Trial Outcomes & Findings for A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis (NCT NCT01048866)
NCT ID: NCT01048866
Last Updated: 2017-09-21
Results Overview
STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. The full range was -104412 (complete pain relief within 1 hour of dosing that lasts 24 hours) to 27588 (maximum pain within 1 hour lasting 24 hours) using the mean baseline STPIS. Participants with a last recorded time point \<21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose.
COMPLETED
PHASE3
198 participants
baseline (pre-dose), post-dose - hourly up to 24 hours
2017-09-21
Participant Flow
Three hundred and thirty-six patients were screened.
Participant milestones
| Measure |
Flurbiprofen 8.75 mg Lozenge
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
97
|
|
Overall Study
COMPLETED
|
97
|
92
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Flurbiprofen 8.75 mg Lozenge
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Other
|
1
|
1
|
Baseline Characteristics
A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis
Baseline characteristics by cohort
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=101 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=97 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.5 years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 11.17 • n=7 Participants
|
33.9 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
67 participants
n=5 Participants
|
67 participants
n=7 Participants
|
134 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-racial (no primary)
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other, not specified
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
16 participants
n=5 Participants
|
10 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or non-Latino
|
85 participants
n=5 Participants
|
87 participants
n=7 Participants
|
172 participants
n=5 Participants
|
|
Sore Throat Pain Intensity Scale (STPIS)
|
79.1 units on a scale
STANDARD_DEVIATION 8.09 • n=5 Participants
|
79.1 units on a scale
STANDARD_DEVIATION 8.37 • n=7 Participants
|
79.1 units on a scale
STANDARD_DEVIATION 8.21 • n=5 Participants
|
|
Difficulty Swallowing Scale (DSS)
|
77.9 units on a scale
STANDARD_DEVIATION 10.55 • n=5 Participants
|
78.2 units on a scale
STANDARD_DEVIATION 10.3 • n=7 Participants
|
78.0 units on a scale
STANDARD_DEVIATION 10.45 • n=5 Participants
|
|
Swollen Throat Scale (SwoTS)
|
76.0 units on a scale
STANDARD_DEVIATION 12.90 • n=5 Participants
|
76.0 units on a scale
STANDARD_DEVIATION 12.7 • n=7 Participants
|
76.0 units on a scale
STANDARD_DEVIATION 12.80 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline (pre-dose), post-dose - hourly up to 24 hoursPopulation: Intent to treat population of participants who took the first full dose of medication, and had STPIS values recorded \>= 21 hours post initial dose. Four participants (2 Flurbiprofen, 2 placebo) did not have sufficient 24 hour data to be included in the primary analysis of the primary endpoint.
STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. The full range was -104412 (complete pain relief within 1 hour of dosing that lasts 24 hours) to 27588 (maximum pain within 1 hour lasting 24 hours) using the mean baseline STPIS. Participants with a last recorded time point \<21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=99 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=95 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24)
|
-522.9 units on a scale
Standard Deviation 476.54
|
-326.5 units on a scale
Standard Deviation 386.83
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), Hours 1 and 2 post-dosePopulation: Intent to treat population of participants who took the first full dose of medication
DSS measures difficulty swallowing (dysphagia) using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and "Place a line on the scale that best characterizes how difficult it is to swallow now." A mark at 0-mm indicated not difficult and 100-mm indicated very difficult. Data are reported as the sum of the time-weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9360 (no difficulty swallowing within 1 hour of dosing that lasts 2 hours) to 2640 (maximum difficulty swallowing within 1 hour of dosing lasting 2 hours) using the baseline DSS value. Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=101 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=97 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline
|
-37.1 units on a scale
Standard Deviation 39.60
|
-18.1 units on a scale
Standard Deviation 29.43
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), hourly readings to 24 hours post-dosePopulation: Intent to treat population. Four participants (2 Flurbiprofen and 2 placebo) did not have DSS recorded after 21 hours and were not included in the analysis.
