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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower). 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.
Primary Outcome
The Numeric Rating Scale (NRS) of Pain uses an 11-point likert scale. Scores ranges from a minimum of 0 (No pain) to a maximum of 10 (Worst Pain Imaginable). Higher scores indicate greater pain intensityThe proportion of subjects in the LDN and placebo groups that are responders with greater than 20% reductions in the worst daily Numeric Rating Scale of Pain scores after 8 weeks of treatment.
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 |
Why NCT04450316 stopped before completion
NCT04450316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04450316 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04450316's enrollment target sits among peer trials
29 1669th of 2000 higher than 324 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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