Trial Outcomes & Findings for A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis (NCT NCT01049334)
NCT ID: NCT01049334
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 -114609 (complete pain relief within 2 minutes of dosing that lasts 24 hours) to 29191 (maximum pain within 2 minutes 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
204 participants
baseline (pre-dose), 24 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-24)
2017-09-21
Participant Flow
Two hundred twenty-seven patients were screened.
Participant milestones
| Measure |
Flurbiprofen 8.75 mg Lozenge
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
102
|
|
Overall Study
COMPLETED
|
93
|
95
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
Flurbiprofen 8.75 mg Lozenge
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis
Baseline characteristics by cohort
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=102 Participants
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=102 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.8 years
STANDARD_DEVIATION 1.48 • n=5 Participants
|
19.8 years
STANDARD_DEVIATION 1.47 • n=7 Participants
|
19.8 years
STANDARD_DEVIATION 1.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
96 participants
n=5 Participants
|
97 participants
n=7 Participants
|
193 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
92 participants
n=5 Participants
|
95 participants
n=7 Participants
|
187 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other, not specified
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Sore Throat Pain Intensity Scale (STPIS)
|
78.8 units on a scale
STANDARD_DEVIATION 8.56 • n=5 Participants
|
80.5 units on a scale
STANDARD_DEVIATION 7.92 • n=7 Participants
|
79.7 units on a scale
STANDARD_DEVIATION 8.27 • n=5 Participants
|
|
Difficulty Swallowing Scale (DSS)
|
76.9 units on a scale
STANDARD_DEVIATION 12.41 • n=5 Participants
|
76.3 units on a scale
STANDARD_DEVIATION 11.04 • n=7 Participants
|
76.6 units on a scale
STANDARD_DEVIATION 11.72 • n=5 Participants
|
|
Swollen Throat Scale (SwoTS)
|
76.6 units on a scale
STANDARD_DEVIATION 13.98 • n=5 Participants
|
79.0 units on a scale
STANDARD_DEVIATION 12.05 • n=7 Participants
|
77.8 units on a scale
STANDARD_DEVIATION 13.07 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline (pre-dose), 24 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-24)Population: Intent to treat population of participants who took the first full dose of medication. Three participants (1 Flurbiprofen, 2 Placebo) did not have sufficient 24 hour data to be included in the primary analysis of the primary endpoint (no entries after 2 hours), but did have sufficient data to be included in other efficacy analyses.
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 -114609 (complete pain relief within 2 minutes of dosing that lasts 24 hours) to 29191 (maximum pain within 2 minutes 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=101 Participants
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=100 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24)
|
-473.7 units on a scale
Standard Error 45.4428
|
-322.3 units on a scale
Standard Error 45.6708
|
SECONDARY outcome
Timeframe: baseline (pre-dose), 2 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2)Population: Intent to treat population of participants who took the first full dose of medication.
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 dosing. The full range was -9405 (complete pain relief within 2 minutes of dosing that lasts 2 hours) to 2395 (maximum pain within 2 minutes 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=102 Participants
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=102 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2)
|
-43.4 units on a scale
Standard Deviation 39.20
|
-23.5 units on a scale
Standard Deviation 29.52
|
SECONDARY outcome
Timeframe: baseline (pre-dose), 2 hours post-dose (every 10 minutes until hour 2)Population: Intent to treat population of participants who took the first full dose of medication.
Participants were asked to evaluate his/her difficulty swallowing (dysphagia) using a 100-mm visual analog scale at Baseline and 2 hours post dose. 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 no difficulty and 100-mm indicated very difficult. Data is reported as the sum of the time-weighted pain intensity differences from baseline until 2 hours post dose. The full range was -9192 (no difficulty swallowing within 10 minutes of dosing that lasts 2 hours) to 2808 (maximum difficulty swallowing within 10 minutes 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=102 Participants
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=102 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline
|
-39.1 units on a scale
Standard Deviation 38.64
|
-16.6 units on a scale
Standard Deviation 29.34
|
SECONDARY outcome
Timeframe: baseline (pre-dose), 24 hours post-dose (every 10 minutes until hour 2, every 30 minutes until hour 6, hourly from 7-24 hours)Population: Intent to treat population of participants who took the first full dose of medication and had DSS recorded after 21-hours.
Participants were asked to evaluate his/her difficulty swallowing (dysphagia) using a 100-mm visual analog scale at Baseline and until 24 hours post dose. 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 no difficulty and 100-mm indicated very difficult. Data is reported as the sum of the time-weighted pain intensity differences from baseline until 24 hours post dose. The full range was -110304 (no difficulty swallowing within 10 minutes of dosing that lasts 24 hours) to 33696 (maximum difficulty swallowing within 10 minutes lasting 24 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 sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=99 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline
|
-460.8 units on a scale
Standard Deviation 498.79
|
-274.3 units on a scale
Standard Deviation 455.35
|
SECONDARY outcome
Timeframe: baseline (pre-dose), 2 hours post-dose (at 1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, and 2 hours)Population: Intent to treat population of participants who took the first full dose of medication.
The participant was asked to evaluate how swollen his/her throat felt using a 100-mm visual analog scale at Baseline and at 1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, and 2 hours. 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. The full range of the sum of the time-weighted swollen throat differences from baseline until 2 hours was -9336 (throat did not feel swollen at all within 1 hour of dosing and lasted 2 hours) to 2664 (maximum swollen throat reported within 1 hour and lasting 2 hours) using the mean baseline SwoTS.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=102 Participants
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=102 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline
|
-39.9 units on a scale
Standard Deviation 39.63
|
-20.1 units on a scale
Standard Deviation 27.28
|
SECONDARY outcome
Timeframe: baseline (pre-dose), 24 hours post-dose (1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, 2 hours, 2½ hours, 3 hours, 3½ hours, 4 hours, 4½ hours, 5 hours, 5½ hours, and 6 hours after the first dose, hourly from 7-24 hours)Population: Intent to treat population of participants who took the first full dose of medication, and had SwoTS recorded after 21 hours. Four participants (1 Flurbiprofen, 3 Vehicle) did not have SwoTS recorded after 21 hours and were not included in the analysis.
The participant was asked to evaluate how swollen his/her throat felt using a 100-mm visual analog scale at Baseline and specified timeframes until 24 hours. 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. The full range of the sum of the time-weighted swollen throat differences from baseline until 24 hours was -112032 (throat did not feel swollen at all within 1 hour of dosing and lasted 24 hours) to 31968 (maximum swollen throat reported within 1 hour and lasting 24 hours) using the mean baseline SwoTS.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=101 Participants
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=99 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline
|
-472.2 units on a scale
Standard Deviation 521.89
|
-355.2 units on a scale
Standard Deviation 432.04
|
SECONDARY outcome
Timeframe: Baseline (pre-dose), 24 hours post-dosePopulation: Intent to treat population of participants whose baseline TPA was \>=8 and had an assessment at hour 24.
Tonsillo-Pharyngitis Assessment, or TPA, is an index of seven clinical features of the pain-producing condition itself, pharyngeal inflammation. The clinical features concern temperature, oropharyngeal color, size of tonsils, number of enanthems, largest size of cervical lymph node, number of lymph nodes, and maximum tenderness of lymph nodes. Each variable was rated on a scale of 0-3, with 0 representing the normal value, and 3 representing severe inflammation. The seven values are added together to create the TPA, ranging from 0-21. Negative change values represent improvement of symptoms.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=79 Participants
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=83 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Change From Baseline at 24 Hours in the Tonsillo-Pharyngitis Assessment (TPA) Scores in Participants With Baseline TPA Scores >=8
|
-1.2 units on a scale
Standard Deviation 2.61
|
-2.0 units on a scale
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: 24 hours post-dosePopulation: Intent to treat population. Three participants withdrew before the 24 hour assessment.
P.A.I.N is a four step scale in which physicians rate the severity of pharyngeal inflammation: No inflammation, mild, moderate and severe inflammation.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=101 Participants
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=100 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Practitioner's Assessment of Pharyngeal Inflammation (P.A.I.N.) Scores at 24 Hours After Initial Dose
No inflammation
|
0 participants
|
1 participants
|
|
Practitioner's Assessment of Pharyngeal Inflammation (P.A.I.N.) Scores at 24 Hours After Initial Dose
Mild inflammation
|
48 participants
|
42 participants
|
|
Practitioner's Assessment of Pharyngeal Inflammation (P.A.I.N.) Scores at 24 Hours After Initial Dose
Moderate inflammation
|
42 participants
|
50 participants
|
|
Practitioner's Assessment of Pharyngeal Inflammation (P.A.I.N.) Scores at 24 Hours After Initial Dose
Severe inflammation
|
11 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Intent to treat population. Three participants withdrew before the 24 hour assessment.
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=101 Participants
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=100 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose
Poor
|
15.8 percentage of participants
|
38.0 percentage of participants
|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose
Fair
|
34.7 percentage of participants
|
28.0 percentage of participants
|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose
Good
|
19.8 percentage of participants
|
18.0 percentage of participants
|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose
Very Good
|
13.9 percentage of participants
|
13.0 percentage of participants
|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose
Excellent
|
15.8 percentage of participants
|
3.0 percentage of participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Intent to treat population. Three participants withdrew before the 24 hour assessment.
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 sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=100 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Participant Satisfaction Scores 24 Hours After Initial Dose
Extremely dissatisfied
|
5.0 percentage of participants
|
10.0 percentage of participants
|
|
Participant Satisfaction Scores 24 Hours After Initial Dose
Very dissatisfied
|
6.9 percentage of participants
|
20.0 percentage of participants
|
|
Participant Satisfaction Scores 24 Hours After Initial Dose
Dissatisfied
|
11.9 percentage of participants
|
14.0 percentage of participants
|
|
Participant Satisfaction Scores 24 Hours After Initial Dose
Somewhat satisfied
|
29.7 percentage of participants
|
28.0 percentage of participants
|
|
Participant Satisfaction Scores 24 Hours After Initial Dose
Satisfied
|
20.8 percentage of participants
|
17.0 percentage of participants
|
|
Participant Satisfaction Scores 24 Hours After Initial Dose
Very satisfied
|
23.8 percentage of participants
|
9.0 percentage of participants
|
|
Participant Satisfaction Scores 24 Hours After Initial Dose
Extremely satisfied
|
2.0 percentage of participants
|
2.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 7Population: Intent to treat population of participants who had an end of study assessment.
Investigators assessed the effectiveness of study medication on the patient's sore throat at the end of the 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=93 Participants
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=95 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at the End of the Study (Day 7)
Poor
|
11.8 percentage of participants
|
31.6 percentage of participants
|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at the End of the Study (Day 7)
Fair
|
28.0 percentage of participants
|
34.7 percentage of participants
|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at the End of the Study (Day 7)
Good
|
30.1 percentage of participants
|
14.7 percentage of participants
|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at the End of the Study (Day 7)
Very Good
|
17.2 percentage of participants
|
14.7 percentage of participants
|
|
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at the End of the Study (Day 7)
Excellent
|
12.9 percentage of participants
|
4.2 percentage of participants
|
SECONDARY outcome
Timeframe: baseline (pre-dose), 24 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-24)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 -116196 (no pain at any post-dose time (0) - average baseline) to 27804 (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 (acetaminophen 650mg was allowed as needed), 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.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=68 Participants
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=67 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
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
|
-451.4 units on a scale
Standard Deviation 491.05
|
-283.4 units on a scale
Standard Deviation 378.06
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Intent to treat population of participants who had a 2 hour assessment.
Participants used a 6-category relief scale (no relief to complete relief) to grade the relief of his/her throat pain. 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."
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=102 Participants
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=102 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Sore Throat Relief Rating Scale (STRRS) At 2 Hours After Initial Dose
No relief
|
18.6 percentage of participants
|
45.1 percentage of participants
|
|
Sore Throat Relief Rating Scale (STRRS) At 2 Hours After Initial Dose
Slight relief
|
23.5 percentage of participants
|
24.5 percentage of participants
|
|
Sore Throat Relief Rating Scale (STRRS) At 2 Hours After Initial Dose
Mild relief
|
23.5 percentage of participants
|
11.8 percentage of participants
|
|
Sore Throat Relief Rating Scale (STRRS) At 2 Hours After Initial Dose
Moderate relief
|
20.6 percentage of participants
|
13.7 percentage of participants
|
|
Sore Throat Relief Rating Scale (STRRS) At 2 Hours After Initial Dose
Considerable relief
|
13.7 percentage of participants
|
4.9 percentage of participants
|
|
Sore Throat Relief Rating Scale (STRRS) At 2 Hours After Initial Dose
Complete relief
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: baseline (pre-dose), up to 23 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-23)Population: Intent to treat population of participants who took the first full dose of medication.
Data reported in summary form in Primary Outcome #1 are reported here at each post-dose timepoint until the comparison resulted in a P-value \<=0.05 between the two treatment arms. STPIS was used to measure sore throat pain intensity using a 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. The full range of the scale varies by timepoint due to the time weighting sum of SPID. The full scale at 40 minutes post dose was -3188 (complete pain relief within 2 minutes of dosing that lasts 40 minutes) to 812 (maximum pain within 2 minutes lasting 40 minutes) using the mean baseline STPIS. If a participant used rescue medication (acetaminophen 650mg was allowed as needed), 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 (rec
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=102 Participants
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=102 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 30
|
-7.2 units on a scale
Standard Deviation 8.41
|
-5.8 units on a scale
Standard Deviation 6.87
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 32
|
-7.9 units on a scale
Standard Deviation 9.09
|
-6.2 units on a scale
Standard Deviation 7.36
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 34
|
-8.6 units on a scale
Standard Deviation 9.77
|
-6.6 units on a scale
Standard Deviation 7.87
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 36
|
-9.3 units on a scale
Standard Deviation 10.45
|
-7.1 units on a scale
Standard Deviation 8.37
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 38
|
-10.1 units on a scale
Standard Deviation 11.14
|
-7.5 units on a scale
Standard Deviation 8.87
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 40
|
-10.8 units on a scale
Standard Deviation 11.80
|
-7.9 units on a scale
Standard Deviation 9.38
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 2
|
-0.1 units on a scale
Standard Deviation 0.26
|
-0.2 units on a scale
Standard Deviation 0.33
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 4
|
-0.3 units on a scale
Standard Deviation 0.62
|
-0.4 units on a scale
Standard Deviation 0.69
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 6
|
-0.6 units on a scale
Standard Deviation 1.05
|
-0.8 units on a scale
Standard Deviation 1.14
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 8
|
-0.9 units on a scale
Standard Deviation 1.56
|
-1.2 units on a scale
Standard Deviation 1.60
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 10
|
-1.4 units on a scale
Standard Deviation 2.10
|
-1.6 units on a scale
Standard Deviation 2.11
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 12
|
-1.9 units on a scale
Standard Deviation 2.68
|
-2.1 units on a scale
Standard Deviation 2.59
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 14
|
-2.4 units on a scale
Standard Deviation 3.30
|
-2.5 units on a scale
Standard Deviation 3.08
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 16
|
-3.0 units on a scale
Standard Deviation 3.94
|
-2.9 units on a scale
Standard Deviation 3.56
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 18
|
-3.5 units on a scale
Standard Deviation 4.56
|
-3.3 units on a scale
Standard Deviation 4.01
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 20
|
-4.1 units on a scale
Standard Deviation 5.19
|
-3.7 units on a scale
Standard Deviation 4.47
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 22
|
-4.7 units on a scale
Standard Deviation 5.83
|
-4.1 units on a scale
Standard Deviation 4.95
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 24
|
-5.2 units on a scale
Standard Deviation 6.46
|
-4.5 units on a scale
Standard Deviation 5.43
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 26
|
-5.9 units on a scale
Standard Deviation 7.12
|
-4.9 units on a scale
Standard Deviation 5.69
|
|
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) at Each Post-Dose Time Point Until the Time Point at Which Comparison of the Arms Yielded a P-value <=0.05
Minutes post dose: 28
|
-6.5 units on a scale
Standard Deviation 7.76
|
-5.3 units on a scale
Standard Deviation 6.37
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Intent to treat population of participants who completed the Definite Improvement Level (DIL) following study completion.
As part of a protocol amendment, some participants defined a definite improvement level (DIL) relative to their actual pretreatment STPIS on the 100-mm visual analog scale. This was done after completing the 7 day trial. An alternative definition of STPIS time to onset of relief was the time from initial dose to the time the participant reaching DIL for at least 30 minutes. Data were censored if DIL was not achieved by 120 minutes following initial dose. Definite improvement must also occur prior to re-dosing or using rescue medication.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=58 Participants
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=61 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Kaplan-Meier Estimates for Sore Throat Pain Intensity Scale (STPIS) Time to Definite Improvement
|
NA minutes
Too few participants reached DIL within 2 hours
|
NA minutes
Too few participants reached DIL within 2 hours
|
SECONDARY outcome
Timeframe: 6 hoursPopulation: Intent to treat population of participants who completed the Definite Improvement Level (DIL) following study completion.
As part of a protocol amendment, some participants defined a definite improvement level (DIL) relative to their actual pretreatment STPIS on the 100-mm visual analog scale. This was done after completing the 7 day trial. The time of first achieving DIL for 30 minutes within 6 hours (or until rescue or re-dosing) post-dosing will be determined. And the time falling below DIL within 6 hours will be determined. Duration is then defined as the time from first DIL until falling below DIL. Duration was set to zero if the STPIS score does not reach the DIL for at least 30 minutes for STPIS during the 6 hours.
Outcome measures
| Measure |
Flurbiprofen 8.75 mg Lozenge
n=58 Participants
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=61 Participants
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Kaplan-Meier Estimates for Sore Throat Pain Intensity Scale (STPIS) Time to Definite Improvement Duration of Relief Using Participant-Defined Definite Improvement Levels (DIL)
|
75.2 minutes
Standard Deviation 102.41
|
29.4 minutes
Standard Deviation 65.06
|
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=102 participants at risk
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
Placebo Lozenge
n=102 participants at risk
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.98%
1/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Ear and labyrinth disorders
Tinnitis
|
0.98%
1/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Ear and labyrinth disorders
Conjunctivitis
|
0.98%
1/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Ear and labyrinth disorders
Ocular hyperaemia
|
0.98%
1/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Ear and labyrinth disorders
Abnormal sensation in eye
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
3/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
2.9%
3/102 • Initial dose up to Day 7
|
2.0%
2/102 • Initial dose up to Day 7
|
|
Gastrointestinal disorders
Oral pain
|
2.9%
3/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Gastrointestinal disorders
Nausea
|
2.0%
2/102 • Initial dose up to Day 7
|
4.9%
5/102 • Initial dose up to Day 7
|
|
Gastrointestinal disorders
Stomatitis
|
2.0%
2/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Gastrointestinal disorders
Chelilitis
|
0.98%
1/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Gastrointestinal disorders
Gingivitis
|
0.98%
1/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Gastrointestinal disorders
Oral discomfort
|
0.98%
1/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
General disorders
Fatigue
|
0.98%
1/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
General disorders
Chills
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
General disorders
Pain
|
0.00%
0/102 • Initial dose up to Day 7
|
2.9%
3/102 • Initial dose up to Day 7
|
|
General disorders
Pyrexia
|
0.00%
0/102 • Initial dose up to Day 7
|
2.0%
2/102 • Initial dose up to Day 7
|
|
Infections and infestations
Tonsillitis
|
3.9%
4/102 • Initial dose up to Day 7
|
2.9%
3/102 • Initial dose up to Day 7
|
|
Infections and infestations
Otitis media
|
2.9%
3/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Infections and infestations
Bronchitis
|
0.98%
1/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Infections and infestations
Sinusitis
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Injury, poisoning and procedural complications
Bite
|
0.98%
1/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.98%
1/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.98%
1/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Nervous system disorders
Paraesthesia
|
3.9%
4/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Nervous system disorders
Headache
|
2.9%
3/102 • Initial dose up to Day 7
|
5.9%
6/102 • Initial dose up to Day 7
|
|
Nervous system disorders
Paraesthesia oral
|
2.0%
2/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Nervous system disorders
Somnolence
|
0.98%
1/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Nervous system disorders
Migraine
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
2.9%
3/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
2/102 • Initial dose up to Day 7
|
2.0%
2/102 • Initial dose up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
2/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.98%
1/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.98%
1/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal swelling
|
0.98%
1/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.98%
1/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/102 • Initial dose up to Day 7
|
0.98%
1/102 • Initial dose up to Day 7
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.98%
1/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose up to Day 7
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.98%
1/102 • Initial dose up to Day 7
|
0.00%
0/102 • Initial dose 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