Phase 2
N=98
Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome
Interstitial Cystitis · Painful Bladder Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00919113 ↗Enrolled (actual)
98
Serious AEs
3.1%
Results posted
May 2013
Primary outcome: Primary: Global Response Assessment (GRA) Responders at Week 11. — 19; 15 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 2% sodium chondroitin sulfate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Watson Pharmaceuticals
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Response Assessment (GRA) Responders at Week 11. |
19; 15 | — |
| SECONDARY Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11. |
23; 18 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00919113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.