DSS measures difficulty swallowing (dysphagia) using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and "Place a line on the scale that best characterizes how difficult it is to swallow now." A mark at 0-mm indicated not difficult and 100-mm indicated very difficult. Data are reported as the sum of the time-weighted pain intensity differences from baseline until 24 hours post dose. The full range was -102960 (no difficulty swallowing within 1 hour of dosing that lasts 24 hours) to 29040 (maximum difficulty swallowing within 1 hour of dosing lasting 24 hours) using the baseline DSS value. Negative values indicate improvement in difficulty swallowing. Missing values of DSS with non-missing values at assessments before and after were calculated using linear interpolation.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=99 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=95 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline
|
-555.5 units on a scale
Standard Deviation 494.04
|
-379.4 units on a scale
Standard Deviation 397.66
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), hourly readings to 2 hours post-dosePopulation: Intent to treat population of participants who took the first full dose of medication
SwoTS measures how swollen a participant's throat felt using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and "Place a line on the scale that best characterizes how swollen your throat feels now." A mark at 0-mm indicated not swollen and 100-mm indicated very swollen. The full range of the sum of the time-weighted swollen throat differences from baseline until 2 hours was -9120 (throat did not feel swollen at all within 1 hour of dosing and lasted 2 hours) to 2880 (maximum swollen throat reported within 1 hour and lasting 2 hours) using the mean baseline SwoTS. Negative values for the differences indicate improvement. Missing values of SwoTS with non-missing values at assessments before and after were calculated using linear interpolation.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=101 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=97 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline
|
-35.5 units on a scale
Standard Deviation 38.92
|
-16.9 units on a scale
Standard Deviation 29.10
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), hourly readings to 24 hours post-dosePopulation: Intent to treat population. Four participants (2 Flurbiprofen, 2 Vehicle) did not have SwoTS recorded after 21 hours and were not included in the analysis.
SwoTS measures how swollen a participant's throat felt using a 100-mm visual analog scale completed by participants. Participants were instructed to swallow and "Place a line on the scale that best characterizes how swollen your throat feels now." A mark at 0-mm indicated not swollen and 100-mm indicated very swollen. The full range of the sum of the time-weighted swollen throat differences from baseline until 24 hours was -100320 (throat did not feel swollen at all within 1 hour of dosing and lasted 24 hours) to 31680 (maximum swollen throat reported within 1 hour and lasting 24 hours) using the mean baseline SwoTS. Negative values for differences indicate improvement.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=99 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=95 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline
|
-542.4 units on a scale
Standard Deviation 487.67
|
-377.4 units on a scale
Standard Deviation 419.95
|
SECONDARY outcome
Timeframe: baseline (pre-dose), post-dose: 1 hour, 2 hoursPopulation: Intent to treat population
STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. SPID2 was calculated as the sum of the time weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9492 (complete pain relief within one hour of dosing that lasts 2 hours) to 2508 (maximum pain within 1 hour lasting 2 hours) using the mean baseline STPIS. If a participant used rescue medication (acetaminophen 650mg was allowed as needed post dose), all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments (recorded or derived due to rescue) were imputed using linear interpolation assuming the time of the missing assessment to be the nominal time since initial dose.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=101 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=97 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2)
|
-37.1 units on a scale
Standard Deviation 37.04
|
-17.9 units on a scale
Standard Deviation 26.54
|
SECONDARY outcome
Timeframe: baseline (pre-dose), 24 hours post dose (measured each hour post dose)Population: Intent to treat population of participants who took the first full dose of medication and had moderate or severe pharyngeal inflammation at baseline.
STPIS measures sore throat pain intensity on a 100-mm visual analog scale completed by participants. A mark at 0-mm indicates no pain upon swallowing and 100-mm indicates severe pain. For the subgroup of patients with moderate/severe pharyngeal inflammation at baseline, SPID24 was calculated as the sum of the time weighted pain intensity differences from baseline until 24 hours. Taking inclusion criteria into account, the full range was -115695 (no pain at any post-dose time (0) - average baseline) to 28505 (maximum possible pain (100) - average baseline). Participants with their last recorded time point \<21 hours were considered Not Evaluable. If a participant used rescue medication, all post-rescue STPIS values in the 24-hour interval were assigned the baseline value for STPIS. Missing scores of STPIS with non-missing STPIS scores at earlier and later assessments were imput
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=57 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=57 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale Over 24 Hours Post-baseline (STPIS SPID24) For Participants With Baseline Practitioner's Assessment of Pharyngeal Inflammation (PAIN) of Moderate or Severe
|
-476.9 units on a scale
Standard Deviation 492.12
|
-351.3 units on a scale
Standard Deviation 425.98
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Intent to treat population
Participants graded the relief of his/her sore throat at 2 hours post initial dose using the Sore Throat Relief Rating Scale (STRRS), which is a 6-category relief scale. The patient was instructed to swallow and asked: "Considering how your throat felt before you took the study medicine, circle the phrase that best describes the relief of your sore throat now." Responses were no relief, slight, mild, moderate, considerable, and complete relief.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=101 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=97 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose
No relief
|
9.9 percentage of participants
|
38.1 percentage of participants
|
|
Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose
Slight relief
|
28.7 percentage of participants
|
22.7 percentage of participants
|
|
Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose
Mild relief
|
27.7 percentage of participants
|
17.5 percentage of participants
|
|
Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose
Moderate relief
|
17.8 percentage of participants
|
18.6 percentage of participants
|
|
Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose
Considerable relief
|
15.8 percentage of participants
|
3.1 percentage of participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Intent to treat population. CLIN was not performed for 3 participants (1 Flurbiprofen, 2 placebo).
