Pharyngitis
Conditions
Keywords
pharyngitis, swollen throat, difficulty swallowing
Brief summary
The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen lozenge throughout the course of treating sore throat due to acute pharyngitis.
Detailed description
Per randomization to the treatments and under double-blind conditions, patients were instructed to suck 1 sugar-based, flavoured flurbiprofen 8.75 mg lozenge or 1 sugar-based, flavoured matching vehicle control/placebo lozenge and remained at the study center for a 2-hour observation period to assess their responses to the study medication during the initial 2-hour post-dose period. Patients were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment dosing during the study. After the initial 2 hours in the research center, patients were discharged with an outpatient diary to continue (while awake) to document hourly assessments of Sore Throat Pain Intensity Scale (STPIS), Difficulty Swallowing Scale (DSS), and Swollen Throat Scale (SwoTS) through 24 hours. They used the assigned lozenges as needed every 3-6 hours, up to 5 lozenges over 24 hours. A Follow-Up Visit was conducted for the 24-hour assessments. Patients received additional study lozenges for use as needed (up to 5 lozenges per 24 hours) over the following 6 days, rescue medication (acetaminophen 650 mg) and a Diary to document their safety and efficacy assessments immediately before and postdose after each as-needed use of a lozenge for the remaining days in the 7-day treatment period. At the end of the 7-day trial, patients returned to the research center for final assessments, review of adverse events over the week, and discharge from the study.
Interventions
DRUGplacebo
Sugar-based lozenge flavoured to match the active treatment lozenge. Instructions were to suck one lozenge until gone, every 3-6 hours as needed for sore throat pain. The participant took nothing by mouth except study medication during the first two hours while at the site. For each re-dosing during the remaining time in the study, alcohol and caffeine-containing beverages (e.g., coffee, tea, hot chocolate, caffeinated soft drinks) were not consumed within 1 hour before the participant used a study medication lozenge.
DRUGflurbiprofen
Sugar-based, flavoured flurbiprofen 8.75 mg lozenge. Instructions were to suck one lozenge until gone, every 3-6 hours as needed for pain. The participant took nothing by mouth except study medication during the first two hours while at the site. For each re-dosing during the remaining time in the study, alcohol and caffeine-containing beverages (e.g., coffee, tea, hot chocolate, caffeinated soft drinks) were not consumed within 1 hour before the participant used a study medication lozenge.
DRUGacetaminophen 650mg
Rescue medication to be taken as needed. Rescue medication was not blinded.
Sponsors
Reckitt Benckiser LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient has a complaint of sore throat. 2. If the patient is a female of childbearing potential, she has been using effective contraception since the last date of menses and is not breast-feeding or lactating. 3. If the patient is a female of childbearing potential, the patient must have a negative urine pregnancy. 4. The patient has provided written informed consent prior to any study-related procedures.
Exclusion criteria
1. The patient has a history of an upper gastrointestinal ulcer within the past 60 days, is currently experiencing clinically significant upper gastrointestinal complaints, or is currently taking medication regularly (≥ three times in the previous week). 2. The patient has a history of any hepatic disease or renal dysfunction. 3. The patient has a history of chronic analgesic use (≥ three times per week over the prior four weeks). (Patients on low-dose aspirin therapy may be allowed in the study per investigator's clinical decision.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24) | baseline (pre-dose), post-dose - hourly up to 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline | Baseline (pre-dose), hourly readings to 24 hours post-dose | 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. |
| Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline | Baseline (pre-dose), hourly readings to 2 hours post-dose | 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. |
| Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline | Baseline (pre-dose), hourly readings to 24 hours post-dose | 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. |
| Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2) | baseline (pre-dose), post-dose: 1 hour, 2 hours | 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. |
| 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 | baseline (pre-dose), 24 hours post dose (measured each hour post dose) | 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 |
| Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose | 2 hours | 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. |
| Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose | 24 hours | 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. |
| Participant Satisfaction Score 24 Hours After Initial Dose | 24 hours | After 24 hours of treatment, participants rated their satisfaction with the treatment on a 7-step scale from extremely dissatisfied to extremely satisfied. |
| Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline | Baseline (pre-dose), Hours 1 and 2 post-dose | 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. |
| 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) | Days 2-7 | 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. |
| Change From Baseline in Body Temperature at 2 Hours Post Initial Dose | baseline (pre-dose), 2 hours post-dose | — |
| Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Difficulty Swallowing Scale (DSS2) | Days 2-7 | 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. |
| Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Swollen Throat Scale (SwoTS2) | Days 2-7 | 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. |
| Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing | Days 2-7 | 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. |
| Percentage of Participants Who Took Rescue Pain Medication | Days 1-7 | Participants were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment dosing during the study. |
| Time to First Rescue Pain Medication | Days 1-7 | 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. |
| Change From Baseline in Body Temperature at End of Study | baseline (pre-dose), up to Day 7 | — |
| Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7) | Day 7 (end of study) | 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. |
Countries
United States
Participant flow
Pre-assignment details
Three hundred and thirty-six patients were screened.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 101 |
| 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. | 97 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Other | 1 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Flurbiprofen 8.75 mg Lozenge | Placebo Lozenge | Total |
|---|---|---|---|
| Age, Continuous | 33.5 years STANDARD_DEVIATION 11.03 | 34.2 years STANDARD_DEVIATION 11.17 | 33.9 years STANDARD_DEVIATION 11 |
| Difficulty Swallowing Scale (DSS) | 77.9 units on a scale STANDARD_DEVIATION 10.55 | 78.2 units on a scale STANDARD_DEVIATION 10.3 | 78.0 units on a scale STANDARD_DEVIATION 10.45 |
| Race/Ethnicity, Customized Asian | 10 participants | 10 participants | 20 participants |
| Race/Ethnicity, Customized Black or African | 13 participants | 14 participants | 27 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 16 participants | 10 participants | 26 participants |
| Race/Ethnicity, Customized Multi-racial (no primary) | 3 participants | 3 participants | 6 participants |
| Race/Ethnicity, Customized Non-Hispanic or non-Latino | 85 participants | 87 participants | 172 participants |
| Race/Ethnicity, Customized Other, not specified | 8 participants | 3 participants | 11 participants |
| Race/Ethnicity, Customized White | 67 participants | 67 participants | 134 participants |
| Sex: Female, Male Female | 61 Participants | 58 Participants | 119 Participants |
| Sex: Female, Male Male | 40 Participants | 39 Participants | 79 Participants |
| Sore Throat Pain Intensity Scale (STPIS) | 79.1 units on a scale STANDARD_DEVIATION 8.09 | 79.1 units on a scale STANDARD_DEVIATION 8.37 | 79.1 units on a scale STANDARD_DEVIATION 8.21 |
| Swollen Throat Scale (SwoTS) | 76.0 units on a scale STANDARD_DEVIATION 12.9 | 76.0 units on a scale STANDARD_DEVIATION 12.7 | 76.0 units on a scale STANDARD_DEVIATION 12.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 101 | 28 / 97 |
| serious Total, serious adverse events | 0 / 101 | 0 / 97 |
Outcome results
Primary
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24)
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.
Time frame: baseline (pre-dose), post-dose - hourly up to 24 hours
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Placebo Lozenge | Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24) | -326.5 units on a scale | Standard Deviation 386.83 |
p-value: 0.002195% CI: [-321, -72.2]ANOVA
Secondary
Change From Baseline in Body Temperature at 2 Hours Post Initial Dose
Time frame: baseline (pre-dose), 2 hours post-dose
Population: Safety population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | Change From Baseline in Body Temperature at 2 Hours Post Initial Dose | -0.2 degrees Fahrenheit | Standard Deviation 0.63 |
| Placebo Lozenge | Change From Baseline in Body Temperature at 2 Hours Post Initial Dose | -0.0 degrees Fahrenheit | Standard Deviation 0.82 |
p-value: 0.028895% CI: [-0.4, 0]ANOVA
Secondary
Change From Baseline in Body Temperature at End of Study
Time frame: baseline (pre-dose), up to Day 7
Population: Safety population of participants with a recording at the end of study visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | Change From Baseline in Body Temperature at End of Study | -0.4 degrees Fahrenheit | Standard Deviation 0.91 |
| Placebo Lozenge | Change From Baseline in Body Temperature at End of Study | -0.3 degrees Fahrenheit | Standard Deviation 0.94 |
p-value: 0.427495% CI: [-0.3, 0.1]ANOVA
Secondary
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose
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.
