A Phase 2 interventional study of 2% sodium chondroitin sulfate and Placebo in Interstitial Cystitis and Painful Bladder Syndrome, sponsored by Watson Pharmaceuticals. Completed at 20 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-03.
Sponsored by Watson Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
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.
235 studies on the registry are indexed under Cystitis; 22 are open to participants now.
This study's enrollment of 98 is above the median of 60 across 170 interventional studies indexed under Cystitis.
Browse Cystitis studies →Watson Pharmaceuticals is the lead sponsor of 30 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
20 mL Uracyst (2% sodium chondroitin sulfate) per instillation; 8 instillations over a 7-week period
Drug: 2% sodium chondroitin sulfate
20 mL inactive control buffer (phosphate-buffered saline); 8 instillations over a 7-week period
Drug: Placebo
Weekly 20 mL Intravesical instillation
Also known as: Uracyst
The identical buffer used in Uracyst for the same administration
Also known as: buffer
Global Response Assessment (GRA) Responders at Week 11.
subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF
Time frame: at week 11
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
Time frame: at week 11
| Milestone | Uracyst | Placebo |
|---|---|---|
| Started | 50 | 48 |
| Received uracyst | 49 | 0 |
| Received placebo | 0 | 49 |
| Completed | 41 | 40 |
| Not completed | 9 | 8 |
subjects that indicated "markedly improved" or "moderately improved" on the GRA, LOCF
| participants | Uracyst | Placebo |
|---|---|---|
| Global Response Assessment (GRA) Responders at Week 11. | 19 | 15 |
Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF
| participants | Uracyst | Placebo |
|---|---|---|
| Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11. | 23 | 18 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Uracyst | — | 1/49 (2%) | 21/49 (42.9%) |
| Placebo | — | 2/49 (4.1%) | 18/49 (36.7%) |
| Event | Uracyst | Placebo |
|---|---|---|
| Rectal HaemorrhageGastrointestinal disorders | 1/49 | 0/49 |
| ColitisGastrointestinal disorders | 1/49 | 0/49 |
| Suicidal IdeationPsychiatric disorders | 0/49 | 1/49 |
| Angina PectorisCardiac disorders | 0/49 | 1/49 |
| Event | Uracyst | Placebo |
|---|---|---|
| SinusitisRespiratory, thoracic and mediastinal disorders | 8/49 | 3/49 |
| DysuriaRenal and urinary disorders | 6/49 | 4/49 |
| HeadachePsychiatric disorders | 1/49 | 6/49 |
| NauseaGastrointestinal disorders | 4/49 | 3/49 |
| Cystitis InterstitialRenal and urinary disorders | 2/49 | 4/49 |
| Urinary Tract InfectionRenal and urinary disorders | 4/49 | 2/49 |
| Bladder PainRenal and urinary disorders | 4/49 | 1/49 |
| ConstipationGastrointestinal disorders | 1/49 | 4/49 |
| Age, Categorical(Participants) | Uracyst | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 45 | 45 | 90 |
| >=65 years | 4 | 4 | 8 |
| Age Continuous(years) | Uracyst | Placebo | Total |
|---|---|---|---|
| Mean | 44.4 ± 14.6 | 46.8 ± 14.1 | 45.6 ± 14.3 |
| Sex: Female, Male(Participants) | Uracyst | Placebo | Total |
|---|---|---|---|
| Female | 49 | 49 | 98 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Uracyst | Placebo | Total |
|---|---|---|---|
| United States | 49 | 49 | 98 |
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Watson Pharmaceuticals