Interstitial Cystitis, Painful Bladder Syndrome
Conditions
Keywords
Bladder Pain, GAG replacement therapy, IC/PBS
Brief 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.
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.
Interventions
DRUG2% sodium chondroitin sulfate
Weekly 20 mL Intravesical instillation
DRUGPlacebo
The identical buffer used in Uracyst for the same administration
Sponsors
Watson Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Response Assessment (GRA) Responders at Week 11. | at week 11 | subjects that indicated markedly improved or moderately improved on the GRA, LOCF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11. | at week 11 | Subjects that exhibited at least a 30% improvement from baseline in their total ICSI score, LOCF |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Uracyst 2% sodium chondroitin sulfate | 49 |
| Placebo identical buffer | 49 |
| Total | 98 |
Baseline characteristics
| Characteristic | Placebo | Uracyst | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 45 Participants | 90 Participants |
| Age Continuous | 46.8 years STANDARD_DEVIATION 14.1 | 44.4 years STANDARD_DEVIATION 14.6 | 45.6 years STANDARD_DEVIATION 14.3 |
| Region of Enrollment United States | 49 participants | 49 participants | 98 participants |
| Sex: Female, Male Female | 49 Participants | 49 Participants | 98 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / 49 | 18 / 49 |
| serious Total, serious adverse events | 1 / 49 | 2 / 49 |
Outcome results
Primary
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
Population: Efficacy analysis performed according to randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Uracyst | Global Response Assessment (GRA) Responders at Week 11. | 19 participants |
| Placebo | Global Response Assessment (GRA) Responders at Week 11. | 15 participants |
Secondary
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
Population: Efficacy analysis performed according to randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Uracyst | Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11. | 23 participants |
| Placebo | Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11. | 18 participants |