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Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"

Study acronym: DEVALPO
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Apr 18, 2026 → Dec 31, 2026
See other at-risk trials from Laboratoires Gilbert

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Apr 18, 2026 to Dec 31, 2026
    • Study completion pushed from Jun 30, 2026 to Jan 8, 2027
    v6
  2. Primary completion date: Nov 30, 2024 to Apr 18, 2026v5 Show 6 more changesShow less
    • Study sites: 2 to 5
    • Study completion date: Nov 30, 2024 to Jun 30, 2026
    • Start date: May 31, 2023 to Jun 23, 2023
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 2 of 15 entries
    • Study title expanded, about 1 word
  3. Primary completion date: Oct 31, 2023 to Nov 30, 2024
    • Study completion date: Nov 15, 2023 to Nov 30, 2024
    v4
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 2
    • Primary completion date: Sep 1, 2023 to Oct 31, 2023
    • Study completion date: Sep 30, 2023 to Nov 15, 2023
    • Start date changed from estimate of Apr 1, 2023 to May 31, 2023
  5. Primary completion date: Nov 30, 2022 to Sep 1, 2023
    • Start date: Sep 1, 2022 to Apr 1, 2023
    • Study completion date: Dec 7, 2022 to Sep 30, 2023
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.
Trial Details
NCT Number NCT05494346
Lead Sponsor Laboratoires Gilbert
Collaborators: EVAMED
Conditions
(from sponsor)		 Acute Rhinitis, Nasal Obstruction, Rhinosinusitis, Rhinopharyngitis, Allergic Rhinitis
Related terms Common Cold, Nasal Obstruction, Nasopharyngitis, Rhinitis, Allergic, Rhinosinusitis
Enrollment 101 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov