Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00150488
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2005-09-06
Brief Title:
URACYST For the Treatment of GAG Deficient Interstitial Cystitis
Sponsor:
Dr J Curtis Nickel
Organization:
Queens University
Study Overview
Official Title:
URACYST For the Treatment of GAG Deficient Interstitial Cystitis
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This protocol describes a multi-centre community based open label study designed to assess the efficacy and safety of intravesical sodium chrondroitin sulfate Uracyst in the treatment of patients with a clinical diagnosis of interstitial cystitis IC
The safety of the study product will be evaluated through the incidence of adverse events and from results of physical examinations and laboratory tests
The safety of the study product will be evaluated through the incidence of adverse events and from results of physical examinations and laboratory tests
Detailed Description:
The primary efficacy endpoint will be the percent responders to treatment as indicated by improvement on a seven-point Patient Global Assessment scale at week 10 after 6 treatments compared to baseline The patient evaluates the overall change in their condition as markedly improved moderately improved slightly improved no change slightly worse moderately worse or markedly worse
Secondary efficacy objectives will be as follows
1 Improvement in individual IC symptoms during the treatment period and at week 10 after 6 treatments compared to baseline
Pain and urgency scores 0-10 cm VAS will be obtained using patient on-site questionnaires prior to first treatment baseline and again for weeks 4 6 10 14 18 22 and 24
2 Change in Patient SymptomProblem Index scores over the course of the treatment until the end of study week 24 compared to baseline
The validated OLeary Symptom ProblemIndex will be completed prior to first treatment baseline and again for weeks 4 6 10 14 18 22 and 24
The validated PUF questionnaire will be completed prior to first treatment baseline and again for weeks 4 6 10 14 18 22 and 24
3 Change in patient condition every month throughout the therapy and treatment follow-up
In addition to measuring the change in patient condition at week 14 the Patient Global Assessment will be completed at weeks 4 6 10 14 18 22 and 24
Secondary efficacy objectives will be as follows
1 Improvement in individual IC symptoms during the treatment period and at week 10 after 6 treatments compared to baseline
Pain and urgency scores 0-10 cm VAS will be obtained using patient on-site questionnaires prior to first treatment baseline and again for weeks 4 6 10 14 18 22 and 24
2 Change in Patient SymptomProblem Index scores over the course of the treatment until the end of study week 24 compared to baseline
The validated OLeary Symptom ProblemIndex will be completed prior to first treatment baseline and again for weeks 4 6 10 14 18 22 and 24
The validated PUF questionnaire will be completed prior to first treatment baseline and again for weeks 4 6 10 14 18 22 and 24
3 Change in patient condition every month throughout the therapy and treatment follow-up
In addition to measuring the change in patient condition at week 14 the Patient Global Assessment will be completed at weeks 4 6 10 14 18 22 and 24
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None