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Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction

Study acronym: DEMECA
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later May 30, 2026 → Nov 30, 2026
See other at-risk trials from Laboratoires Gilbert

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 30, 2026 to Nov 30, 2026
    • Study completion pushed from Jun 7, 2026 to Dec 7, 2026
    v4
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Oct 2025 to May 30, 2026
    • Study sites: 1 to 3
    • Study completion date: Oct 2025 to Jun 7, 2026
    • Start date changed from estimate of Sep 2024 to Oct 22, 2024
  3. Secondary endpoints revised (18)
    • Site contact updated
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 post-market clinical investigation is to assess the performance and the safety of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert. The study will evaluate the results of the spray on the acute rhinitis with nasal obstruction over a 7 days period.
Trial Details
NCT Number NCT06580210
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 114 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov