Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01049334
Recruitment Status : Completed
First Posted : January 14, 2010
Results First Posted : September 21, 2017
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pharyngitis
Interventions Drug: Placebo
Drug: Flurbiprofen
Enrollment 204
Recruitment Details  
Pre-assignment Details Two hundred twenty-seven patients were screened.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days. Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Period Title: Overall Study
Started 102 102
Completed 93 95
Not Completed 9 7
Reason Not Completed
Withdrawal by Subject             5             3
Adverse Event             2             3
Physician Decision             2             0
Protocol Violation             0             1
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge Total
Hide Arm/Group Description Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days. Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days. Total of all reporting groups
Overall Number of Baseline Participants 102 102 204
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 102 participants 204 participants
19.8  (1.48) 19.8  (1.47) 19.8  (1.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 102 participants 204 participants
Female
54
  52.9%
63
  61.8%
117
  57.4%
Male
48
  47.1%
39
  38.2%
87
  42.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants 102 participants 204 participants
Hispanic or Latino 6 5 11
Not Hispanic or Latino 96 97 193
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants 102 participants 204 participants
Asian 3 1 4
Native Hawaiian or Other Pacific Islander 0 1 1
Black or African 5 2 7
White 92 95 187
Multi-racial 0 1 1
Other, not specified 2 2 4
Sore Throat Pain Intensity Scale (STPIS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 102 participants 102 participants 204 participants
78.8  (8.56) 80.5  (7.92) 79.7  (8.27)
[1]
Measure Description: 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.
Difficulty Swallowing Scale (DSS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 102 participants 102 participants 204 participants
76.9  (12.41) 76.3  (11.04) 76.6  (11.72)
[1]
Measure Description: Participants were asked to evaluate his/her difficulty swallowing (dysphagia) using a 100-mm visual analog scale. 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.
Swollen Throat Scale (SwoTS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 102 participants 102 participants 204 participants
76.6  (13.98) 79.0  (12.05) 77.8  (13.07)
[1]
Measure Description: he participant was asked to evaluate how swollen his/her throat felt using a 100-mm visual analog scale. 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.
1.Primary Outcome
Title Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 24 Hours Post-baseline (STPIS SPID24)
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description:
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Overall Number of Participants Analyzed 101 100
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-473.7  (45.4428) -322.3  (45.6708)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0201
Comments The a priori threshold for statistical significance is 0.05. No adjustments for statistical multiplicity were required.
Method ANOVA
Comments Treatment as a fixed effect and baseline STPIS as a covariate.
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -151.5
Confidence Interval (2-Sided) 95%
-278.9 to -24.0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Pain Intensity Scale (STPIS) Over the 2 Hours Post-baseline (STPIS SPID2)
Hide Description

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.

Time Frame baseline (pre-dose), 2 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population of participants who took the first full dose of medication.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description:
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Overall Number of Participants Analyzed 102 102
Mean (Standard Deviation)
Unit of Measure: units on a scale
-43.4  (39.20) -23.5  (29.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.
Method ANOVA
Comments Treatment as a fixed effect and baseline of the variable predicted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -19.6
Confidence Interval (2-Sided) 95%
-29.2 to -9.9
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 2 Hours From Baseline
Hide Description

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.

Time Frame baseline (pre-dose), 2 hours post-dose (every 10 minutes until hour 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population of participants who took the first full dose of medication.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description:
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Overall Number of Participants Analyzed 102 102
Mean (Standard Deviation)
Unit of Measure: units on a scale
-39.1  (38.64) -16.6  (29.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.
Method ANOVA
Comments Treatment as a fixed effect and baseline of the variable predicted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -22.3
Confidence Interval (2-Sided) 95%
-31.7 to -12.9
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time Weighted Summed Differences in Difficulty Swallowing Scale (DSS) During the Initial 24 Hours From Baseline
Hide Description

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.

Time Frame baseline (pre-dose), 24 hours post-dose (every 10 minutes until hour 2, every 30 minutes until hour 6, hourly from 7-24 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population of participants who took the first full dose of medication and had DSS recorded after 21-hours.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description:
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Overall Number of Participants Analyzed 101 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
-460.8  (498.79) -274.3  (455.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0071
Comments The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.
Method ANOVA
Comments Treatment as a fixed effect and baseline of the variable predicted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -181.7
Confidence Interval (2-Sided) 95%
-313.7 to -50.0
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 2 Hours From Baseline
Hide Description

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.

Time Frame baseline (pre-dose), 2 hours post-dose (at 1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, and 2 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population of participants who took the first full dose of medication.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description:
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Overall Number of Participants Analyzed 102 102
Mean (Standard Deviation)
Unit of Measure: units on a scale
-39.9  (39.63) -20.1  (27.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.
Method ANOVA
Comments Treatment as a fixed effect and baseline of the variable predicted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -20.8
Confidence Interval (2-Sided) 95%
-30.2 to -11.2
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time Weighted Summed Differences in Swollen Throat Scale (SwoTS) During the Initial 24 Hours From Baseline
Hide Description

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.

Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description:
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Overall Number of Participants Analyzed 101 99
Mean (Standard Deviation)
Unit of Measure: units on a scale
-472.2  (521.89) -355.2  (432.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0393
Comments The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.
Method ANOVA
Comments Treatment as a fixed effect and baseline of the variable predicted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -137.6
Confidence Interval (2-Sided) 95%
-268.5 to -6.8
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline at 24 Hours in the Tonsillo-Pharyngitis Assessment (TPA) Scores in Participants With Baseline TPA Scores >=8
Hide Description

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.

Time Frame Baseline (pre-dose), 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population of participants whose baseline TPA was >=8 and had an assessment at hour 24.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description:
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Overall Number of Participants Analyzed 79 83
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.2  (2.61) -2.0  (2.71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0459
Comments The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Practitioner's Assessment of Pharyngeal Inflammation (P.A.I.N.) Scores at 24 Hours After Initial Dose
Hide Description 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.
Time Frame 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Three participants withdrew before the 24 hour assessment.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description:
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Overall Number of Participants Analyzed 101 100
Measure Type: Number
Unit of Measure: participants
No inflammation 0 1
Mild inflammation 48 42
Moderate inflammation 42 50
Severe inflammation 11 7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8383
Comments The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at 24 Hours After Initial Dose
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Three participants withdrew before the 24 hour assessment.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description:
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Overall Number of Participants Analyzed 101 100
Measure Type: Number
Unit of Measure: percentage of participants
Poor 15.8 38.0
Fair 34.7 28.0
Good 19.8 18.0
Very Good 13.9 13.0
Excellent 15.8 3.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Participant Satisfaction Scores 24 Hours After Initial Dose
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population. Three participants withdrew before the 24 hour assessment.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description:
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Overall Number of Participants Analyzed 101 100
Measure Type: Number
Unit of Measure: percentage of participants
Extremely dissatisfied 5.0 10.0
Very dissatisfied 6.9 20.0
Dissatisfied 11.9 14.0
Somewhat satisfied 29.7 28.0
Satisfied 20.8 17.0
Very satisfied 23.8 9.0
Extremely satisfied 2.0 2.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Investigators' Clinical Assessment (CLIN) Of Study Medication as a Treatment for Sore Throat at the End of the Study (Day 7)
Hide Description 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.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population of participants who had an end of study assessment.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description:
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Overall Number of Participants Analyzed 93 95
Measure Type: Number
Unit of Measure: percentage of participants
Poor 11.8 31.6
Fair 28.0 34.7
Good 30.1 14.7
Very Good 17.2 14.7
Excellent 12.9 4.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Secondary Outcome
Title 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
Hide Description

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.

Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population of participants who took the first full dose of medication and had moderate or severe pharyngeal inflammation at baseline.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description:
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Overall Number of Participants Analyzed 68 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
-451.4  (491.05) -283.4  (378.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0435
Comments The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -156.3
Confidence Interval (2-Sided) 95%
-307.9 to -4.6
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Sore Throat Relief Rating Scale (STRRS) At 2 Hours After Initial Dose
Hide Description

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."

Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population of participants who had a 2 hour assessment.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description:
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Overall Number of Participants Analyzed 102 102
Measure Type: Number
Unit of Measure: percentage of participants
No relief 18.6 45.1
Slight relief 23.5 24.5
Mild relief 23.5 11.8
Moderate relief 20.6 13.7
Considerable relief 13.7 4.9
Complete relief 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments The a priori threshold for statistical significance is 0.05. Closed-sequential approach to control type I error: analyses through secondary outcomes #2-13 in the order listed will proceed until a p-value >0.05 occurs.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
14.Secondary Outcome
Title 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
Hide Description

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

Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population of participants who took the first full dose of medication.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description:
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Overall Number of Participants Analyzed 102 102
Mean (Standard Deviation)
Unit of Measure: units on a scale
Minutes post dose: 2 -0.1  (0.26) -0.2  (0.33)
Minutes post dose: 4 -0.3  (0.62) -0.4  (0.69)
Minutes post dose: 6 -0.6  (1.05) -0.8  (1.14)
Minutes post dose: 8 -0.9  (1.56) -1.2  (1.60)
Minutes post dose: 10 -1.4  (2.10) -1.6  (2.11)
Minutes post dose: 12 -1.9  (2.68) -2.1  (2.59)
Minutes post dose: 14 -2.4  (3.30) -2.5  (3.08)
Minutes post dose: 16 -3.0  (3.94) -2.9  (3.56)
Minutes post dose: 18 -3.5  (4.56) -3.3  (4.01)
Minutes post dose: 20 -4.1  (5.19) -3.7  (4.47)
Minutes post dose: 22 -4.7  (5.83) -4.1  (4.95)
Minutes post dose: 24 -5.2  (6.46) -4.5  (5.43)
Minutes post dose: 26 -5.9  (7.12) -4.9  (5.69)
Minutes post dose: 28 -6.5  (7.76) -5.3  (6.37)
Minutes post dose: 30 -7.2  (8.41) -5.8  (6.87)
Minutes post dose: 32 -7.9  (9.09) -6.2  (7.36)
Minutes post dose: 34 -8.6  (9.77) -6.6  (7.87)
Minutes post dose: 36 -9.3  (10.45) -7.1  (8.37)
Minutes post dose: 38 -10.1  (11.14) -7.5  (8.87)
Minutes post dose: 40 -10.8  (11.80) -7.9  (9.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 2
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1448
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.0 to 0.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1538
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.0 to 0.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1407
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.1 to 0.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2906
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.2 to 0.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4758
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.4 to 0.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6975
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.6 to 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 14
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9370
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.8 to 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8493
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-1.1 to 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 18
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6732
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-1.4 to 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 20
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5414
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.8 to 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 22
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4313
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-2.1 to 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3501
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-2.4 to 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 26
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2679
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -1.0
Confidence Interval (2-Sided) 95%
-2.8 to 0.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 28
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2137
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-3.2 to 0.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 30
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1715
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-3.6 to 0.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 32
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1340
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -1.8
Confidence Interval (2-Sided) 95%
-4.1 to 0.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 34
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1030
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-4.5 to 0.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 36
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0788
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-5.0 to 0.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 38
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0620
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-5.5 to 0.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments Minutes post dose: 40
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0476
Comments [Not Specified]
Method ANOVA
Comments Baseline STPIS fitted as a covariate
Method of Estimation Estimation Parameter least-square means difference
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-6.0 to -0.0
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Kaplan-Meier Estimates for Sore Throat Pain Intensity Scale (STPIS) Time to Definite Improvement
Hide Description

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.

Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population of participants who completed the Definite Improvement Level (DIL) following study completion.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description:
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Overall Number of Participants Analyzed 58 61
Median (95% Confidence Interval)
Unit of Measure: minutes
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Too few participants reached DIL within 2 hours
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0273
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
16.Secondary Outcome
Title Kaplan-Meier Estimates for Sore Throat Pain Intensity Scale (STPIS) Time to Definite Improvement Duration of Relief Using Participant-Defined Definite Improvement Levels (DIL)
Hide Description

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.

Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population of participants who completed the Definite Improvement Level (DIL) following study completion.
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description:
Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
Overall Number of Participants Analyzed 58 61
Mean (Standard Deviation)
Unit of Measure: minutes
75.2  (102.41) 29.4  (65.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Flurbiprofen 8.75 mg Lozenge, Placebo Lozenge
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0098
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Initial dose up to Day 7
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Hide Arm/Group Description Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days. Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
All-Cause Mortality
Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Affected / at Risk (%) Affected / at Risk (%)
Total   0/102 (0.00%)   0/102 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Flurbiprofen 8.75 mg Lozenge Placebo Lozenge
Affected / at Risk (%) Affected / at Risk (%)
Total   36/102 (35.29%)   33/102 (32.35%) 
Ear and labyrinth disorders     
Tinnitis  1  1/102 (0.98%)  0/102 (0.00%) 
Conjunctivitis  1  1/102 (0.98%)  1/102 (0.98%) 
Ocular hyperaemia  1  1/102 (0.98%)  0/102 (0.00%) 
Abnormal sensation in eye  1  0/102 (0.00%)  1/102 (0.98%) 
Gastrointestinal disorders     
Abdominal pain upper  1  3/102 (2.94%)  0/102 (0.00%) 
Aphthous stomatitis  1  3/102 (2.94%)  2/102 (1.96%) 
Oral pain  1  3/102 (2.94%)  0/102 (0.00%) 
Nausea  1  2/102 (1.96%)  5/102 (4.90%) 
Stomatitis  1  2/102 (1.96%)  1/102 (0.98%) 
Chelilitis  1  1/102 (0.98%)  0/102 (0.00%) 
Gingivitis  1  1/102 (0.98%)  0/102 (0.00%) 
Oral discomfort  1  1/102 (0.98%)  0/102 (0.00%) 
Constipation  1  0/102 (0.00%)  1/102 (0.98%) 
Diarrhoea  1  0/102 (0.00%)  1/102 (0.98%) 
Dry mouth  1  0/102 (0.00%)  1/102 (0.98%) 
Gingival swelling  1  0/102 (0.00%)  1/102 (0.98%) 
Glossitis  1  0/102 (0.00%)  1/102 (0.98%) 
Glossodynia  1  0/102 (0.00%)  1/102 (0.98%) 
Sensitivity of teeth  1  0/102 (0.00%)  1/102 (0.98%) 
Vomiting  1  0/102 (0.00%)  1/102 (0.98%) 
General disorders     
Fatigue  1  1/102 (0.98%)  0/102 (0.00%) 
Chills  1  0/102 (0.00%)  1/102 (0.98%) 
Pain  1  0/102 (0.00%)  3/102 (2.94%) 
Pyrexia  1  0/102 (0.00%)  2/102 (1.96%) 
Infections and infestations     
Tonsillitis  1  4/102 (3.92%)  3/102 (2.94%) 
Otitis media  1  3/102 (2.94%)  0/102 (0.00%) 
Bronchitis  1  1/102 (0.98%)  1/102 (0.98%) 
Sinusitis  1  0/102 (0.00%)  1/102 (0.98%) 
Injury, poisoning and procedural complications     
Bite  1  1/102 (0.98%)  1/102 (0.98%) 
Corneal abrasion  1  0/102 (0.00%)  1/102 (0.98%) 
Musculoskeletal and connective tissue disorders     
Joint stiffness  1  1/102 (0.98%)  0/102 (0.00%) 
Muscle twitching  1  1/102 (0.98%)  0/102 (0.00%) 
Back pain  1  0/102 (0.00%)  1/102 (0.98%) 
Nervous system disorders     
Paraesthesia  1  4/102 (3.92%)  0/102 (0.00%) 
Headache  1  3/102 (2.94%)  6/102 (5.88%) 
Paraesthesia oral  1  2/102 (1.96%)  0/102 (0.00%) 
Somnolence  1  1/102 (0.98%)  1/102 (0.98%) 
Migraine  1  0/102 (0.00%)  1/102 (0.98%) 
Sinus headache  1  0/102 (0.00%)  1/102 (0.98%) 
Respiratory, thoracic and mediastinal disorders     
Throat irritation  1  3/102 (2.94%)  0/102 (0.00%) 
Cough  1  2/102 (1.96%)  2/102 (1.96%) 
Epistaxis  1  2/102 (1.96%)  1/102 (0.98%) 
Nasal congestion  1  1/102 (0.98%)  1/102 (0.98%) 
Nasal dryness  1  1/102 (0.98%)  0/102 (0.00%) 
Oropharyngeal swelling  1  1/102 (0.98%)  0/102 (0.00%) 
Rhinorrhoea  1  1/102 (0.98%)  0/102 (0.00%) 
Sneezing  1  1/102 (0.98%)  0/102 (0.00%) 
Dysphonia  1  0/102 (0.00%)  1/102 (0.98%) 
