Trial · NCT01135134
Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)
NCT01135134, Phase 3, Completed, Organon and Co; results first posted 2011-11-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332). Trials, record NCT01135134. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01135134
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)
- NCT number
- NCT01135134
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 333 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Rhinitis, Allergic, Perennial
- Interventions
- Mometasone furoate, Placebo
- First posted
- 2010-06-02
- Last updated
- 2024-05-28
- Results first posted
- 2011-11-03
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 the Total Nasal Symptom Score at 2 Weeks | Baseline and 2 weeks (or discontinuation) | Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. |
| Secondary | Change From Baseline in the Total Nasal Symptom Score at 1 Week | Baseline and 1 week | Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. |
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 the Total Nasal Symptom Score at 2 Weeks | Baseline and 2 weeks (or discontinuation) | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline in the Total Nasal Symptom Score at 1 Week | Baseline and 1 week | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Total Nasal Symptom Score at 2 Weeks | MFNS | -3.9850 | Standard Error 0.1633 | score on a scale | |
| Change From Baseline in the Total Nasal Symptom Score at 2 Weeks | Placebo | -1.9081 | Standard Error 0.2233 | score on a scale | |
| Change From Baseline in the Total Nasal Symptom Score at 1 Week | MFNS | -2.4686 | Standard Error 0.1441 | score on a scale | |
| Change From Baseline in the Total Nasal Symptom Score at 1 Week | Placebo | -1.1651 | Standard Error 0.1967 | score 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 | MFNS | 220 | |
| Overall Study | STARTED | Placebo | 113 | |
| Overall Study | COMPLETED | MFNS | 218 | |
| Overall Study | COMPLETED | Placebo | 112 | |
| Overall Study | NOT COMPLETED | MFNS | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
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 | Naspharyngitis | Infections and infestations | MFNS | 11 | 220 | 11 |
| other | Naspharyngitis | Infections and infestations | Placebo | 10 | 113 | 10 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | MFNS | 13 | 220 | 15 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Placebo | 11 | 113 | 16 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MFNS | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | MFNS | 24 | 220 |
| Total, other adverse events | Placebo | 19 | 113 |
| Total, serious adverse events | MFNS | 0 | 220 |
| Total, serious adverse events | Placebo | 0 | 113 |
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 |
|---|
| MFNS vs Placebo: 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/NCT01135134
GET https://conductscience.org/api/trials/v1/NCT01135134/registered