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NCT04313972 · ClinicalTrials.gov registry record · Phase 4
IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone
A Phase 4 study, sponsored by Endeavor Health.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT04313972: Clinical Trial Phase 4 study, sponsored by Endeavor Health.
NCT04313972 is a Phase 4 study that was terminated before completion, run by Endeavor Health. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04313972, a Phase 4 study, was terminated before completion, sponsored by Endeavor Health.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
Interstitial cystitis/painful bladder syndrome (IC/PBS) is a debilitating condition with symptoms of urinary urgency, frequency, nocturia (waking up at night to void), and pain, without evidence of urinary tract infection or other identifiable causes. IC/PBS often coexists with other chronic pain syndromes, such as irritable bowel syndrome, chronic fatigue syndrome, and fibromyalgia. Several treatments exist for IC/PBS; some are not effective, others are time consuming for patients to receive, some can take weeks to months before they become effective, and many have risks associated with them. Low-dose naltrexone (LDN) has demonstrated improvement of symptoms in conditions associated with IC/PBS. LDN is defined as less than 5mg of naltrexone. Some adverse effects have been reported with LDN, the most common are vivid dreams, nightmares, and insomnia. The investigators hypothesis LDN will have greater than 30% reduction in symptoms as defined by the Interstitial Cystitis Symptom Index in patients diagnosed with IC/PBS from baseline when compared to placebo. The 30% reduction in pain is a standard outcome measure in the pain literature. This improvement has been seen in prior studies where LDN was used to treat pain syndromes. This will be a randomized double-blinded placebo-controlled prospective trial. Patients meeting diagnostic criteria for IC/PBS by American Urologic Association (AUA) guidelines will be eligible, and then must then meet all applicable inclusion and exclusion criteria. Study participants will sign a consent, complete several questionnaires, give a blood sample to measure liver function tests, and once at home, complete a 24-hour bladder diary. Participants will be randomized to receive either placebo or study medication. Participants will be instructed to take one capsule nightly for two weeks, then increase to two capsules nightly for four weeks. They will be given a log to record the date and time they take the medication. All study particip
Primary Outcome
The effect of LDN (low-dose naltrexone) in decreasing symptoms associated with IC/PBS (interstitial cystitis/painful bladder syndrome) when treating with low-dose naltrexone as scored by the Interstitial Cystitis Symptom Index as compared to placebo. Scores are from 0 to 20, with lower scores indicating less symptoms associated with IC/PBS.
Interventions
- DRUG Placebo oral tablet
- DRUG low-dose naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-09-07 |
| Est. Completion | 2023-02-23 |
| Phase | Phase 4 |
Why NCT04313972 stopped before completion
NCT04313972 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04313972 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04313972 about?
NCT04313972 is a clinical study titled "IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone". Interstitial cystitis/painful bladder syndrome (IC/PBS) is a debilitating condition with symptoms of urinary urgency, frequency, nocturia (waking up at night to void), and pain, without evidence of urinary tract infection or other identifiable causes. IC/PBS often coexists with other chronic pain sy...
What is the current status of trial NCT04313972?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2021-09-07. Estimated completion is 2023-02-23.
What interventions are being tested in trial NCT04313972?
The interventions under investigation include: Placebo oral tablet (DRUG), low-dose naltrexone (DRUG).
Who is sponsoring clinical trial NCT04313972?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04313972's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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