Trial Outcomes & Findings for Study of Nasonex® in Improving Sleep Disturbances Related to Perennial Allergic Rhinitis (Study P04909)(TERMINATED) (NCT NCT00491374)
NCT ID: NCT00491374
Last Updated: 2009-01-06
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Results posted on
2009-01-06
Participant Flow
No subject fulfilled the requirements for randomized assignment of treatment; thus, no subject was assigned an intervention, and no subject was treated. The trial was terminated.
Participant milestones
| Measure |
Placebo
|
Mometasone Furoate Nasal Spray
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Nasonex® in Improving Sleep Disturbances Related to Perennial Allergic Rhinitis (Study P04909)(TERMINATED)
Baseline characteristics by cohort
| Measure |
Placebo
|
Mometasone Furoate Nasal Spray
|
Total
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Any Age
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Sex/Gender, Customized
Either Sex
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Population: The primary outcome measure could not be assessed because no subject received randomized treatment assignment, or any treatment. The study was terminated.
Outcome measures
| Measure |
Placebo
|
Mometasone Furoate Nasal Spray
|
|---|---|---|
|
The Change From Baseline in the Number of Apnea-hypopnea Episodes Per Hour (Apnea-hypopnea Index (AHI)
|
0 (NUMBER)
|
0 (NUMBER)
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mometasone Furoate Nasal Spray
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER