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NCT04450316 · ClinicalTrials.gov registry record · Phase 2
Low-dose Naltrexone for Bladder Pain Syndrome
A Phase 2 study, sponsored by Stanford University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
NCT04450316: Clinical Trial Phase 2 study, sponsored by Stanford University.
NCT04450316 is a Phase 2 study that was terminated before completion, run by Stanford University. The registered enrollment target is 29 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04450316, a Phase 2 study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
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.
Interventions
- DRUG Placebo
- DRUG Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2020-10-08 |
| Est. Completion | 2022-06-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04450316
The ClinicalTrials.gov registry entry for NCT04450316 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04450316 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04450316 about?
NCT04450316 is a clinical study titled "Low-dose Naltrexone for Bladder Pain Syndrome". 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 Un...
What is the current status of trial NCT04450316?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2020-10-08. Estimated completion is 2022-06-04.
What interventions are being tested in trial NCT04450316?
The interventions under investigation include: Placebo (DRUG), Naltrexone (DRUG).
Who is sponsoring clinical trial NCT04450316?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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