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The study was terminated due to Food and Drug Administration (FDA) recalled the heparin used in the trial because of possible contamination.
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A double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of URG101 compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crossover | Other | Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2 |
|
| Crossover 2 | Other | URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| URG101 | Drug | Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Daytime Bladder Pain Intensity | 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. | Through 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire | 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 gone (100% improvement). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Proctor, M.D. | Georgia Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citrus Valley Medical Research | Glendora | California | 91741 | United States | ||
| SD Uro-Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22082303 | Background | Parsons CL, Zupkas P, Proctor J, Koziol J, Franklin A, Giesing D, Davis E, Lakin CM, Kahn BS, Garner WJ. Alkalinized lidocaine and heparin provide immediate relief of pain and urgency in patients with interstitial cystitis. J Sex Med. 2012 Jan;9(1):207-12. doi: 10.1111/j.1743-6109.2011.02542.x. Epub 2011 Nov 14. |
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A total of 28 participants received at least one dose in both Crossover Group 1 and Crossover Group 2. A third arm, All Dosed Subjects, has been listed to the Participant Flow section to allow for overall study Baseline Characteristics to be entered.
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| ID | Title | Description |
|---|---|---|
| FG000 | Crossover Group 1 | Placebo Treatment on Visit 1 followed by URG101 Treatment on Visit 2 URG101: Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week. Placebo: Liquid formulation without active URG101 drug components |
| FG001 | Crossover Group 2 | URG101 Treatment on Visit 1 followed by Placebo Treatment on Visit 2 URG101: Bladder instillation of URG101 or Placebo in random order on treatment 1 and treatment 2 followed by an open-label URG101 on treatment 3 within the same week. Placebo: Liquid formulation without active URG101 drug components |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects randomized per crossover arm as of the time of study termination.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants Dosed | Includes all participants who received at least one dose of URG101 or Placebo (Placebo: Liquid formulation without active URG101 drug) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Daytime Bladder Pain Intensity | 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. | Subjects included in this analysis must have received at least the first two dose administrations and must have been determined to be evaluable per the Statistical Analysis Plan. | Posted | Mean | 95% Confidence Interval | Percentage of pain scale change | Through 12 hours |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Inclusive of all AEs following placebo dose exposures. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal Bleeding | Reproductive system and breast disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
The study was intended to include 40 subjects, but it had to be terminated early because the Food and Drug Administration (FDA) unexpectedly recalled the heparin used in the trial due to a possible contamination.
Of the 28 subjects enrolled, limited demographic information is available, and the available data are reported for all subjects as a single group.
Of the 28 subjects enrolled, there were 18 evaluable full-crossover subjects for the statistical analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CEO | Vaneltix Pharma, Inc. | 732-354-3217 | info@vaneltix.com |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| D010146 | Pain |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Placebo | Drug | Liquid formulation without active URG101 drug components |
|
| Through 12 hours |
| Change in Total Symptom Score | 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'. | Through 12 hours |
| Change in Daytime Urinary Urgency Score | 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'. | Through 12 hours |
| San Diego |
| California |
| 92103 |
| United States |
| University of California, San Diego | San Diego | California | 92103 | United States |
| Scripps Clinic Medical Group | San Diego | California | 92130 | United States |
| Georgia Urology | Cartersville | Georgia | 30120 | United States |
| Urology San Antonio Research, P.A. | San Antonio | Texas | 78229 | United States |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| URG101 |
Inclusive of all subjects who received at least one URG101 (study drug) dose as either the first or second dose administration. |
|
|
|
| Secondary | Change in Question 3 of the Patient Overall Rating of Improvement of Symptoms (PORIS) Questionnaire | 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 gone (100% improvement). | Subjects included in this analysis must have received at least the first two dose administrations and must have been determined to be evaluable per the Statistical Analysis Plan. | Posted | Count of Participants | Participants | Through 12 hours |
|
|
|
| Secondary | Change in Total Symptom Score | 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'. | Subjects included in this analysis must have received at least the first two dose administrations and must have been determined to be evaluable per the Statistical Analysis Plan. | Posted | Mean | Standard Deviation | Percentage of change | Through 12 hours |
|
|
|
| Secondary | Change in Daytime Urinary Urgency Score | 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'. | Subjects included in this analysis must have received at least the first two dose administrations and must have been determined to be evaluable per the Statistical Analysis Plan. | Posted | Mean | Standard Deviation | Percentage of change | Through 12 hours |
|
|
|
| Post-Hoc | Determination of Serum Lidocaine Levels Post Study Drug Administration | Single-timepoint serum lidocaine measure at one hour following intravesical study drug administration | Subjects who received at least one dose of URG101 and met protocol and statistical analysis plan criteria to be deemed evaluable. | Posted | Mean | Full Range | µg/mL | 1 hour post-dose |
|
|
|
| 28 |
| 0 |
| 28 |
| 8 |
| 28 |
| EG001 | URG101 | Inclusive of all AEs following URG101 (study drug) dose exposures. | 0 | 28 | 1 | 28 | 21 | 28 |
| EG002 | Total | Inclusive of all AEs following all placebo and URG101 dose exposures. | 0 | 28 | 1 | 28 | 28 | 28 |
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Bladder Discomfort/Pain/Burning | Renal and urinary disorders | Non-systematic Assessment |
|
| Urethral Pain/Burn/Discomfort | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary Urgency | Renal and urinary disorders | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
|
| Vaginal Pain | Reproductive system and breast disorders | Non-systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |