Interstitial CystitisPhase 2NCT00919113

Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome

A Phase 2 study testing 2% sodium chondroitin sulfate in people with Interstitial Cystitis and Painful Bladder Syndrome, run by Watson Pharmaceuticals at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A new device for interstitial cystitis is compared to inactive control to determine if it is safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Interstitial Cystitis, Painful Bladder Syndrome
What is being tested?: 2% sodium chondroitin sulfate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 98 participants
Where: 20 sitesUnited States
Study dates: Jul 2009to Dec 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Are a female, 18 years or older
Have been diagnosed with IC/PBS
Are willing to provide written informed consent and authorization to disclose after being fully informed of the risks of participation

Who cannot join

Are lactating females
Have previously received investigational products or devices within 30 days of screening
Have previously received Uracyst
Are currently receiving therapy with Interstim®
Have any other condition/disease which, in the opinion of the investigator, could compromise subject safety or confound the interpretation of study results
Are unable or unwilling to comply with protocol requirements

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Study site
Albany, New York, 12206
Study site
Boulder, Colorado, 80304
Study site
Coeur d'Alene, Idaho, 83814
Study site
Columbus, Georgia, 31904
Study site
Denver, Colorado, 80211
Study site
Englewood, New Jersey, 07601
Study site
Evanston, Illinois, 60201
Study site
Farmington, Connecticut, 06032
Study site
Las Vegas, Nevada, 89148
Study site
Melrose Park, Illinois, 60160
Study site
Mountlake Terrace, Washington, 98043
Study site
Oklahoma City, Oklahoma, 73104
Study site
Philadelphia, Pennsylvania, 19104
Study site
Plantation, Florida, 33317
Study site
Poughkeepsie, New York, 12601
Study site
Royal Oak, Michigan, 48073
Study site
Sewell, New Jersey, 08080
Study site
Wellington, Florida, 33414
Study site
Winston-Salem, North Carolina, 27103
Study site
Woodlane, New Jersey, 08060

Other trials in United States

About this study

Official title: A Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Effectiveness and Safety of Uracyst® Compared to Inactive Control in Subjects With Interstitial Cystitis/Painful Bladder Syndrome

A new device for interstitial cystitis is compared to inactive control to determine if it is safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period.

Read the detailed description

Multi-center, randomized, double-blind, parallel, 8 weekly instillations over a 7-week period with post-treatment follow-up for an additional 19 weeks for a total study length of 26 weeks.

Conditions: Interstitial Cystitis, Painful Bladder Syndrome
Being tested: 2% sodium chondroitin sulfate, Placebo
Keywords: Bladder Pain, GAG replacement therapy, IC/PBS
Medical subject headings: Cystitis, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

2% sodium chondroitin sulfateDrug
Also called Uracyst
Weekly 20 mL Intravesical instillation
PlaceboDrug
Also called buffer
The identical buffer used in Uracyst for the same administration

Study groups in NCT00919113
Study group	Role	What they receive
8 weekly bladder instillations of Uracyst	Experimental	20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period Receives: Drug: 2% sodium chondroitin sulfate
8 weekly bladder instillations of inactive control	Placebo comparator	20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Global Response Assessment (GRA) Responders at Week 11.
subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF
Measured: at week 11

Secondary outcomes (1)

Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.
Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF
Measured: at week 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Dec 2010

First posted12 Jun 2009 (estimated)
Study startJul 2009
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00919113
Sponsor's protocol ID: UR08004
Status last verified: May 2013
First submitted: 11 Jun 2009
Last updated: 3 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome

All Interstitial Cystitis trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2013. 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 Effectiveness and Safety of Uracyst® Compared to Inactive Control in Subjects With Interstitial Cystitis/Painful Bladder Syndrome
ClinicalTrials.gov ID: NCT00919113
Acronym / sponsor ID: UR08004
Conditions: Interstitial Cystitis, Painful Bladder Syndrome
Keywords: Bladder Pain, GAG replacement therapy, IC/PBS
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: Watson PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 12 Jun 2009 (estimated)
Results: Posted 3 May 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A new device for interstitial cystitis is compared to inactive control to determine if it is safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period.

Detailed description

Multi-center, randomized, double-blind, parallel, 8 weekly instillations over a 7-week period with post-treatment follow-up for an additional 19 weeks for a total study length of 26 weeks.

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
8 weekly bladder instillations of Uracyst	Experimental	Drug: 2% sodium chondroitin sulfate20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period
8 weekly bladder instillations of inactive control	Placebo comparator	Drug: Placebo20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Are a female, 18 years or older
Have been diagnosed with IC/PBS
Are willing to provide written informed consent and authorization to disclose after being fully informed of the risks of participation

Key exclusion criteria (6 listed)

Are lactating females
Have previously received investigational products or devices within 30 days of screening
Have previously received Uracyst
Are currently receiving therapy with Interstim®
Have any other condition/disease which, in the opinion of the investigator, could compromise subject safety or confound the interpretation of study results

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
2% sodium chondroitin sulfateAlso: UracystWeekly 20 mL Intravesical instillation	Drug	8 weekly bladder instillations of Uracyst
PlaceboAlso: bufferThe identical buffer used in Uracyst for the same administration	Drug	8 weekly bladder instillations of inactive control

Primary outcome

Global Response Assessment (GRA) Responders at Week 11.
Time frame: at week 11
subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF

1 secondary outcome

Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.
Time frame: at week 11

Results and safety

Results posted to the registry on 3 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Uracyst	50	41
Placebo	48	40

Primary outcome: Global Response Assessment (GRA) Responders at Week 11.

Time frame: at week 11. Number. Unit: participants

Measure	Uracyst n = 50	Placebo n = 48
Value	19	15

Population analysed: Efficacy analysis performed according to randomized treatment.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Uracyst	1 of 49 (2%)	21 of 49 (42.9%)	Not reported
Placebo	2 of 49 (4.1%)	18 of 49 (36.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Interstitial Cystitis

Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer
Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Recruiting
Investigation of PEMF Therapy for Female Patients With IC/BPS
Interstitial Cystitis, Chronic Interstitial Cystitis
Recruiting
Aerobic Exercise and Connective Tissue Massage in Painful Bladder Syndrome
Bladder Pain Syndrome, Painful Bladder Syndrome

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.

Lawrence A Hill, PharmD, MBA study director

Watson Laboratories, Inc.

20 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 2% sodium chondroitin sulfate in people with Interstitial Cystitis and Painful Bladder Syndrome, run by Watson Pharmaceuticals at 20 sites in United States.

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 3 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 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. 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?

Yes. Results are posted in the registry (first posted 3 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Global Response Assessment (GRA) Responders at Week 11. (time frame: at week 11). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00919113.

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 3 May 2013.