Trial Outcomes & Findings for Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1) (NCT NCT01413958)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

575 participants

Primary outcome timeframe

Baseline and Days 1-7

Results posted on

2015-03-11

Participant Flow

29 centers in the United States; Study Period: August 2011 to October 2011

Participant milestones

Participant milestones
Measure	Phenylephrine Phenylephrine hydrochloride, 30 mg extended-release tablets, one tablet every 12 hours for 7 days	Placebo Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Overall Study STARTED	288	287
Overall Study COMPLETED	288	286
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Phenylephrine Phenylephrine hydrochloride, 30 mg extended-release tablets, one tablet every 12 hours for 7 days	Placebo Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Effects of Phenylephrine Extended-Release Tablets on Allergy-Related Nasal Congestion (P08498 AM1)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phenylephrine n=288 Participants Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days	Placebo n=287 Participants Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days	Total n=575 Participants Total of all reporting groups
Age, Continuous	40.1 years STANDARD_DEVIATION 11.64 • n=93 Participants	40.1 years STANDARD_DEVIATION 11.62 • n=4 Participants	40.1 years STANDARD_DEVIATION 11.62 • n=27 Participants
Sex: Female, Male Female	176 Participants n=93 Participants	177 Participants n=4 Participants	353 Participants n=27 Participants
Sex: Female, Male Male	112 Participants n=93 Participants	110 Participants n=4 Participants	222 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and Days 1-7

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Phenylephrine n=288 Participants Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days	Placebo n=287 Participants Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Mean Change From Baseline in Daily Reflective Nasal Congestion Score Baseline	2.357 Scores on a scale Standard Deviation 0.5203	2.271 Scores on a scale Standard Deviation 0.5586
Mean Change From Baseline in Daily Reflective Nasal Congestion Score Change from Baseline for Entire Treatment Period	-0.394 Scores on a scale Standard Deviation 0.4880	-0.412 Scores on a scale Standard Deviation 0.5383

SECONDARY outcome

Timeframe: Baseline and Days 1-7

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Phenylephrine n=288 Participants Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days	Placebo n=287 Participants Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Mean Change From Baseline in the Morning Reflective Symptom Assessment Score Baseline	2.357 Scores on a scale Standard Deviation 0.5480	2.274 Scores on a scale Standard Deviation 0.5801
Mean Change From Baseline in the Morning Reflective Symptom Assessment Score Entire Treatment Period	-0.403 Scores on a scale Standard Deviation 0.5420	-0.425 Scores on a scale Standard Deviation 0.5868

SECONDARY outcome

Timeframe: Baseline and Days 1-7

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Phenylephrine n=288 Participants Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days	Placebo n=287 Participants Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Mean Change From Baseline in the Evening Reflective Symptom Assessment Score Baseline	2.353 Scores on a scale Standard Deviation 0.5470	2.261 Scores on a scale Standard Deviation 0.5932
Mean Change From Baseline in the Evening Reflective Symptom Assessment Score Entire Treatment Period	-0.403 Scores on a scale Standard Deviation 0.5424	-0.424 Scores on a scale Standard Deviation 0.5894

SECONDARY outcome

Timeframe: Baseline and Days 1-7

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Phenylephrine n=288 Participants Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days	Placebo n=286 Participants Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Entire Treatment Period	-0.311 Scores on a scale Standard Deviation 0.4663	-0.366 Scores on a scale Standard Deviation 0.5265
Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Baseline	2.299 Scores on a scale Standard Deviation 0.5250	2.225 Scores on a scale Standard Deviation 0.5498

SECONDARY outcome

Timeframe: Baseline and Day 1, 2, 3, 4, 5, 6, and 7

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Phenylephrine n=288 Participants Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days	Placebo n=287 Participants Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day Baseline	2.357 Scores on a scale Standard Deviation 0.5203	2.271 Scores on a scale Standard Deviation 0.5586
Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day Day 1	-0.261 Scores on a scale Standard Deviation 0.5545	-0.197 Scores on a scale Standard Deviation 0.6335
Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day Day 2	-0.302 Scores on a scale Standard Deviation 0.5248	-0.321 Scores on a scale Standard Deviation 0.5721
Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day Day 3	-0.401 Scores on a scale Standard Deviation 0.6100	-0.396 Scores on a scale Standard Deviation 0.6227
Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day Day 4	-0.395 Scores on a scale Standard Deviation 0.6234	-0.492 Scores on a scale Standard Deviation 0.6942
Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day Day 5	-0.465 Scores on a scale Standard Deviation 0.6475	-0.478 Scores on a scale Standard Deviation 0.6977
Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day Day 6	-0.461 Scores on a scale Standard Deviation 0.6918	-0.488 Scores on a scale Standard Deviation 0.7444
Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day Day 7	-0.474 Scores on a scale Standard Deviation 0.7116	-0.512 Scores on a scale Standard Deviation 0.7903