Time frame: 24 hours
Population: Intent to treat population. CLIN was not performed for 3 participants (1 Flurbiprofen, 2 placebo).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Placebo Lozenge | Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose | Excellent | 8.4 percentage of participants |
| Placebo Lozenge | Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose | Poor | 25.3 percentage of participants |
| Placebo Lozenge | Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose | Fair | 29.5 percentage of participants |
| Placebo Lozenge | Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose | Good | 24.2 percentage of participants |
| Placebo Lozenge | Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose | Very Good | 12.6 percentage of participants |
p-value: 0.8827Wilcoxon (Mann-Whitney)
Secondary
Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7)
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.
Time frame: Day 7 (end of study)
Population: Intent to treat population of participants who completed the study. CLIN was missing for one flurbiprofen participant.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Placebo Lozenge | Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7) | Excellent | 5.4 percentage of participants |
| Placebo Lozenge | Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7) | Poor | 25.0 percentage of participants |
| Placebo Lozenge | Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7) | Fair | 26.1 percentage of participants |
| Placebo Lozenge | Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7) | Good | 20.7 percentage of participants |
| Placebo Lozenge | Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at End of Study (Day 7) | Very Good | 22.8 percentage of participants |
Secondary
Participant Satisfaction Score 24 Hours After Initial Dose
After 24 hours of treatment, participants rated their satisfaction with the treatment on a 7-step scale from extremely dissatisfied to extremely satisfied.
Time frame: 24 hours
Population: Intent to treat population. One placebo participant did not complete a Patient Satisfaction Score.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | Participant Satisfaction Score 24 Hours After Initial Dose | Very dissatisfied | 4.0 percentage of participants |
| Flurbiprofen 8.75 mg Lozenge | Participant Satisfaction Score 24 Hours After Initial Dose | Satisfied | 23.8 percentage of participants |
| Flurbiprofen 8.75 mg Lozenge | Participant Satisfaction Score 24 Hours After Initial Dose | Extremely dissatisfied | 4.0 percentage of participants |
| Flurbiprofen 8.75 mg Lozenge | Participant Satisfaction Score 24 Hours After Initial Dose | Very satisified | 24.8 percentage of participants |
| Flurbiprofen 8.75 mg Lozenge | Participant Satisfaction Score 24 Hours After Initial Dose | Somewhat satisfied | 27.7 percentage of participants |
| Flurbiprofen 8.75 mg Lozenge | Participant Satisfaction Score 24 Hours After Initial Dose | Extremely satisfied | 5.0 percentage of participants |
| Flurbiprofen 8.75 mg Lozenge | Participant Satisfaction Score 24 Hours After Initial Dose | Dissatisfied | 10.9 percentage of participants |
| Placebo Lozenge | Participant Satisfaction Score 24 Hours After Initial Dose | Extremely satisfied | 5.2 percentage of participants |
| Placebo Lozenge | Participant Satisfaction Score 24 Hours After Initial Dose | Dissatisfied | 14.6 percentage of participants |
| Placebo Lozenge | Participant Satisfaction Score 24 Hours After Initial Dose | Extremely dissatisfied | 5.2 percentage of participants |
| Placebo Lozenge | Participant Satisfaction Score 24 Hours After Initial Dose | Very dissatisfied | 9.4 percentage of participants |
| Placebo Lozenge | Participant Satisfaction Score 24 Hours After Initial Dose | Somewhat satisfied | 32.3 percentage of participants |
| Placebo Lozenge | Participant Satisfaction Score 24 Hours After Initial Dose | Satisfied | 26.0 percentage of participants |
| Placebo Lozenge | Participant Satisfaction Score 24 Hours After Initial Dose | Very satisified | 7.3 percentage of participants |
p-value: 0.0105Wilcoxon (Mann-Whitney)
Secondary
Percentage of Participants Who Took Rescue Pain Medication
Participants were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment dosing during the study.
