Last updated: 11/04/2018 05:40:48

A Multiple Use Tolerability study of a Breathe Right Nasal Strip Prototype

GSK study ID
B3560692
Clinicaltrials.gov ID
NCT01495494
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Multiple Use Tolerability study of a Breathe Right Nasal Strip Prototype
Trial description: This study evaluated the safety & tolerability of two Breathe Right nasal strip prototypes. Prototypes were produced as an improvement to the currently marketed product.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Dermal response score of the application site of the nasal strip

Timeframe: Baseline through 7 days

Secondary outcomes:

Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip

Timeframe: 7 days

Interventions:
  • Device: Marketed Nasal Strip
  • Device: Prototype Nasal Dilator
    • Enrollment:
    80
    Primary completion date:
    2009-30-11
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Healthy Subjects
    Product
    Breathe Right
    Collaborators
    Not applicable
    Study date(s)
    November 2009 to November 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Healthy subjects
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • Healthy subjects

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    Essex Testing Clinic, Inc
    Verona, NJ, United States, 07044
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    2009-30-11
    Actual study completion date
    2009-30-11

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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