SECONDARY outcome

Timeframe: Baseline and Day 1, 2, 3, 4, 5, 6, 7

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Phenylephrine n=288 Participants Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days	Placebo n=287 Participants Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day Baseline	2.299 Scores on a scale Standard Deviation 0.5250	2.225 Scores on a scale Standard Deviation 0.5498
Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day Day 1	-0.192 Scores on a scale Standard Deviation 0.5809	-0.200 Scores on a scale Standard Deviation 0.6451
Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day Day 2	-0.255 Scores on a scale Standard Deviation 0.5046	-0.256 Scores on a scale Standard Deviation 0.5472
Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day Day 3	-0.307 Scores on a scale Standard Deviation 0.6206	-0.373 Scores on a scale Standard Deviation 0.6548
Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day Day 4	-0.351 Scores on a scale Standard Deviation 0.6133	-0.406 Scores on a scale Standard Deviation 0.6881
Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day Day 5	-0.359 Scores on a scale Standard Deviation 0.6432	-0.406 Scores on a scale Standard Deviation 0.6632
Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day Day 6	-0.361 Scores on a scale Standard Deviation 0.6582	-0.443 Scores on a scale Standard Deviation 0.7336
Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day Day 7	-0.352 Scores on a scale Standard Deviation 0.6698	-0.476 Scores on a scale Standard Deviation 0.7829

SECONDARY outcome

Timeframe: Baseline up to Day 7

Population: All participants in the intent-to-treat population (all randomized participants who received at least 1 tablet of study medication).

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.

Outcome measures

Outcome measures
Measure	Phenylephrine n=288 Participants Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days	Placebo Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Time to Maximal Phenylephrine Effect	0.5 Days	—

SECONDARY outcome

Timeframe: Baseline and Day 7

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Phenylephrine n=288 Participants Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days	Placebo n=287 Participants Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Baseline	2.299 Scores on a scale Standard Deviation 0.5250	2.225 Scores on a scale Standard Deviation 0.5498
Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Day 7	-0.352 Scores on a scale Standard Deviation 0.6698	-0.476 Scores on a scale Standard Deviation 0.7829

SECONDARY outcome

Timeframe: Baseline and Days 1-7

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Phenylephrine n=288 Participants Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days	Placebo n=287 Participants Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score Baseline	2.313 Scores on a scale Standard Deviation 0.5518	2.264 Scores on a scale Standard Deviation 0.5816
Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score Entire Treatment Period	-0.295 Scores on a scale Standard Deviation 0.5088	-0.363 Scores on a scale Standard Deviation 0.5815

SECONDARY outcome

Timeframe: Baseline and Day 2, 3, 4, 5, 6, and 7

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Phenylephrine n=288 Participants Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days	Placebo n=287 Participants Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. Baseline	2.357 Scores on a scale Standard Deviation 0.5480	2.274 Scores on a scale Standard Deviation 0.5801
Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. Day 2	-0.263 Scores on a scale Standard Deviation 0.5769	-0.273 Scores on a scale Standard Deviation 0.6685
Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. Day 3	-0.402 Scores on a scale Standard Deviation 0.6723	-0.380 Scores on a scale Standard Deviation 0.6932
Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. Day 4	-0.367 Scores on a scale Standard Deviation 0.7147	-0.469 Scores on a scale Standard Deviation 0.7482
Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. Day 5	-0.451 Scores on a scale Standard Deviation 0.7214	-0.480 Scores on a scale Standard Deviation 0.7631
Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. Day 6	-0.456 Scores on a scale Standard Deviation 0.7425	-0.462 Scores on a scale Standard Deviation 0.8294
Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period. Day 7	-0.478 Scores on a scale Standard Deviation 0.7830	-0.489 Scores on a scale Standard Deviation 0.8515

SECONDARY outcome

Timeframe: Baseline and Day 1, 2, 3, 4, 5, 6, and 7

Population: The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Day 5, 287 on Days 1, 3, 4, 6 and 286 on Day 2. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 2, 5, 6, 285 on Days 3 and 7 and 284 on Day 4.

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 (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.

Outcome measures

Outcome measures
Measure	Phenylephrine n=288 Participants Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days	Placebo n=287 Participants Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period Baseline	2.353 Scores on a scale Standard Deviation 0.5470	2.261 Scores on a scale Standard Deviation 0.5932
Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period Day 1	-0.257 Scores on a scale Standard Deviation 0.5850	-0.187 Scores on a scale Standard Deviation 0.6583
Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period Day 2	-0.343 Scores on a scale Standard Deviation 0.6732	-0.362 Scores on a scale Standard Deviation 0.6729
Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period Day 3	-0.402 Scores on a scale Standard Deviation 0.7200	-0.404 Scores on a scale Standard Deviation 0.7336
Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period Day 4	-0.420 Scores on a scale Standard Deviation 0.7294	-0.511 Scores on a scale Standard Deviation 0.8180
Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period Day 5	-0.475 Scores on a scale Standard Deviation 0.7154	-0.470 Scores on a scale Standard Deviation 0.7997
Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period Day 6	-0.463 Scores on a scale Standard Deviation 0.7593	-0.509 Scores on a scale Standard Deviation 0.8143
Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period Day 7	-0.464 Scores on a scale Standard Deviation 0.7813	-0.528 Scores on a scale Standard Deviation 0.8802

SECONDARY outcome

Timeframe: Baseline and Day 2, 3, 4, 5, 6, and 7

Population: The Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 1, 2, 3, 4, 5, 7 and 286 evaluable participants at Day 6. For the Placebo Group, there were 287 evaluable participants on Day 1, 286 on Days 3, 5, 6 and 285 on Days 2, 4, 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 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 instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.

