drugset / Trial / NCT04450316

Low-dose Naltrexone for Bladder Pain Syndrome

NCT04450316

Phase 2 Terminated 29 enrolled Stanford University
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2020-10-08
Primary completion
2022-06-04
Completion
2022-06-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Naltrexone Small molecule 4.5 mg

Indications