| September 7, 2007 |
| November 6, 2008 |
| September 2007 |
| June 2008 (final data collection date for primary outcome measure) |
| The primary objective of this study is to evaluate the efficacy of Uracyst® relative to vehicle placebo in patients with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) using the Global Response Assessment instrument (GRA). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] |
| The primary objective of this study is to evaluate the efficacy of Uracyst® relative to vehicle placebo in patients with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) using the Global Response Assessment instrument (GRA). |
| Complete list of historical versions of study NCT00527917 on ClinicalTrials.gov Archive Site |
| The secondary objectives of this study are to evaluate the efficacy of Uracyst® by using additional efficacy instruments and to collect additional safety data on the device. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] |
| The secondary objectives of this study are to evaluate the efficacy of Uracyst® by using additional efficacy instruments and to collect additional safety data on the device. |
| |
| A Pilot Clinical Investigation of the Efficacy and Safety of Uracyst® Versus Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome. |
| 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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Interstitial Cystitis |
- Device: Uracyst
- Device: placebo
|
- Experimental: Uracyst
- Placebo Comparator: placebo
|
| |
| |
| Completed |
| 50 |
| September 2008 |
| June 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Canada |
| |
| NCT00527917 |
| Gary Hoel Ph.D. Executive Director, Watson Laboratories Inc |
| UR07001 |
| Watson Pharmaceuticals |
|
| Study Director: |
Keshava Kumar, PhD |
Watson Pharmaceuticals |
|
|
| Watson Pharmaceuticals |
| November 2008 |
