Last updated: 11/04/2018 05:40:35

A multiple use tolerance study of six nasal strips

GSK study ID
B3560634
Clinicaltrials.gov ID
Not applicable
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 tolerance study of six nasal strips
Trial description: This is a skin tolerance study of six nasal strips to determine whether the strips are safe to use over multiple uses.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Change from baseline dermal response score of the application site of the nasal strip

Timeframe: baseline to 7 days

Secondary outcomes:

Subjective questionnaires regarding comfort, overnight adherence and ease of removal

Timeframe: up to 7 days

Interventions:
  • Device: Prototype nasal strip A 25/5
  • Device: Prototype nasal strip T 22/5
  • Device: Marketed nasal strip - clear
  • Device: Marketed nasal strip - Tan
  • Device: Prototype nasal strip T 25/5
  • Device: Prototype nasal strip A 22/5
    • Enrollment:
    244
    Primary completion date:
    Not applicable
    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)
    April 2009 to April 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2009-27-04

    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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