Investigators assessed the effectiveness of study medication on the patient's sore throat at 24 hours following initial dose by answering the following question: "Considering the patient's response to the study medicine over the past 24 hours, how do you rate the study medicine as a treatment for sore throat?" Responses were poor, fair, good, very good or excellent.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=100 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=95 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose
Poor
|
25.0 percentage of participants
|
25.3 percentage of participants
|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose
Fair
|
27.0 percentage of participants
|
29.5 percentage of participants
|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose
Good
|
26.0 percentage of participants
|
24.2 percentage of participants
|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose
Very Good
|
14.0 percentage of participants
|
12.6 percentage of participants
|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose
Excellent
|
8.0 percentage of participants
|
8.4 percentage of participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Intent to treat population. One placebo participant did not complete a Patient Satisfaction Score.
After 24 hours of treatment, participants rated their satisfaction with the treatment on a 7-step scale from extremely dissatisfied to extremely satisfied.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=101 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=96 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Participant Satisfaction Score 24 Hours After Initial Dose
Extremely satisfied
|
5.0 percentage of participants
|
5.2 percentage of participants
|
|
Participant Satisfaction Score 24 Hours After Initial Dose
Extremely dissatisfied
|
4.0 percentage of participants
|
5.2 percentage of participants
|
|
Participant Satisfaction Score 24 Hours After Initial Dose
Very dissatisfied
|
4.0 percentage of participants
|
9.4 percentage of participants
|
|
Participant Satisfaction Score 24 Hours After Initial Dose
Dissatisfied
|
10.9 percentage of participants
|
14.6 percentage of participants
|
|
Participant Satisfaction Score 24 Hours After Initial Dose
Somewhat satisfied
|
27.7 percentage of participants
|
32.3 percentage of participants
|
|
Participant Satisfaction Score 24 Hours After Initial Dose
Satisfied
|
23.8 percentage of participants
|
26.0 percentage of participants
|
|
Participant Satisfaction Score 24 Hours After Initial Dose
Very satisified
|
24.8 percentage of participants
|
7.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 7 (end of study)Population: Intent to treat population of participants who completed the study. CLIN was missing for one flurbiprofen participant.
Investigators assessed the effectiveness of study medication on the patient's sore throat at the end of study by answering the following question: "Considering the patient's response to the study medicine over the past 7 days, how do you rate the study medicine as a treatment for sore throat?" Responses were poor, fair, good, very good or excellent.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=96 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=92 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7)
Poor
|
19.8 percentage of participants
|
25.0 percentage of participants
|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7)
Fair
|
22.9 percentage of participants
|
26.1 percentage of participants
|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7)
Good
|
24.0 percentage of participants
|
20.7 percentage of participants
|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7)
Very Good
|
26.0 percentage of participants
|
22.8 percentage of participants
|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7)
Excellent
|
7.3 percentage of participants
|
5.4 percentage of participants
|
SECONDARY outcome
Timeframe: Days 2-7Population: Intent to treat population of participants who were active in the study on day 2. For doses where rescue medication was taken within the 2 hour assessment, all following differences were imputed as zero.
