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drugset / Trial / NCT04167085

NOrth American Study for the Treatment of Recurrent epIstaxis With DoxycycLine: The NOSTRIL Trial

NCT04167085 ↗

Phase 4 Completed 26 enrolled University of California, Los Angeles
RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this research study is to determine whether Doxycycline can be used to control nosebleeds (epistaxis) for patients with Hereditary Hemorrhagic Telangiectasia (HHT). Patients with HHT will be randomized to one of 2 study arms: Doxycycline or Placebo for a period of 2 months followed by a 1-month washout period before switching treatments for a further 2 months period. Observation and evaluation will continue for a period of one month after treatment is completed.

Timeline

Start
2017-12-18
Primary completion
2021-06-01
Completion
2021-06-01

Outcome

Missed primary endpoint

registry analysis (superiority test); Doxycycline vs Placebo; p = 0.16; Wilcoxon (Mann-Whitney); note: Threshold p\<0.0167 NCT04167085 ↗

registry analysis (superiority test); Doxycycline vs Placebo; p = 0.05; Wilcoxon (Mann-Whitney); note: Threshold p\<0.0167 NCT04167085 ↗

registry analysis (superiority test); Doxycycline vs Placebo; p = 0.19; Wilcoxon (Mann-Whitney); note: Threshold p\<0.0167 NCT04167085 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxycycline Small molecule 100 mg —

Indications

No indication recorded.