NCT00517868

Study of URG101 in Painful Bladder Syndrome and Interstitial Cystitis

Terminated Phase 2 Results posted Last updated 23 August 2024

What this trial tests

Phase 2 trial testing URG101 in Painful Bladder Syndrome in 28 participants. Terminated before completion.

Timeline

28 August 2007

Primary endpoint
28 February 2008

28 February 2008

Quick facts

Lead sponsor	Urigen
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	28
Start date	28 August 2007
Primary completion	28 February 2008
Estimated completion	28 February 2008
Sites	6 locations across United States

Drugs / interventions tested

• URG101 — full drug profile →
• Placebo

Conditions studied

• Painful Bladder Syndrome — all drugs for Painful Bladder Syndrome →
• Interstitial Cystitis — all drugs for Interstitial Cystitis →
• Bladder Pain Syndrome — all drugs for Bladder Pain Syndrome →

Sponsor

Urigen — full company profile →

Who can join

18 and older, any sex, with Painful Bladder Syndrome or Interstitial Cystitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Daytime Bladder Pain Intensity Primary · Through 12 hours

A calculation of average bladder pain intensity differences from baseline to 12 hours post-dose , as determined using an 11-point numerical rating scale (NRS) for bladder pain from time of dosing through 12 hours post dose. The 11-point NRS for bladder pain is a scale from 0 to 10, with 0 indicating no bladder pain and 10 indicating the worst imaginable bladder pain.

Group	Value	95% CI
Placebo	20.73	5.04 – 36.41
URG101	41.86	27.64 – 56.08

Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire Secondary · Through 12 hours

Percentage of subjects achieving ≥ 50% improvement in Question 3 of the PORIS questionnaire at 12 hours post-dose. The PORIS questionnaire is an assessment of the subject's condition after treatment compared to before treatment. In particular, Question 3 of the PORIS questionnaire asks subjects to select the category that best describes the overall change in their condition compared to before receiving study medication; the choices are: worse, no better (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), greatly improved (75% improvement), or symptoms

Group	Value	95% CI
Placebo	2
URG101	9

Change in Total Symptom Score Secondary · Through 12 hours

A calculation of the average percentage change of Total Symptom Score (including Pelvic/Bladder Pain and Urinary Urgency scales) differences from baseline to 12 hours post-dose, as determined using 11-point numerical rating scales (NRS) for Pelvic/Bladder Pain and Urinary Urgency from time of dosing through 12 hours post dose. The 11-point NRS for Pelvic/Bladder Pain is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'. The 11-point NRS for Urinary Urgency (pressure to urinate) is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'.

Group	Value	95% CI
Placebo	17.04	± 29.87
URG101	38.31	± 27.73

Change in Daytime Urinary Urgency Score Secondary · Through 12 hours

A calculation of average percentage change of Urinary Urgency differences from baseline to 12 hours post-dose, as determined using 11-point numerical rating scales (NRS) for Urinary Urgency from time of dosing through 12 hours post dose. The 11-point NRS for Urinary Urgency (pressure to urinate) is a scale from 0 to 10, with 0 indicating 'none' and 10 indicating the 'worst ever'.

Group	Value	95% CI
Placebo	13.30	± 30.53
URG101	34.50	± 30.21

Determination of Serum Lidocaine Levels Post Study Drug Administration Secondary · 1 hour post-dose

Single-timepoint serum lidocaine measure at one hour following intravesical study drug administration

Group	Value	95% CI
Evaluable URG101 Subjects	0.51	0.24 – 2.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Event (AE) collection timeframe: for the duration of study conduct (up to 3 study visits or 5 days total) through 24 hours post-last dose of placebo or study drug Serious Adverse Event (SAE) and All-Cause Mortality (ACM) collection timeframe: for the duration of study conduct (up to 3 study visits or 5 days total) through 30 days post-last dose of placebo or study drug. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/28 (0%)

Deaths: 0/28

URG101

Serious: 1/28 (4%)

Deaths: 0/28

Total

Serious: 1/28 (4%)

Deaths: 0/28

Serious adverse events (1 terms)

Reaction	System	Placebo	URG101	Total
Vaginal Bleeding	Reproductive system and breast disorders	—	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	Placebo	URG101	Total
Headache	Nervous system disorders	—	—	—
Bladder Discomfort/Pain/Burning	Renal and urinary disorders	—	—	—
Vaginal Pain	Reproductive system and breast disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Urethral Pain/Burn/Discomfort	Renal and urinary disorders	—	—	—
Urinary Urgency	Renal and urinary disorders	—	—	—
Hematuria	Renal and urinary disorders	—	—	—
Urinary Tract Infection	Infections and infestations	—	—	—

Most-reported serious reactions: Vaginal Bleeding.

Data from ClinicalTrials.gov NCT00517868 adverse events section.

Sponsor's own description

A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.