|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00919113 |
|
Date of registration:
|
11/06/2009 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome
|
|
Scientific 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 |
|
Date of first enrolment:
|
July 2009 |
|
Target sample size:
|
98 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00919113 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Lawrence A Hill, PharmD, MBA |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Watson Laboratories, Inc. |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Interstitial Cystitis
|
|
Painful Bladder Syndrome
|
|
Intervention(s)
|
|
Drug: 2% sodium chondroitin sulfate
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Global Response Assessment (GRA) Responders at Week 11.
[Time Frame: at week 11]
|
|
Secondary Outcome(s)
|
|
Interstitial Cystitis Symptom Index (ICSI) Responders at Week 11.
[Time Frame: at week 11]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|