Dyspnoea  1  0/102 (0.00%)  1/102 (0.98%) 
Increased upper airway secretion  1  0/102 (0.00%)  1/102 (0.98%) 
Respiratory tract congestion  1  0/102 (0.00%)  1/102 (0.98%) 
Wheezing  1  0/102 (0.00%)  1/102 (0.98%) 
Skin and subcutaneous tissue disorders     
Cold sweat  1  1/102 (0.98%)  0/102 (0.00%) 
Urticaria  1  1/102 (0.98%)  0/102 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gail Solomon, Director, Clinical Development
Organization: Reckitt Benckiser Inc.
Phone: 973-404-2752
EMail: gail.solomon@rb.com
Publications of Results:
Schachtel BP, McCormick CG and Giefer EE. Patient-reported outcomes (PRO's) in the pharyngitis pain model. Abstract presented at the International Association for the Study of Pain (IASP) Scientific Conference, Montreal, Canada. 2009
Schachtel BP, Aspley S, Sternberg M, Berry P, Muir N, Sanner K, Rezuke J, Savino L, Shephard A, Shea T, Schachtel E. Onset of demulcent and analgesic activity of flurbiprofen lozenge. Int J Clin Pharm 2012;34:143-258.
Aspley S, Schachtel B, Berry P, Shephard A, Sanner K, Shea T, Smith G. The Chief Complaint: evidence of its use as an endpoint in a clinical trial. Journal of Pain 2012;13(4)Supplement:S4.
Aspley S, Schachtel B, Berry P, Shephard A, Sanner K, Savino L, Rezuke J, Shea T, Smith G. Treatment of odynophagia and dysphagia by flurbiprofen 8.75 mg lozenges. Pain Research & Management 2012;17(3):203.
Schachtel B, Aspley S, Berry P, Shephard A, Shea T,Sanner K, Smith G,Schachtel E. Efficacy of flurbiprofen 8.75mg lozenges in patients with swollen/inflamed sore throat. Abstract presented at the 14th World Congress on Pain, 27 - 31 August 2012, Milan.
Schachtel B, Aspley S, Berry P, Smith G, Shephard A, Shea T, Schachtel E. A patient-centered method for determining onset of action. Clinical Pharmacology in Drug Development 2012;1(4):194-195.
Schachtel B, Aspley S, Berry P, Shephard A, Shea T, Smith G, Sanner K, Savino L, Rezuke J, Schachtel E. Efficacy and duration of flurbiprofen 8.75 mg lozenge. Clinical Pharmacology in Drug Development 2012;1(4):194.
Schachtel B, Aspley S, Berry P, Shephard A, Shea T, Smith G, Schachtel E. A new cough model: de-hawthornizing a clinical trial. Clinical Pharmacology in Drug Development 2012;1(4):195.
Schachtel B, Aspley S, Berry P, Shephard A, Sanner K, Shea T, Smith G, Schachtel E. Chief Complaint: the therapeutogenic stimulus as the primary, individualized endpoint in clinical trials. Journal of Pain 2012;13(4)Supplement:S6.
Aspley S, Schachtel B, Berry P, Shephard A, Shea T, Smith G, Schachtel E. Flurbiprofen lozenges in patients with a "bad sore throat". Journal of Pain 2013;14(4):S59.
Schachtel B, Aspley S, Berry P, Shephard A, Shea T, Smith G, Schachtel E. The "Definite Improvement Level" (DIL) as a determinant of drug efficacy. Journal of Pain 2013;14(4):S5.
Shephard A, Smith G, Aspley S, Schachtel B. Efficacy of flurbiprofen 8.75 mg lozenges for streptococcal and non-streptococcal sore throat: pooled analysis of two randomised, placebo-controlled studies. Abstract presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), 27 - 30 April 2013, Berlin.
Shephard A, Smith G, Aspley S, Schachtel B. Symptomatic relief in streptococcal and non-streptococcal sore throat patients: pooled analysis of two randomised, placebo-controlled studies. Abstract presented at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), 27-30 April 2013, Berlin.
Layout table for additonal information
Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT01049334    
Other Study ID Numbers: TH 0901
First Submitted: January 13, 2010
First Posted: January 14, 2010
Results First Submitted: June 30, 2015
Results First Posted: September 21, 2017
Last Update Posted: September 21, 2017