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NCT01122849 · ClinicalTrials.gov registry record · Phase 2

Exploratory Subjective Sleep Study of a Prototype Nasal Dilator

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
61
Enrollment target

NCT01122849: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT01122849 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01122849, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
61 participants
Enrollment target

Study Summary

The purpose of this exploratory study is to evaluate the subjective measures of congestion and sleep quality in subjects who suffer from chronic nasal congestion and report trouble with their sleep.

Primary Outcome

The PIRS questionnaire had 3 sections (Section A \[Q1 to Q12\], Section B \[Q13 to 16\] and Section C \[Q17 to Q20\]). The following questions were asked from Section A : 1. One or more awakenings after getting to sleep and 3 Sleep that does not fully refresh you, and Section C: 17 Your sleep quality compared to most people and 18 Your satisfaction with your sleep. Section A question were scored as follows: 0= Not at all bothered, 1= slightly bothered, 2=moderately bothered, and 3= severely both

Interventions

  • DEVICE Marketed Nasal Strip
  • DEVICE Prototype Nasal Dilator
  • DEVICE Placebo Nasal Strip

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2009-10-01
Est. Completion 2010-02-01
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT01122849 record still lists

NCT01122849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).

The record links to 0 conditions, and to 3 interventions - of which Marketed Nasal Strip is the first listed.

NCT01122849 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01122849 about?

NCT01122849 is a clinical study titled "Exploratory Subjective Sleep Study of a Prototype Nasal Dilator". The purpose of this exploratory study is to evaluate the subjective measures of congestion and sleep quality in subjects who suffer from chronic nasal congestion and report trouble with their sleep.

What is the current status of trial NCT01122849?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2009-10-01. Estimated completion is 2010-02-01.

What interventions are being tested in trial NCT01122849?

The interventions under investigation include: Marketed Nasal Strip (DEVICE), Prototype Nasal Dilator (DEVICE), Placebo Nasal Strip (DEVICE).

Who is sponsoring clinical trial NCT01122849?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01122849's enrollment target sits among peer trials

61 1026th of 2000 higher than 974 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01122849, the US trial registry maintained by the National Library of Medicine. NCT01122849 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.