Trial · NCT01386125
A Study of the Effectiveness and Safety of Mometasone Furoate Nasal Spray (MFNS, SCH 032088) for the Treatment of Nasal Polyps (P05604)
NCT01386125, Phase 3, Completed, Organon and Co; results first posted 2013-12-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of the Effectiveness and Safety of Mometasone Furoate Nasal Spray (MFNS, SCH 032088) for the Treatment of Nasal Polyps (P05604). Trials, record NCT01386125. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01386125
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Effectiveness and Safety of Mometasone Furoate Nasal Spray (MFNS, SCH 032088) for the Treatment of Nasal Polyps (P05604)
- NCT number
- NCT01386125
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 748 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Nasal Polyps
- Interventions
- Mometasone Furoate Nasal Spray (MFNS), Placebo for MFNS
- First posted
- 2011-06-30
- Last updated
- 2024-05-21
- Results first posted
- 2013-12-19
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 Congestion/Obstruction Score | Baseline and Weeks 1-4 | At Baseline, the Investigator and participant jointly evaluated the signs and symptoms of congestion/obstruction. After Baseline, participants scored the signs and symptoms of congestion/obstruction every morning immediately prior to dosing using a morning instantaneous congestion/obstruction score. This score reflected the participant's condition at that time (instantaneous) and ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3= severe), with a lower score indicating less congestion/obstruction. Congestion/obstruction scores were averaged over Weeks 1-4 of the treatment period. Data are compared using Least Square (LS) Means. LS Mean Change from Baseline = LS Mean Score averaged over Weeks 1-4 - LS Mean Score for Baseline. |
| Primary | Change From Baseline in Total Polyp Size Score | Baseline and Week 16 | An endoscopic nasal examination was performed by the Investigator. Bilateral nasal polyps were scored as follows for each notril (left and right): 0=no polyps, 1=polyps in middle meatus not reaching below inferior border of middle turbinate, 2=polyps reaching below inferior border of middle turbinate but not inferior border of inferior turbinate, 3=large polyps reaching to or below the lower borders of the inferior turbinate or polyps medial to the middle turbinate. Total polyp size score ranged from 0 to 6 (scored 0 to 3 for each nostril), with a lower score indicating smaller-sized polyps. LS Mean Change from Baseline = LS Mean Score for Week 16 - LS Mean Score for Baseline. |
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 Congestion/Obstruction Score | Baseline and Weeks 1-4 | The Full Analysis Set (FAS) population consisted of all randomized participants who received at least one dose of study treatment and who had a baseline and at least one post-baseline efficacy assessment. | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Total Polyp Size Score | Baseline and Week 16 | The FAS population consisted of all randomized participants who received at least one dose of study treatment and who had a baseline and at least one post-baseline efficacy assessment. | 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 Congestion/Obstruction Score | MFNS | -0.56 | Standard Error 0.03 | score on a scale | |
| Change From Baseline in Congestion/Obstruction Score | Placebo | -0.42 | Standard Error 0.03 | score on a scale | |
| Change From Baseline in Total Polyp Size Score | MFNS | -0.76 | Standard Error 0.05 | score on a scale | |
| Change From Baseline in Total Polyp Size Score | Placebo | -0.45 | Standard Error 0.05 | 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 | Mometasone Furoate Nasal Spray (MFNS) | 375 | |
| Overall Study | STARTED | Placebo | 373 | |
| Overall Study | COMPLETED | Mometasone Furoate Nasal Spray (MFNS) | 350 | |
| Overall Study | COMPLETED | Placebo | 336 | |
| Overall Study | NOT COMPLETED | Mometasone Furoate Nasal Spray (MFNS) | 25 | |
| Overall Study | NOT COMPLETED | Placebo | 37 |
Source ClinicalTrials.gov
Adverse events10
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 |
|---|---|---|---|---|---|---|
| serious | Ventricular extrasystoles | Cardiac disorders | MFNS | 0 | 375 | 0 |
| serious | Ventricular extrasystoles | Cardiac disorders | Placebo | 1 | 373 | 1 |
| serious | Fracture | Injury, poisoning and procedural complications | MFNS | 0 | 375 | 0 |
| serious | Fracture | Injury, poisoning and procedural complications | Placebo | 1 | 373 | 1 |
| serious | Diabetes mellitus | Metabolism and nutrition disorders | MFNS | 0 | 375 | 0 |
| serious | Diabetes mellitus | Metabolism and nutrition disorders | Placebo | 1 | 373 | 1 |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | MFNS | 1 | 375 | 1 |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 373 | 0 |
| serious | Nasal polypectomy | Surgical and medical procedures | MFNS | 1 | 375 | 1 |
| serious | Nasal polypectomy | Surgical and medical procedures | Placebo | 0 | 373 | 0 |
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 | 0 | 375 |
| Total, other adverse events | Placebo | 0 | 373 |
| Total, serious adverse events | MFNS | 2 | 375 |
| Total, serious adverse events | Placebo | 3 | 373 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26575524 | 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 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/NCT01386125
GET https://conductscience.org/api/trials/v1/NCT01386125/registered