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IC PaIN Trial: Low-dose Naltrexone in IC/PBS
NCT04313972Phase 4
Key facts
- Status
- Terminated
- Start
- Sep 2021
- Primary completion
- Jan 2023
- Countries
- 1
- Sponsor
- Endeavor Health
- Modality
- Small Molecules
- Drugs
- naltrexone
- Conditions
- interstitial cystitis (IC)
01
Overview
Phase 4, randomised, double-blind trial in interstitial cystitis (IC) comparing Low-dose naltrexone with Placebo (2 arms). Primary endpoints: Interstitial Cystitis Symptom Index at 6 weeks and Visual Analog Scale at 6 weeks. Started Sep 2021; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Low-dose naltrexone
2mg nightly for 2 weeks, then 4mg nightly for 4 weeks + behavioral therapy
Placebo
Placebo capsules nightly + behavioral therapy
03
Who it enrols
Adult patients with a diagnosis of IC/PBS, treatment-naïve or washed out, excluding those with liver/kidney disease, active infection, or using opioids/sleep aids.
04
Endpoints
Primary
Interstitial Cystitis Symptom Index
Visual Analog Scale
Secondary
Interstitial Cystitis Problem Index
Change in Urinary Frequency
Change in Number of Nocturia
Change in Pelvic Pain and Urgency/Frequency Symptoms
Patient Perceived Quality of Life: SF-36
Adverse Effects
Medication Tolerability
Number of Days With Pain Medications
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