The time weighted summed differences over 2 hours after taking a lozenge after the initial 24-hours post-baseline. STPIS is a validated 100-mm visual analog scale completed by participants that measures "pain on swallowing" (odynophagia). A mark at 0-mm indicates no pain and 100-mm indicates severe pain. SPID2 was calculated as the sum of the time-weighted pain intensity differences from a measurement taken prior to taking a lozenge and at hours 1 + 2 after taking the lozenge during Days 2-7. Data for multiple doses/days were averaged to obtain the values used for calculating SPID2. The full range for SPID2 was -5843 to 6157 with negative values indicating improvement in pain intensity. Assessments were summarized using a repeated measures mixed model, with treatment and center as a fixed effect, time since Baseline as a covariate, and a random effect for participants.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=97 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=92 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Post 24 Hour, Multiple Dose Results: Weighted Sum of Pain Intensity Differences (SPID) Over 2 Hours for the Sore Throat Pain Intensity Scale (STPIS SPID2)
|
-22.7 units on a scale
Standard Error 2.56
|
-16.8 units on a scale
Standard Error 2.61
|
SECONDARY outcome
Timeframe: Days 2-7Population: Intent to treat population of participants who were active in the study on day 2. For doses where rescue medication was taken within the 2 hour assessment, all following differences were imputed as zero.
The time weighted summed differences over 2 hours after taking a lozenge for all lozenges taken after the initial 24-hours post-baseline. To measure the functional effect on pharyngitis, the participant was asked to evaluate his/her difficulty swallowing (dysphagia) using a 100-mm visual analog scale prior to dosing, and 1 hour and 2 hours post dose. The participant was instructed to swallow and "Place a line on the scale that best characterizes how difficult it is to swallow now." A mark at 0-mm indicated not difficult and 100-mm indicated very difficult. Data for multiple doses/days were averaged to obtain the values used for calculating DSS2. The full range for differences was -5626 to 6374 with negative values indicating improvement in pain intensity. Assessments were summarized using a repeated measures mixed model, with treatment and center as a fixed effect, time since Baseline as a covariate, and a random effect for participants.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=97 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=92 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Difficulty Swallowing Scale (DSS2)
|
-21.0 units on a scale
Standard Error 2.49
|
-15.5 units on a scale
Standard Error 2.53
|
SECONDARY outcome
Timeframe: Days 2-7Population: Intent to treat population of participants who were active in the study on day 2
The time weighted summed differences over 2 hours after taking a lozenge for all lozenges taken after the initial 24-hours post-baseline. The participant was asked to evaluate how swollen his/her throat felt using a 100-mm visual analog scale prior to dosing, and 1 hour and 2 hours post dose. The patient was instructed to swallow and "Place a line on the scale that best characterizes how swollen your throat feels now." A mark at 0-mm indicated not swollen and 100-mm indicated very swollen. Data for multiple doses/days were averaged to obtain the values used for calculating SWoTS2. The full range for differences was -5396 to 6604 with negative values indicating improvement in pain intensity. Assessments were summarized using a repeated measures mixed model, with treatment and center as a fixed effect, time since Baseline as a covariate, and a random effect for participants.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=97 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=92 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Swollen Throat Scale (SwoTS2)
|
-19.5 units on a scale
Standard Error 2.49
|
-13.4 units on a scale
Standard Error 2.52
|
SECONDARY outcome
Timeframe: Days 2-7Population: Intent to treat population of participants who were active in the study on day 2
Participants graded the relief of his/her sore throat at 2 hours after taking a lozenge for all lozenges taken after the initial 24-hours post-baseline using the Sore Throat Relief Rating Scale (STRRS), which is a 6-category relief scale. The patient was instructed to swallow and: "Considering how your throat felt before you took the study medicine, circle the phrase that best describes the relief of your sore throat now." Responses following each lozenge were no relief, slight, mild, moderate, considerable, and complete relief. Results summarize responses 2 hours after taking each lozenge.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=636 Lozenges (doses)
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=701 Lozenges (doses)
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing
Slight relief
|
21.7 percentage of doses
|
24.8 percentage of doses
|
|
Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing
Mild relief
|
25.2 percentage of doses
|
19.0 percentage of doses
|
|
Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing
Moderate relief
|
16.5 percentage of doses
|
13.7 percentage of doses
|
|
Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing
Considerable relief
|
18.9 percentage of doses
|
14.7 percentage of doses
|
|
Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing
Complete relief
|
8.0 percentage of doses
|
4.9 percentage of doses
|
|
Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing
No relief
|
9.7 percentage of doses
|
23.0 percentage of doses
|
SECONDARY outcome
Timeframe: Days 1-7Population: Intent to treat population
Participants were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment dosing during the study.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=101 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=97 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Percentage of Participants Who Took Rescue Pain Medication