Time frame: Days 1-7
Population: Intent to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | Percentage of Participants Who Took Rescue Pain Medication | Yes | 13.9 percentage of participants |
| Flurbiprofen 8.75 mg Lozenge | Percentage of Participants Who Took Rescue Pain Medication | No | 86.1 percentage of participants |
| Placebo Lozenge | Percentage of Participants Who Took Rescue Pain Medication | Yes | 25.8 percentage of participants |
| Placebo Lozenge | Percentage of Participants Who Took Rescue Pain Medication | No | 74.2 percentage of participants |
p-value: 0.0322Regression, Logistic
Secondary
Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing
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.
Time frame: Days 2-7
Population: Intent to treat population of participants who were active in the study on day 2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing | No relief | 9.7 percentage of doses |
| Flurbiprofen 8.75 mg Lozenge | Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing | Slight relief | 21.7 percentage of doses |
| Flurbiprofen 8.75 mg Lozenge | Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing | Mild relief | 25.2 percentage of doses |
| Flurbiprofen 8.75 mg Lozenge | Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing | Moderate relief | 16.5 percentage of doses |
| Flurbiprofen 8.75 mg Lozenge | Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing | Considerable relief | 18.9 percentage of doses |
| Flurbiprofen 8.75 mg Lozenge | Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing | Complete relief | 8.0 percentage of doses |
| Placebo Lozenge | Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing | Considerable relief | 14.7 percentage of doses |
| Placebo Lozenge | Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing | No relief | 23.0 percentage of doses |
| Placebo Lozenge | Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing | Moderate relief | 13.7 percentage of doses |
| Placebo Lozenge | Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing | Slight relief | 24.8 percentage of doses |
| Placebo Lozenge | Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing | Complete relief | 4.9 percentage of doses |
| Placebo Lozenge | Post 24 Hour, Multiple Dose Results: Sore Throat Relief As Reported by Participants 2 Hours After Dosing | Mild relief | 19.0 percentage of doses |
p-value: 0.019595% CI: [0.1, 0.9]ANOVA
Secondary
Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Difficulty Swallowing Scale (DSS2)
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.
Time frame: Days 2-7
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Placebo Lozenge | Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Difficulty Swallowing Scale (DSS2) | -15.5 units on a scale | Standard Error 2.53 |
p-value: 0.087195% CI: [-11.7, 0.8]ANOVA
Secondary
Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Swollen Throat Scale (SwoTS2)
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.
Time frame: Days 2-7
Population: Intent to treat population of participants who were active in the study on day 2
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Placebo Lozenge | Post 24 Hour, Multiple Dose Results: Weighted Sum of Differences Over 2 Hours for Swollen Throat Scale (SwoTS2) | -13.4 units on a scale | Standard Error 2.52 |
p-value: 0.059595% CI: [-12.3, 0.2]ANOVA
Secondary
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)
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.
Time frame: Days 2-7
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Placebo Lozenge | 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) | -16.8 units on a scale | Standard Error 2.61 |
p-value: 0.074395% CI: [-12.4, 0.6]ANOVA
Secondary
Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose
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.
Time frame: 2 hours
Population: Intent to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose | Slight relief | 28.7 percentage of participants |
| Flurbiprofen 8.75 mg Lozenge | Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose | Moderate relief | 17.8 percentage of participants |
| Flurbiprofen 8.75 mg Lozenge | Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose | Mild relief | 27.7 percentage of participants |
| Flurbiprofen 8.75 mg Lozenge | Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose | Considerable relief | 15.8 percentage of participants |
| Flurbiprofen 8.75 mg Lozenge | Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose | No relief | 9.9 percentage of participants |
| Placebo Lozenge | Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose | Considerable relief | 3.1 percentage of participants |
| Placebo Lozenge | Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose | No relief | 38.1 percentage of participants |
| Placebo Lozenge | Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose | Slight relief | 22.7 percentage of participants |
| Placebo Lozenge | Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose | Mild relief | 17.5 percentage of participants |
| Placebo Lozenge | Sore Throat Relief As Reported by Participants 2 Hours After Initial Dose | Moderate relief | 18.6 percentage of participants |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Time to First Rescue Pain Medication
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.
