Trial · NCT00552110

Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500)

NCT00552110, Phase 2, Completed, Organon and Co; results first posted 2009-07-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500). Trials, record NCT00552110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00552110

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500)
NCT number: NCT00552110
Status: Completed
Phases: Phase 2
Enrollment: 707 participants, actual
Lead sponsor: Organon and Co
Conditions: Seasonal Allergic Rhinitis
Interventions: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY), OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY), mometasone furoate nasal spray (MFNS) once daily, oxymetazoline nasal spray (OXY) twice daily, Placebo
First posted: 2007-11-01
Last updated: 2024-05-14
Results first posted: 2009-07-08
Limitations and caveats: Subject symptom data were not collected during the post-treatment period. Thus, daily diary data for rebound congestion was not analyzed.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15	15 days of treatment	Subjects scored severity of rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing at the time of evaluation (NOW) using an ordinal scale from 0 = none to 3 = severe. Evaluations were performed daily in the morning (AM) and evening (PM). For each evaluation, individual symptom scores were summed to a TNSS, which was then averaged for a single score across the 15 day treatment period.
Primary	Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score	from baseline to hour 4 on Day 1	Subjects scored nasal congestion/stuffiness using an ordinal scale from 0 = none to 3 = severe. Baseline was the average of the scores assessed every 15 minutes for 1 hour prior to dosing on Day 1. After dosing on Day 1, congestion was scored every 15 minutes for the 1st hour and every 30 minutes for the next 3 hours. Area under the curve (AUC) was calculated using the trapezoid rule, then standardization achieved by dividing the calculation by 4 hours. Treatment comparisons were examined using the standardized AUC(0-4 hr) of the change from baseline to hour 4 on Day 1.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15	15 days of treatment	Intention to treat (ITT): all randomized subjects who had taken at least one dose of study drug	units on a scale	LEAST_SQUARES_MEAN
PRIMARY	Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score	from baseline to hour 4 on Day 1	Intention to treat: all randomized subjects who had taken at least one dose of study drug	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15	Combination1	-3.29	Standard Error 0.209	units on a scale
Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15	Combination3	-3.36	Standard Error 0.216	units on a scale
Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15	Mometasone	-2.97	Standard Error 0.213	units on a scale
Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15	Oxymetazoline	-2.44	Standard Error 0.215	units on a scale
Change From Baseline in AM/PM Instantaneous Total Nasal Symptom Score (NOW TNSS) Averaged Over Days 1 to 15	Placebo	-1.90	Standard Error 0.209	units on a scale
Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score	Combination1	-0.80	Standard Error 0.056	units on a scale
Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score	Combination3	-0.92	Standard Error 0.057	units on a scale
Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score	Mometasone	-0.63	Standard Error 0.057	units on a scale
Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score	Oxymetazoline	-1.06	Standard Error 0.057	units on a scale
Standardized Area Under the Curve From 0 to 4 Hours [AUC(0-4 hr)] of the Change From Baseline to Hour 4 on Day 1 in Nasal Congestion Score	Placebo	-0.57	Standard Error 0.056	units on a scale

Source ClinicalTrials.gov

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Combination1	146
Overall Study	STARTED	Combination3	139
Overall Study	STARTED	Mometasone	139
Overall Study	STARTED	Oxymetazoline	141
Overall Study	STARTED	Placebo	142
Overall Study	COMPLETED	Combination1	142
Overall Study	COMPLETED	Combination3	134
Overall Study	COMPLETED	Mometasone	137
Overall Study	COMPLETED	Oxymetazoline	133
Overall Study	COMPLETED	Placebo	133

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events15

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Combination1	7	145	9
other	Headache	Nervous system disorders	Combination3	5	139	5
other	Headache	Nervous system disorders	Mometasone	10	139	11
other	Headache	Nervous system disorders	Oxymetazoline	7	140	8
other	Headache	Nervous system disorders	Placebo	8	142	8
serious	Gastrooesophageal Reflux Disease	Gastrointestinal disorders	Combination1	0	145	0
serious	Gastrooesophageal Reflux Disease	Gastrointestinal disorders	Combination3	0	139	0
serious	Gastrooesophageal Reflux Disease	Gastrointestinal disorders	Mometasone	0	139	0
serious	Gastrooesophageal Reflux Disease	Gastrointestinal disorders	Oxymetazoline	0	140	0
serious	Gastrooesophageal Reflux Disease	Gastrointestinal disorders	Placebo	1	142	1

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Combination1
Total, all-cause mortality	Combination3
Total, all-cause mortality	Mometasone
Total, all-cause mortality	Oxymetazoline
Total, all-cause mortality	Placebo
Total, other adverse events	Combination1	7	145
Total, other adverse events	Combination3	5	139
Total, other adverse events	Mometasone	10	139
Total, other adverse events	Oxymetazoline	7	140
Total, other adverse events	Placebo	8	142

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23562197	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00552110

GET https://conductscience.org/api/trials/v1/NCT00552110/registered

API reference For AI assistants