URACYST® For the Treatment of GAG Deficient Interstitial Cystitis

NCT00150488 | Completed Results

• 1 other identifier: Uracyst-Stellar
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Painful Bladder Syndrome; Interstitial Cystitis

Keywords

PBS; Painful Bladder Syndrome; Interstitial Cystitis; chrondroitin sulfate

Outcome Measures

Primary Outcomes (1)

• Percentage of Responders to Treatment

  indicated by a marked or moderate improvement on a seven-point patient Global Response Assessment (GRA) scale compared with baseline

  Week 10 (4 weeks after the initial six treatments

Secondary Outcomes (1)

• Change in Likert Pain Score From Baseline at 10 Weeks

  Baseline and 10 Weeks

Study Arms (1)

1

EXPERIMENTAL

Uracyst® single arm open label Treatment Group

Device: Uracyst

Interventions

Uracyst DEVICE

2% weekly for 6 weeks, monthly for 4 months

Also known as: chondroitin sulphate

1

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. J. Curtis Nickel: lead
• Stellar Pharmaceuticals: collaborator

Study Sites (1)

Centre for Advanced Urological Research, Kingston General Hospital

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: J. Curtis Nickel
• Organization: Queen Unviersity

jcn@queensu.ca

613 548 2497

Study Officials

• Curtis Nickel, MD FRCSC

  Queen's University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Uracyst

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: September 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: February 1, 2008
• Last Updated: July 27, 2023
• Results First Posted: July 27, 2023

Record last verified: 2022-09

Locations

CA (1)