Trial · NCT00358527
Mometasone Furoate on Sleep Disturbances in Subjects With Seasonal Allergic Rhinitis (Study P04608) (COMPLETED)
NCT00358527, Phase 4, Completed, Organon and Co; results first posted 2010-03-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mometasone Furoate on Sleep Disturbances in Subjects With Seasonal Allergic Rhinitis (Study P04608) (COMPLETED). Trials, record NCT00358527. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00358527
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mometasone Furoate on Sleep Disturbances in Subjects With Seasonal Allergic Rhinitis (Study P04608) (COMPLETED)
- NCT number
- NCT00358527
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 401 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Mometasone Furoate Nasal Spray (MFNS), Placebo
- First posted
- 2006-08-01
- Last updated
- 2022-02-08
- Results first posted
- 2010-03-11
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score. | Average of the last 7 days of treatment | The TNSS score included the sum of nasal congestion/stuffiness, rhinorrhea/nasal discharge, sneezing, and nasal itching, each scored on a scale of 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The TNSS score could range from 0 to 12. NOTE: Least square means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate. |
| Primary | Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit. | 29 days | Following Visit 2 (Screening), at Baseline, Day 15, and Day 29 visits, participants needed to complete the MOS-SS questionnaire with scores from 1 = all of the time to 6 = none of the time, according to their frequency of occurrence during the previous week. The analysis endpoint MOS-SS Sleep Problems Index II (SLP9) score was derived from MOS-SS questionnaire and scaled from 0 = none of the time to 100 = all of the time. NOTE: Least squares means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate. |
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 | Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score. | Average of the last 7 days of treatment | Modified Intent-to-Treat (MITT) Population: all randomized subjects with any post-baseline data and without concomitant medications that could significantly bias the co-primary endpoints. | Units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit. | 29 days | Modified Intent-to-Treat (MITT) Population: all randomized subjects with any post-baseline data and without concomitant medications that could significantly bias the co-primary endpoints. | Units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score. | Mometasone Furoate Nasal Spray | Change from Baseline in TNSS score | -3.77 | Standard Error 0.19 | Units on a scale |
| Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score. | Placebo Nasal Spray. | Change from Baseline in TNSS score | -3.07 | Standard Error 0.26 | Units on a scale |
| Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score. | Mometasone Furoate Nasal Spray | Baseline TNSS score | 9.10 | Standard Error 0.10 | Units on a scale |
| Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score. | Placebo Nasal Spray. | Baseline TNSS score | 9.12 | Standard Error 0.14 | Units on a scale |
| Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit. | Mometasone Furoate Nasal Spray | Change from baseline in SLP9 score | -26.1 | Standard Error 1.38 | Units on a scale |
| Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit. | Placebo Nasal Spray. | Change from baseline in SLP9 score | -25.8 | Standard Error 1.90 | Units on a scale |
| Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit. | Mometasone Furoate Nasal Spray | Baseline SLP9 Score | 68.6 | Standard Error 0.86 | Units on a scale |
| Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit. | Placebo Nasal Spray. | Baseline SLP9 Score | 69.2 | Standard Error 1.20 | Units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mometasone Furoate Nasal Spray | 267 | |
| Overall Study | STARTED | Placebo Nasal Spray. | 134 | |
| Overall Study | COMPLETED | Mometasone Furoate Nasal Spray | 254 | |
| Overall Study | COMPLETED | Placebo Nasal Spray. | 131 | |
| Overall Study | NOT COMPLETED | Mometasone Furoate Nasal Spray | 13 | |
| Overall Study | NOT COMPLETED | Placebo Nasal Spray. | 3 |
Source ClinicalTrials.gov
Adverse events4
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 | Mometasone Furoate Nasal Spray | 10 | 267 | 16 |
| other | Headache | Nervous system disorders | Placebo Nasal Spray. | 7 | 134 | 8 |
| serious | Food allergy | Immune system disorders | Mometasone Furoate Nasal Spray | 1 | 267 | 1 |
| serious | Food allergy | Immune system disorders | Placebo Nasal Spray. | 0 | 134 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mometasone Furoate Nasal Spray | ||
| Total, all-cause mortality | Placebo Nasal Spray. | ||
| Total, other adverse events | Mometasone Furoate Nasal Spray | 10 | 267 |
| Total, other adverse events | Placebo Nasal Spray. | 7 | 134 |
| Total, serious adverse events | Mometasone Furoate Nasal Spray | 1 | 267 |
| Total, serious adverse events | Placebo Nasal Spray. | 0 | 134 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Mometasone Furoate Nasal Spray vs Placebo Nasal Spray.: serious adverse events |
Source Trial comparisons
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.
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/NCT00358527
GET https://conductscience.org/api/trials/v1/NCT00358527/registered