Low-dose Naltrexone for Bladder Pain Syndrome

Status Suspended

Clinical Trial Summary

Interstitial cystitis/Bladder Pain Syndrome (IC/PBS) is a constellation of symptoms of pelvic discomfort that includes both bladder-related pain as well as urinary frequency, urgency, and nocturia in the absence of an identifiable etiology that affects likely more than 5.4 million patients in the United States. There is a significant overlap in patients with IC/PBS and those with fibromyalgia and chronic pelvic pain syndrome. Low-dose naltrexone (LDN) has been shown to be effective for the treatment of chronic pain conditions. The primary aim of this study is to evaluate if LDN improves pain scores and lower urinary tract symptoms in patients with IC/PBS. A secondary aim is to show that it has a low adverse event profile.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04450316
Study type	Interventional
Source	Stanford University
Contact
Status	Suspended
Phase	Phase 2
Start date	October 8, 2020
Completion date	October 2024

View Details

See also
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
Terminated	`NCT02591199` - Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome	Phase 2
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
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