Trial Outcomes & Findings for Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED) (NCT NCT00976209)
NCT ID: NCT00976209
Last Updated: 2015-03-11
Results Overview
Preference was calculated based on total participants that completed the study. Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints: Which product, if any, did you prefer for the relief of nasal congestion? The possible answers were: * I preferred the relief of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet) * I preferred the relief of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet) or • I did not have a preference
COMPLETED
PHASE3
331 participants
Visit 6 (Period 2, Day 4)
2015-03-11
Participant Flow
Participant milestones
| Measure |
Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR
Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride (HCl) 30 mg Extended Release (ER) tablets every 12 hours, twice daily, for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine HCl 10 mg Immediate Release (IR) tablets, every 4 hours (no more than 6 times daily) for 3 days.
|
Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER
Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride 10 mg Immediate Release tablets, every 4 hours (no more than 6 times daily) for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine Hydrochloride 30 mg Extended Release tablets every 12 hours, twice daily, for 3 days.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
165
|
166
|
|
Treatment Period 1
COMPLETED
|
162
|
165
|
|
Treatment Period 1
NOT COMPLETED
|
3
|
1
|
|
Wash-out Period
STARTED
|
162
|
165
|
|
Wash-out Period
COMPLETED
|
158
|
163
|
|
Wash-out Period
NOT COMPLETED
|
4
|
2
|
|
Treatment Period 2
STARTED
|
158
|
163
|
|
Treatment Period 2
COMPLETED
|
158
|
161
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR
Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride (HCl) 30 mg Extended Release (ER) tablets every 12 hours, twice daily, for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine HCl 10 mg Immediate Release (IR) tablets, every 4 hours (no more than 6 times daily) for 3 days.
|
Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER
Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride 10 mg Immediate Release tablets, every 4 hours (no more than 6 times daily) for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine Hydrochloride 30 mg Extended Release tablets every 12 hours, twice daily, for 3 days.
|
|---|---|---|
|
Treatment Period 1
Protocol Violation
|
1
|
0
|
|
Treatment Period 1
Lost to Follow-up
|
2
|
0
|
|
Treatment Period 1
Other
|
0
|
1
|
|
Wash-out Period
Adverse Event
|
1
|
2
|
|
Wash-out Period
Lost to Follow-up
|
1
|
0
|
|
Wash-out Period
Protocol Violation
|
1
|
0
|
|
Wash-out Period
Other
|
1
|
0
|
|
Treatment Period 2
Withdrawal by Subject
|
0
|
1
|
|
Treatment Period 2
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR
n=165 Participants
Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride (HCl) 30 mg Extended Release (ER) tablets every 12 hours, twice daily, for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine HCl 10 mg Immediate Release (IR) tablets, every 4 hours (no more than 6 times daily) for 3 days.
|
Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER
n=166 Participants
Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride 10 mg Immediate Release tablets, every 4 hours (no more than 6 times daily) for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine Hydrochloride 30 mg Extended Release tablets every 12 hours, twice daily, for 3 days.
|
Total
n=331 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 11.07 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 11.45 • n=7 Participants
|
39.5 years
STANDARD_DEVIATION 11.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 6 (Period 2, Day 4)Population: A total of 319 of 331 subjects who completed both treatment periods provided a response to the primary endpoint, and hence were included in the Modified Intent-to-Treat (MITT) population.
Preference was calculated based on total participants that completed the study. Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints: Which product, if any, did you prefer for the relief of nasal congestion? The possible answers were: * I preferred the relief of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet) * I preferred the relief of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet) or • I did not have a preference
Outcome measures
| Measure |
All Participants
n=319 Participants
Participants received Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days and Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days in a cross-over fashion. A 3 day (+/- 1 day) washout period separated the two treatment periods.
|
|---|---|
|
Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion
No Preference
|
17 Percentage of participants
|
|
Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion
Phenylephrine HCL ER, 30 mg
|
55 Percentage of participants
|
|
Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion
Phenylephrine HCl IR, 10 mg
|
28 Percentage of participants
|
SECONDARY outcome
Timeframe: Visit 6 (Period 2, Day 4)Population: A total of 319 of 331 subjects who completed both treatment periods provided a response to the primary endpoint, and hence were included in the Modified Intent-to-Treat (MITT) population.
Convenience was calculated based on total participants that completed the study. Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints: Secondary Endpoint Which product, if any, was more convenient? The possible answers were: * I preferred the convenience of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet) * I preferred the convenience of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet) or • I did not have a preference
Outcome measures
| Measure |
All Participants
n=319 Participants
Participants received Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days and Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days in a cross-over fashion. A 3 day (+/- 1 day) washout period separated the two treatment periods.
|
|---|---|
|
Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets
Phenylephrine HCL IR, 10 mg
|
6 Percentage of participants
|
|
Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets
No Preference
|
6 Percentage of participants
|
|
Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets
Phenylephrine HCL ER, 30 mg
|
88 Percentage of participants
|
Adverse Events
Phenylephrine HCl ER, 30 mg
Phenylephrine HCl IR, 10 mg
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.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place