Outcome measures

Outcome measures
Measure	Phenylephrine n=288 Participants Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days	Placebo n=287 Participants Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period Baseline	2.313 Scores on a scale Standard Deviation 0.5518	2.264 Scores on a scale Standard Deviation 0.5816
Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period Day 2	-0.188 Scores on a scale Standard Deviation 0.5680	-0.185 Scores on a scale Standard Deviation 0.6511
Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period Day 3	-0.285 Scores on a scale Standard Deviation 0.6888	-0.373 Scores on a scale Standard Deviation 0.7389
Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period Day 4	-0.326 Scores on a scale Standard Deviation 0.7035	-0.383 Scores on a scale Standard Deviation 0.7680
Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period Day 5	-0.326 Scores on a scale Standard Deviation 0.7201	-0.387 Scores on a scale Standard Deviation 0.7617
Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period Day 6	-0.327 Scores on a scale Standard Deviation 0.7128	-0.394 Scores on a scale Standard Deviation 0.8314
Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period Day 7	-0.319 Scores on a scale Standard Deviation 0.7488	-0.462 Scores on a scale Standard Deviation 0.8618

SECONDARY outcome

Timeframe: Baseline and Day 1, 2, 3, 4, 5, 6, and 7

Population: Intent-To-Treat Population was used in this analysis. For the Phenylephrine Group, there were 288 evaluable participants on Days 5 and 7, 287 on Days 1, 3, 4 and 286 on Days 2 and 6. For the Placebo Group, there were 286 evaluable participants on Days 1, 2, 3, 5, 6 and 285 on Day 7 and 284 on Day 4.

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 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 instantaneous nasal scores was reported as the daily instantaneous nasal congestion score for each day of the treatment period.

Outcome measures

Outcome measures
Measure	Phenylephrine n=288 Participants Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days	Placebo n=287 Participants Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. Baseline	2.300 Scores on a scale Standard Deviation 0.5612	2.189 Scores on a scale Standard Deviation 0.5878
Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. Day 1	-0.193 Scores on a scale Standard Deviation 0.5888	-0.164 Scores on a scale Standard Deviation 0.6415
Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. Day 2	-0.344 Scores on a scale Standard Deviation 0.6768	-0.332 Scores on a scale Standard Deviation 0.7020
Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. Day 3	-0.349 Scores on a scale Standard Deviation 0.7591	-0.378 Scores on a scale Standard Deviation 0.7773
Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. Day 4	-0.395 Scores on a scale Standard Deviation 0.7529	-0.434 Scores on a scale Standard Deviation 0.8079
Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. Day 5	-0.408 Scores on a scale Standard Deviation 0.7558	-0.430 Scores on a scale Standard Deviation 0.7714
Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. Day 6	-0.424 Scores on a scale Standard Deviation 0.7584	-0.497 Scores on a scale Standard Deviation 0.8122
Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period. Day 7	-0.401 Scores on a scale Standard Deviation 0.7865	-0.495 Scores on a scale Standard Deviation 0.8645

SECONDARY outcome

Timeframe: Up to Day 8

Population: The Intent-To-Treat Population was used in this analysis. There were 285 evaluable participants for the Placebo Group at Day 8.

The RQLQ is a disease-specific quality of life questionnaire developed to measure the physical, emotional, and social problems in adults with rhinoconjunctivitis. Questions were divided into 7 domains: sleep (3 questions), non-hay fever symptoms (7 questions), practical problems (3 questions), nasal symptoms (4 questions), eye symptoms (4 questions), and activities (3 questions), and emotions (4 questions). Individual items within the RQLQ are equally weighted. The questionnaire is analyzed directly from the scores recorded and the results are expressed as the mean score for each of the domains (i.e., domain scores range from 0 to 6). Six represents the greatest impairment and 0 represents the least impairment. Overall quality of life score is the mean score for all domains.

Outcome measures

Outcome measures
Measure	Phenylephrine n=288 Participants Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days	Placebo n=287 Participants Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ) Baseline	3.6 Scores on a scale Standard Deviation 1.28	3.5 Scores on a scale Standard Deviation 1.28
Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ) Day 8	-0.8 Scores on a scale Standard Deviation 1.15	-0.9 Scores on a scale Standard Deviation 1.13

Adverse Events

Phenylephrine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER