
- Legally majority female capable and willing to provide informed consent
- Negative blood test for pregnancy at baseline or assurance of previous surgery, condition or state rendering conception impossible
- A sterile bacterial urine culture no more than thirty (30) days prior to first treatment
- An average urinary frequency of at least 11 times per 24-hour day
- An average pain/discomfort score of 4 or greater on a 0-10cm VAS scale
- Available for the duration of the study including treatment and follow-up (4 months)
Exclusion
- Pregnant or lactating
- Currently receiving or having received investigational drugs thirty (30) days or less prior to screening
- Currently receiving or having had prior therapy with intravesical treatment (eg. Uracyst, Cystistat®, heparin or BCG)
- 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.)
- Currently receiving or having received prior therapy with oral pentosanpolysulfate (Elmiron) 3 months or less prior to screening
- IC symptoms relieved by antimicrobials, anticholinergics or antispasmodics
- Bladder capacity of greater than 500 ml on awake cystometry using liquid filling medium
- Neurologic disease affecting bladder function; any previous surgery or procedure having affected bladder function
- Current urinary tract infection (must be treated and have a negative culture before study entry)
- Current diagnosis of chemical, tuberculous or radiation cystitis
- History of bladder or lower ureteral calculi
- History of cancer within the last five years other than adequately treated non-melanoma skin cancers
- Active sexual transmitted disease
- Current vaginitis
- Endometriosis
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00150488
Start Date
September 1 2005
End Date
February 1 2008
Last Update
July 27 2023
Active Locations (1)
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1
Centre for Advanced Urological Research, Kingston General Hospital
Kingston, Ontario, Canada, K7L 3N6