Trial Outcomes & Findings for URACYST® For the Treatment of GAG Deficient Interstitial Cystitis (NCT NCT00150488)

Last Updated: 2023-07-27

Results Overview

indicated by a marked or moderate improvement on a seven-point patient Global Response Assessment (GRA) scale compared with baseline

Recruitment status

COMPLETED

Study phase

Target enrollment

53 participants

Primary outcome timeframe

Week 10 (4 weeks after the initial six treatments

Results posted on

2023-07-27

Participant milestones
Measure	Uracyst Treatment Group Moderately/severely symptomatic Interstitial cystitis patients
Overall Study STARTED	53
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	0

Withdrawal data not reported

URACYST® For the Treatment of GAG Deficient Interstitial Cystitis

Baseline characteristics by cohort
Measure	Uracyst Treatment Group n=53 Participants Subjects with diagnosis of Interstitial Cystitis with positive potassium sensitivity test
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	53 participants n=5 Participants

Timeframe: Week 10 (4 weeks after the initial six treatments

indicated by a marked or moderate improvement on a seven-point patient Global Response Assessment (GRA) scale compared with baseline

Outcome measures
Measure	Uracyst Treatment Group n=53 Participants Subjects with diagnosis of Interstitial Cystitis with positive potassium sensitivity test
Percentage of Responders to Treatment	25 Participants

Timeframe: Baseline and 10 Weeks

Scale of 0-10; subjects report 0=no pain and 10 pain as bad as you can imagine.

Outcome measures
Measure	Uracyst Treatment Group n=53 Participants Subjects with diagnosis of Interstitial Cystitis with positive potassium sensitivity test
Change in Likert Pain Score From Baseline at 10 Weeks	-2.6 units on a scale 0-10 Standard Deviation 1.5

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Uracyst Treatment Goup n=53 participants at risk Uracyst® Uracyst: 2% weekly for 6 weeks, monthly for 4 months
Respiratory, thoracic and mediastinal disorders Upper respiratory	35.8% 19/53 • Number of events 19 • 4 months
Nervous system disorders unrelated pain	32.1% 17/53 • Number of events 17 • 4 months
Skin and subcutaneous tissue disorders Genital burning/discomfort	18.9% 10/53 • Number of events 10 • 4 months
Infections and infestations Urinary Tract Infection	11.3% 6/53 • Number of events 6 • 4 months
Gastrointestinal disorders Gastro intestinal	11.3% 6/53 • Number of events 6 • 4 months
Renal and urinary disorders Increased bladder symptoms (urgency, frequency, incontinence	11.3% 6/53 • Number of events 6 • 4 months

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