Interstitial CystitisPhase 2NCT00527917
A Pilot Clinical Investigation of the Efficacy and Safety of Uracyst® Versus Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.
A Phase 2 study testing Uracyst in people with Interstitial Cystitis, run by Watson Pharmaceuticals at 13 sites in Canada.
Trial summary
This is a pilot clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive either an active product (Uracyst®) or placebo intravesically via a bladder catheter weekly for 6 weeks, followed by 6 weeks of follow-up period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- Uracyst
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 13 sitesCanada
- Study dates
- Sep 2007to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are female of male patient 18 years or older
- Have been previously diagnosed with IC/PBS.
- Are willing to provide informed consent
- Available for the duration of the study including treatment and follow-up (12 weeks)
Who cannot join
- Pregnant or lactating female.
- Are currently or have previously received investigational drugs within thirty (30) days of screening.
- Previous therapy for IC/PBS
- Have any medical condition/disease that could interfere with patient compliance or interfere with interpretation of the study results.
- Are unable or unwilling to comply with protocol requirements
- Are unable to read, understand, and provide written informed consent.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Canada13 sites
Study site
Barrie, Ontario
Study site
Brantford, Ontario
Study site
Guelph, Ontario
Study site
Kentville, Nova Scotia
Study site
Kingston, Ontario
Study site
Kitchener, Ontario
Study site
Newmarket, Ontario
Study site
North Bay, Ontario
Study site
Surrey, British Columbia
Study site
Thunder Bay, Ontario
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
Study site
Victoria, British Columbia
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Efficacy and Safety of Uracyst® (Intravesical Sodium Chondroitin Sulfate) Versus Vehicle Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.
This is a pilot clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive either an active product (Uracyst®) or placebo intravesically via a bladder catheter weekly for 6 weeks, followed by 6 weeks of follow-up period.
- Conditions
- Interstitial Cystitis
- Being tested
- placebo, Uracyst
- Keywords
- IC/PBS, Interstitial Cystitis/Painful Bladder Syndrome
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDevice
Also called device vehicle
bladder instillation
UracystDevice
Also called sodium chondroitin sulfate
20 ml sterile solution for weekly intravesical instillation
| Study group | Role | What they receive |
|---|---|---|
| Uracyst | Experimental | Sodium chondroitin sulfate Receives: Device: Uracyst |
| Placebo | Placebo comparator | placebo Receives: Device: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis
Measured: Baseline to 6 weeks
Secondary outcomes (1)
Adverse event assessments
Measured: Throughout the study, first instillation to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Keshava Kumar, PhD, Study director, Watson Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527917
- Sponsor's protocol ID
- UR07001
- Status last verified
- Dec 2009
- First submitted
- 7 Sep 2007
- Last updated
- 9 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Efficacy and Safety of Uracyst® (Intravesical Sodium Chondroitin Sulfate) Versus Vehicle Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.
- ClinicalTrials.gov ID
- NCT00527917
- Acronym / sponsor ID
- UR07001
- Conditions
- Interstitial Cystitis
- Keywords
- IC/PBS, Interstitial Cystitis/Painful Bladder Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive either an active product (Uracyst®) or placebo intravesically via a bladder catheter weekly for 6 weeks, followed by 6 weeks of follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uracyst | Experimental | Device: UracystSodium chondroitin sulfate |
| Placebo | Placebo comparator | Device: placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are female of male patient 18 years or older
- Have been previously diagnosed with IC/PBS.
- Are willing to provide informed consent
- Available for the duration of the study including treatment and follow-up (12 weeks)
Key exclusion criteria (6 listed)
- Pregnant or lactating female.
- Are currently or have previously received investigational drugs within thirty (30) days of screening.
- Previous therapy for IC/PBS
- Have any medical condition/disease that could interfere with patient compliance or interfere with interpretation of the study results.
- Are unable or unwilling to comply with protocol requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboAlso: device vehiclebladder instillation | Device | Placebo |
| UracystAlso: sodium chondroitin sulfate20 ml sterile solution for weekly intravesical instillation | Device | Uracyst |
Primary outcome
Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis
Time frame: Baseline to 6 weeks
1 secondary outcome
Adverse event assessments
Time frame: Throughout the study, first instillation to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keshava Kumar, PhD study director
Watson Pharmaceuticals
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Uracyst in people with Interstitial Cystitis, run by Watson Pharmaceuticals at 13 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis (time frame: Baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2009.