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Low-dose Naltrexone for Bladder Pain Syndrome

NCT04450316 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-12-22

No results posted yet for this study

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.

Conditions

  • Bladder Pain Syndrome
  • Interstitial Cystitis

Interventions

DRUG

Naltrexone

4.5mg tab (low-dose) nightly

DRUG

Placebo

1 tab nightly

Sponsors & Collaborators

Principal Investigators

  • Craig V Comiter, MD · Stanford University

  • Phil Hanno, MD · Stanford University

  • Jennifer M Hah, MD, MS · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2024-07-31
Completion
2024-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04450316 on ClinicalTrials.gov