This is an open-label study that will enroll participants with Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS).
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 screening/dosing 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.
Enrolled and completed Study VNX001-111 (i.e., at any site that is concurrently conducting the VNX001-111 study, a subject must have previously enrolled and completed Study VNX001-111 to be eligible for entry into the VNX001-110 study) and meet all other inclusion/
Be able and willing to give a signed informed consent and to follow study instructions.
Be male or female, ≥ 18 years of age.
Have a history of IC/BPS for at least 9 months prior to the study, either treated (e.g. Elmiron®, RIMSO-50®), or untreated.
Have received a cystoscopy in association with their diagnosis of IC/BPS within 1 year of screening.
Vaneltix Pharma, Inc.
Lead sponsor
Prevail Infoworks
Collaborator