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TERMINATED
NCT04450316
PHASE2

Low-dose Naltrexone for Bladder Pain Syndrome

Sponsor: Stanford University

View on ClinicalTrials.gov

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.

Official title: Low-dose Naltrexone for Bladder Pain Syndrome: A Randomized Placebo-controlled Prospective Pilot Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2020-10-08

Completion Date

2022-06-04

Last Updated

2026-07-10

Healthy Volunteers

No

Interventions

DRUG

Naltrexone

4.5mg tab (low-dose) nightly

DRUG

Placebo

1 tab nightly

Locations (1)

Stanford Health Care

Stanford, California, United States