Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394830
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-24
Brief Title:
Safety Efficacy and Frequency of Administration of VNX001 in the Treatment of Interstitial Cystitis Bladder Pain Syndrome ICBPS
Sponsor:
Vaneltix Pharma Inc
Organization:
Vaneltix Pharma Inc
Study Overview
Official Title:
A Phase 2b Open Label Single-Arm Multi-Center Multiple Dose 14-Day Study to Evaluate the Safety Efficacy and Frequency of Intravesical Administration of VNX001 in Acute Treatment of Subjects With Interstitial CystitisBladder Pain Syndrome ICBPS Who Have an Episode of Acute Bladder Pain of Moderate to Severe Intensity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 is an open-label study that will enroll participants with Interstitial Cystitis Bladder Pain Syndrome ICBPS
The study will assess PRN as needed dosing of up to 6 intravesical via catheter doses of VNX001 study drug to treat acute instances of moderate to severe bladder pain over a 14-day period The main aim of the study is to tally the number of doses and assess pain before and after doses The study will review the safety and tolerability of VNX001
Participants will need to attend up to seven 7 clinic visits 1 for screening and up to 6 visits for VNX001 dosing or at least one 1 clinic visit for a combined screeningdosing visit and 5 telephone visits over the course of 14 days Participants will also be asked complete a diary or telephone call each day of the study in order to record bladder pain urinary urgency side effects and medications taken
The study will assess PRN as needed dosing of up to 6 intravesical via catheter doses of VNX001 study drug to treat acute instances of moderate to severe bladder pain over a 14-day period The main aim of the study is to tally the number of doses and assess pain before and after doses The study will review the safety and tolerability of VNX001
Participants will need to attend up to seven 7 clinic visits 1 for screening and up to 6 visits for VNX001 dosing or at least one 1 clinic visit for a combined screeningdosing visit and 5 telephone visits over the course of 14 days Participants will also be asked complete a diary or telephone call each day of the study in order to record bladder pain urinary urgency side effects and medications taken
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None