Yes
|
13.9 percentage of participants
|
25.8 percentage of participants
|
|
Percentage of Participants Who Took Rescue Pain Medication
No
|
86.1 percentage of participants
|
74.2 percentage of participants
|
SECONDARY outcome
Timeframe: Days 1-7Population: Intent to treat population
Participants were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment during the study. Time from initial dose to first rescue medication is summarized by time categories.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=101 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=97 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Time to First Rescue Pain Medication
2 - <4 hours
|
2.0 percentage of participants
|
6.2 percentage of participants
|
|
Time to First Rescue Pain Medication
4 - <6 hours
|
2.0 percentage of participants
|
2.1 percentage of participants
|
|
Time to First Rescue Pain Medication
6 - <24 hours
|
5.9 percentage of participants
|
13.4 percentage of participants
|
|
Time to First Rescue Pain Medication
24 - <72 hours
|
3.0 percentage of participants
|
3.1 percentage of participants
|
|
Time to First Rescue Pain Medication
72 - 168 hours
|
1.0 percentage of participants
|
1.0 percentage of participants
|
|
Time to First Rescue Pain Medication
Did not rescue
|
86.1 percentage of participants
|
74.2 percentage of participants
|
SECONDARY outcome
Timeframe: baseline (pre-dose), 2 hours post-dosePopulation: Safety population
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=101 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=97 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Change From Baseline in Body Temperature at 2 Hours Post Initial Dose
|
-0.2 degrees Fahrenheit
Standard Deviation 0.63
|
-0.0 degrees Fahrenheit
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: baseline (pre-dose), up to Day 7Population: Safety population of participants with a recording at the end of study visit.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=96 Participants
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=91 Participants
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Change From Baseline in Body Temperature at End of Study
|
-0.4 degrees Fahrenheit
Standard Deviation 0.91
|
-0.3 degrees Fahrenheit
Standard Deviation 0.94
|
Adverse Events
Flurbiprofen 8.75 mg Lozenge
Placebo Lozenge
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=101 participants at risk
Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
Placebo Lozenge
n=97 participants at risk
Participants were instructed to suck one study (placebo) lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours for the 7 days of the study. Rescue medication (acetaminophen 650mg) was allowed as needed.
|
|---|---|---|
|
Eye disorders
Lacrimation increased
|
0.00%
0/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Eye disorders
Vision blurred
|
0.00%
0/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
2/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Gastrointestinal disorders
Dyspepsia
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Gastrointestinal disorders
Flatulence
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Gastrointestinal disorders
Gingival erythema
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Gastrointestinal disorders
Haematochezia
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Gastrointestinal disorders
Nausea
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.00%
0/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Gastrointestinal disorders
Oropharyngeal blistering
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Gastrointestinal disorders
Vomiting
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
General disorders
Chills
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
General disorders
Pain
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
General disorders
Pyrexia
|
2.0%
2/101 • Initial dose on Day 1 up to Day 7
|
2.1%
2/97 • Initial dose on Day 1 up to Day 7
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.00%
0/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Infections and infestations
Conjunctivitis viral
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Infections and infestations
Influenza
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Infections and infestations
Oral herpes
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Infections and infestations
Otitis externa
|
0.00%
0/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Infections and infestations
Otitis media
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
3.1%
3/97 • Initial dose on Day 1 up to Day 7
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/101 • Initial dose on Day 1 up to Day 7
|
2.1%
2/97 • Initial dose on Day 1 up to Day 7
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Nervous system disorders
Dizziness
|
2.0%
2/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Nervous system disorders
Headache
|
7.9%
8/101 • Initial dose on Day 1 up to Day 7
|
6.2%
6/97 • Initial dose on Day 1 up to Day 7
|
|
Nervous system disorders
Migraine
|
0.00%
0/101 • Initial dose on Day 1 up to Day 7
|
2.1%
2/97 • Initial dose on Day 1 up to Day 7
|
|
Nervous system disorders
Paraesthesia
|
4.0%
4/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
4/101 • Initial dose on Day 1 up to Day 7
|
2.1%
2/97 • Initial dose on Day 1 up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hypoaesthesia
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.99%
1/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/101 • Initial dose on Day 1 up to Day 7
|
3.1%
3/97 • Initial dose on Day 1 up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
9.9%
10/101 • Initial dose on Day 1 up to Day 7
|
0.00%
0/97 • Initial dose on Day 1 up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/101 • Initial dose on Day 1 up to Day 7
|
1.0%
1/97 • Initial dose on Day 1 up to Day 7
|
Additional Information
Gail Solomon, Director, Clinical Development
Reckitt Benckiser Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60