Time frame: Days 1-7
Population: Intent to treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | Time to First Rescue Pain Medication | 2 - <4 hours | 2.0 percentage of participants |
| Flurbiprofen 8.75 mg Lozenge | Time to First Rescue Pain Medication | 4 - <6 hours | 2.0 percentage of participants |
| Flurbiprofen 8.75 mg Lozenge | Time to First Rescue Pain Medication | 6 - <24 hours | 5.9 percentage of participants |
| Flurbiprofen 8.75 mg Lozenge | Time to First Rescue Pain Medication | 24 - <72 hours | 3.0 percentage of participants |
| Flurbiprofen 8.75 mg Lozenge | Time to First Rescue Pain Medication | 72 - 168 hours | 1.0 percentage of participants |
| Flurbiprofen 8.75 mg Lozenge | Time to First Rescue Pain Medication | Did not rescue | 86.1 percentage of participants |
| Placebo Lozenge | Time to First Rescue Pain Medication | 72 - 168 hours | 1.0 percentage of participants |
| Placebo Lozenge | Time to First Rescue Pain Medication | 2 - <4 hours | 6.2 percentage of participants |
| Placebo Lozenge | Time to First Rescue Pain Medication | 24 - <72 hours | 3.1 percentage of participants |
| Placebo Lozenge | Time to First Rescue Pain Medication | 4 - <6 hours | 2.1 percentage of participants |
| Placebo Lozenge | Time to First Rescue Pain Medication | Did not rescue | 74.2 percentage of participants |
| Placebo Lozenge | Time to First Rescue Pain Medication | 6 - <24 hours | 13.4 percentage of participants |
p-value: 0.0276Log Rank
Secondary
Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline
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.
Time frame: Baseline (pre-dose), hourly readings to 24 hours post-dose
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Placebo Lozenge | Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline | -379.4 units on a scale | Standard Deviation 397.66 |
p-value: 0.005495% CI: [-305.7, -53.8]ANOVA
Secondary
Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline
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.
Time frame: Baseline (pre-dose), Hours 1 and 2 post-dose
Population: Intent to treat population of participants who took the first full dose of medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline | -37.1 units on a scale | Standard Deviation 39.6 |
| Placebo Lozenge | Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline | -18.1 units on a scale | Standard Deviation 29.43 |
p-value: 0.000295% CI: [-28.7, -9.3]ANOVA
Secondary
Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline
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.
Time frame: Baseline (pre-dose), hourly readings to 24 hours post-dose
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Placebo Lozenge | Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline | -377.4 units on a scale | Standard Deviation 419.95 |
p-value: 0.008795% CI: [-293.7, -43.1]ANOVA
Secondary
Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline
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.
Time frame: Baseline (pre-dose), hourly readings to 2 hours post-dose
Population: Intent to treat population of participants who took the first full dose of medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Placebo Lozenge | Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline | -16.9 units on a scale | Standard Deviation 29.1 |
p-value: 0.000895% CI: [-25.9, -7]ANOVA
Secondary
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
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Placebo Lozenge | 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 | -351.3 units on a scale | Standard Deviation 425.98 |
p-value: 0.184495% CI: [-295.3, 57.5]ANOVA
Secondary
Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2)
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.
Time frame: baseline (pre-dose), post-dose: 1 hour, 2 hours
Population: Intent to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Flurbiprofen 8.75 mg Lozenge | 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 |
| Placebo Lozenge | Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2) | -17.9 units on a scale | Standard Deviation 26.54 |
p-value: <0.000195% CI: [-28, -10]ANOVA