Trial · NCT01413958
Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1)
NCT01413958, Phase 3, Completed, Bayer; results first posted 2013-01-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1). Trials, record NCT01413958. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01413958
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1)
- NCT number
- NCT01413958
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 575 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Phenylephrine, Placebo, Loratadine
- First posted
- 2011-08-10
- Last updated
- 2015-03-11
- Results first posted
- 2013-01-29
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Daily Reflective Nasal Congestion Score | Baseline and Days 1-7 | The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period. |
| Secondary | Mean Change From Baseline in the Morning Reflective Symptom Assessment Score | Baseline and Days 1-7 | The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily morning nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period. |
| Secondary | Mean Change From Baseline in the Evening Reflective Symptom Assessment Score | Baseline and Days 1-7 | The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily evening nasal congestion score was calculated from data captured daily (evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period. |
| Secondary | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score | Baseline and Days 1-7 | The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score over the entire treatment period. |
| Secondary | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Baseline and Day 1, 2, 3, 4, 5, 6, and 7 | The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period. |
| Secondary | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Baseline and Day 1, 2, 3, 4, 5, 6, 7 | The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The daily nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period. |
| Secondary | Time to Maximal Phenylephrine Effect | Baseline up to Day 7 | The time to maximal phenylephrine effect was defined as the earliest time that the nasal congestion symptom score in the Phenylephrine treatment group demonstrated the greatest numerical difference from the Placebo treatment group in change from baseline. The mean change from baseline scores for a Phenylephrine treatment arm and for the Placebo treatment arm at each timepoint of the treatment period (Day 1 morning, Day 1 evening, etc) was calculated. The difference between the Phenylephrine treatment arm and Placebo treatment arm mean at each timepoint of the treatment period was calculated. The time to maximal phenylephrine effect was the first timepoint at which the difference between the Phenylephrine treatment arm and the Placebo treatment arm was greatest. The results for the Placebo treatment arm are not presented as the result of this outcome measure is only relevant for the Phenylephrine treatment group. |
| Secondary | Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score | Baseline and Day 7 | The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms). The average of individual instantaneous nasal scores was reported as the daily instantaneous nasal congestion score over the entire treatment period. |
| Secondary | Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score | Baseline and Days 1-7 | The instantaneous assessment is a self-evaluation of the symptom severity at the moment of the assessment prior to the next dose. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = worst symptoms. The average of individual morning instantaneous nasal scores was reported as the daily morning instantaneous nasal congestion score over the entire treatment period. |
| Secondary | Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Baseline and Day 2, 3, 4, 5, 6, and 7 | The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured daily (morning) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = best and 3 = severe symptoms. The average of individual reflective nasal scores were reported as the daily reflective nasal congestion score for each day of the treatment period. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in Daily Reflective Nasal Congestion Score | Baseline and Days 1-7 | Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286. | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the Morning Reflective Symptom Assessment Score | Baseline and Days 1-7 | Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286. | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the Evening Reflective Symptom Assessment Score | Baseline and Days 1-7 | Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286. | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score | Baseline and Days 1-7 | Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286. | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day | Baseline and Day 1, 2, 3, 4, 5, 6, and 7 | Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). For the Phenylephrine Group, there were 287 evaluable participants on Day 1 and 288 on Days 2 - 7. For Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 4, 5, 6, and 285 on Day 7. | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day | Baseline and Day 1, 2, 3, 4, 5, 6, 7 | The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 287 evaluable participants on Day 1 and 288 on Day 2 - 7. For the Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 4, 5, 6 and 285 on Day 7. | Scores on a scale | MEAN |
| SECONDARY | Time to Maximal Phenylephrine Effect | Baseline up to Day 7 | All participants in the intent-to-treat population (all randomized participants who received at least 1 tablet of study medication). | Days | NUMBER |
| SECONDARY | Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score | Baseline and Day 7 | Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and at Day 7 was 285. | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score | Baseline and Days 1-7 | Efficacy analysis was performed on the intent-to-treat population (all randomized participants who received at least 1 dose of study medication). Number of participants evaluable in the placebo group at baseline was 287 and for the treatment period was 286. | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. | Baseline and Day 2, 3, 4, 5, 6, and 7 | The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 2 - 5 and 287 on Day 6. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 2, 5, and 6 and 285 on Days 3, 4, and 7. | Scores on a scale | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group121
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Daily Reflective Nasal Congestion Score | Phenylephrine | Baseline | 2.357 | Standard Deviation 0.5203 | Scores on a scale |
| Mean Change From Baseline in Daily Reflective Nasal Congestion Score | Placebo | Baseline | 2.271 | Standard Deviation 0.5586 | Scores on a scale |
| Mean Change From Baseline in Daily Reflective Nasal Congestion Score | Phenylephrine | Change from Baseline for Entire Treatment Period | -0.394 | Standard Deviation 0.4880 | Scores on a scale |
| Mean Change From Baseline in Daily Reflective Nasal Congestion Score | Placebo | Change from Baseline for Entire Treatment Period | -0.412 | Standard Deviation 0.5383 | Scores on a scale |
| Mean Change From Baseline in the Morning Reflective Symptom Assessment Score | Phenylephrine | Baseline | 2.357 | Standard Deviation 0.5480 | Scores on a scale |
| Mean Change From Baseline in the Morning Reflective Symptom Assessment Score | Placebo | Baseline | 2.274 | Standard Deviation 0.5801 | Scores on a scale |
| Mean Change From Baseline in the Morning Reflective Symptom Assessment Score | Phenylephrine | Entire Treatment Period | -0.403 | Standard Deviation 0.5420 | Scores on a scale |
| Mean Change From Baseline in the Morning Reflective Symptom Assessment Score | Placebo | Entire Treatment Period | -0.425 | Standard Deviation 0.5868 | Scores on a scale |
| Mean Change From Baseline in the Evening Reflective Symptom Assessment Score | Phenylephrine | Baseline | 2.353 | Standard Deviation 0.5470 | Scores on a scale |
| Mean Change From Baseline in the Evening Reflective Symptom Assessment Score | Placebo | Baseline | 2.261 | Standard Deviation 0.5932 | Scores on a scale |
1 to 10 of 121Source ClinicalTrials.gov
See all 121 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phenylephrine | 288 | |
| Overall Study | STARTED | Placebo | 287 | |
| Overall Study | COMPLETED | Phenylephrine | 288 | |
| Overall Study | COMPLETED | Placebo | 286 | |
| Overall Study | NOT COMPLETED | Phenylephrine | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phenylephrine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Phenylephrine | 0 | 288 |
| Total, other adverse events | Placebo | 0 | 287 |
| Total, serious adverse events | Phenylephrine | 0 | 288 |
| Total, serious adverse events | Placebo | 0 | 287 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26560899 | DERIVED |
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 |
|---|
| Phenylephrine 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.
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