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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Completed
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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