Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that was terminated before completion, run by Endeavor Health. The registered enrollment target is 3 participants.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04313972
The ClinicalTrials.gov registry entry for NCT04313972 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endeavor Health, which has 94 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04313972 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.