Interstitial Cystitis Clinical Trial
Official title:
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Multi-Center Single Dose Study to Evaluate the Safety and Effectiveness of URG101 Compared With the Individual Components Lidocaine and Heparin in Subjects With Interstitial Cystitis/Bladder Pain Syndrome
The purpose of this study is to determine if the combination product (URG101) is safe and effective versus its individual components (Heparin Sodium and Lidocaine Hydrochloride) for the treatment of Interstitial Cystitis/Bladder Pain Syndrome. The study is randomized and double-blinded such that neither the subject nor doctor will know which drug or placebo is received.
This is a Phase 2a, randomized, double-blind, placebo controlled, multicenter, single-dose,
pharmacokinetic study designed to determine the efficacy and safety of the combination
product (URG101) compared with its individual components (Heparin Sodium and Lidocaine
Hydrochloride).
Eligible subjects exhibiting moderate to severe symptoms of bladder pain associated with
their diagnosis of interstitial cystitis/bladder pain syndrome who have signed informed
consent, will be screened and provisionally enrolled for intravesical treatment.
On the day of study drug administration subjects will be randomized (2:1:2:1;
URG101:placebo:lidocaine:heparin) and will receive a single administration of one of four
intravesical treatments in a blinded fashion, based on random assignment:
1. URG101 (buffered lidocaine-heparin)
2. Placebo (phosphate buffer)
3. Lidocaine hydrocholoride buffered alone
4. Heparin sodium buffered alone
Efficacy and safety assessments will be completed for 24 hours after study drug
administration. End of Study Follow-up will be completed by telephone 48 to 72 hours after
study drug administration.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04313972 -
IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone
|
Phase 4 | |
Completed |
NCT03282318 -
A Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects With Bladder Pain Syndrome/Interstitial Cystitis
|
Phase 2 | |
Completed |
NCT03463499 -
The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients
|
N/A | |
Completed |
NCT02898220 -
Trans-MAPP II Study of Urologic Chronic Pelvin Pain
|
||
Completed |
NCT02247557 -
Intravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis
|
Phase 2 | |
Active, not recruiting |
NCT01731470 -
Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
|
N/A | |
Completed |
NCT01197261 -
OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)
|
Phase 2 | |
Completed |
NCT00971568 -
Urinary Biomarkers Characteristic to Interstitial Cystitis
|
N/A | |
Completed |
NCT00527917 -
A Pilot Clinical Investigation of the Efficacy and Safety of Uracyst® Versus Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.
|
Phase 2 | |
Completed |
NCT00150488 -
URACYST® For the Treatment of GAG Deficient Interstitial Cystitis
|
N/A | |
Recruiting |
NCT00094874 -
Acupuncture for the Treatment of Interstitial Cystitis (IC) Symptoms
|
Phase 3 | |
Terminated |
NCT00086684 -
Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis
|
Phase 4 | |
Recruiting |
NCT04845217 -
Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome
|
Phase 1/Phase 2 | |
Completed |
NCT04401176 -
Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome
|
Phase 2 | |
Recruiting |
NCT05147779 -
Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Peyronie's Disease, ED, and Interstitial Cystitis
|
Phase 1 | |
Suspended |
NCT04450316 -
Low-dose Naltrexone for Bladder Pain Syndrome
|
Phase 2 | |
Completed |
NCT04010513 -
Hypnosis for Bladder Pain Syndrome
|
N/A | |
Completed |
NCT05179460 -
A Study of Pentosan Polysulfate Sodium and the Development of Pigmentary Maculopathy and Pigmentary Retinopathy
|
||
Completed |
NCT02232282 -
Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT00546858 -
Relationship of Interstitial Cystitis to Vulvodynia
|
N/A |