flurbiprofen has been researched along with Group A Strep Infection in 1 studies
Flurbiprofen: An anti-inflammatory analgesic and antipyretic of the phenylalkynoic acid series. It has been shown to reduce bone resorption in periodontal disease by inhibiting CARBONIC ANHYDRASE.
flurbiprofen : A monocarboxylic acid that is a 2-fluoro-[1,1'-biphenyl-4-yl] moiety linked to C-2 of propionic acid. A non-steroidal anti-inflammatory, analgesic and antipyretic, it is used as a pre-operative anti-miotic as well as orally for arthritis or dental pain.
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 1 (100.00) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors | Studies |
---|---|
Shephard, A | 1 |
Smith, G | 1 |
Aspley, S | 1 |
Schachtel, BP | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Randomized, Double-Blind, Placebo-Controlled Multiple-Dose Study to Determine the Efficacy, Onset, and Duration of Action of Flurbiprofen 8.75 mg Lozenge Compared to Its Vehicle Control Lozenge in Patients With Painful Pharyngitis[NCT01049334] | Phase 3 | 204 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
A Repeat-Dose, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Study to Determine the Safety and Efficacy of Flurbiprofen 8.75 mg Lozenge Compared to Its Vehicle Control Lozenge in Patients With Painful Pharyngitis[NCT01048866] | Phase 3 | 198 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
"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." (NCT01049334)
Timeframe: Baseline (pre-dose), 24 hours post-dose
Intervention | units on a scale (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -1.2 |
Placebo Lozenge | -2.0 |
"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." (NCT01049334)
Timeframe: 2 hours
Intervention | minutes (Median) |
---|---|
Flurbiprofen 8.75 mg Lozenge | NA |
Placebo Lozenge | NA |
"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." (NCT01049334)
Timeframe: 6 hours
Intervention | minutes (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | 75.2 |
Placebo Lozenge | 29.4 |
"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." (NCT01049334)
Timeframe: baseline (pre-dose), 2 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2)
Intervention | units on a scale (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -43.4 |
Placebo Lozenge | -23.5 |
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. (NCT01049334)
Timeframe: baseline (pre-dose), 24 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-24)
Intervention | units on a scale (Least Squares Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -473.7 |
Placebo Lozenge | -322.3 |
"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." (NCT01049334)
Timeframe: baseline (pre-dose), 24 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-24)
Intervention | units on a scale (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -451.4 |
Placebo Lozenge | -283.4 |
"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." (NCT01049334)
Timeframe: baseline (pre-dose), 2 hours post-dose (every 10 minutes until hour 2)
Intervention | units on a scale (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -39.1 |
Placebo Lozenge | -16.6 |
"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." (NCT01049334)
Timeframe: baseline (pre-dose), 24 hours post-dose (every 10 minutes until hour 2, every 30 minutes until hour 6, hourly from 7-24 hours)
Intervention | units on a scale (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -460.8 |
Placebo Lozenge | -274.3 |
"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." (NCT01049334)
Timeframe: baseline (pre-dose), 2 hours post-dose (at 1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, and 2 hours)
Intervention | units on a scale (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -39.9 |
Placebo Lozenge | -20.1 |
"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." (NCT01049334)
Timeframe: baseline (pre-dose), 24 hours post-dose (1 hour, 70 minutes, 80 minutes, 90 minutes, 100 minutes, 110 minutes, 2 hours, 2½ hours, 3 hours, 3½ hours, 4 hours, 4½ hours, 5 hours, 5½ hours, and 6 hours after the first dose, hourly from 7-24 hours)
Intervention | units on a scale (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -472.2 |
Placebo Lozenge | -355.2 |
"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." (NCT01049334)
Timeframe: 24 hours
Intervention | percentage of participants (Number) | ||||
---|---|---|---|---|---|
Poor | Fair | Good | Very Good | Excellent | |
Flurbiprofen 8.75 mg Lozenge | 15.8 | 34.7 | 19.8 | 13.9 | 15.8 |
Placebo Lozenge | 38.0 | 28.0 | 18.0 | 13.0 | 3.0 |
"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." (NCT01049334)
Timeframe: Day 7
Intervention | percentage of participants (Number) | ||||
---|---|---|---|---|---|
Poor | Fair | Good | Very Good | Excellent | |
Flurbiprofen 8.75 mg Lozenge | 11.8 | 28.0 | 30.1 | 17.2 | 12.9 |
Placebo Lozenge | 31.6 | 34.7 | 14.7 | 14.7 | 4.2 |
After 24 hours of treatment, participants rated their satisfaction with the treatment on a 7-step scale from extremely dissatisfied to extremely satisfied. (NCT01049334)
Timeframe: 24 hours
Intervention | percentage of participants (Number) | ||||||
---|---|---|---|---|---|---|---|
Extremely dissatisfied | Very dissatisfied | Dissatisfied | Somewhat satisfied | Satisfied | Very satisfied | Extremely satisfied | |
Flurbiprofen 8.75 mg Lozenge | 5.0 | 6.9 | 11.9 | 29.7 | 20.8 | 23.8 | 2.0 |
Placebo Lozenge | 10.0 | 20.0 | 14.0 | 28.0 | 17.0 | 9.0 | 2.0 |
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. (NCT01049334)
Timeframe: 24 hours post-dose
Intervention | participants (Number) | |||
---|---|---|---|---|
No inflammation | Mild inflammation | Moderate inflammation | Severe inflammation | |
Flurbiprofen 8.75 mg Lozenge | 0 | 48 | 42 | 11 |
Placebo Lozenge | 1 | 42 | 50 | 7 |
"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." (NCT01049334)
Timeframe: 2 hours
Intervention | percentage of participants (Number) | |||||
---|---|---|---|---|---|---|
No relief | Slight relief | Mild relief | Moderate relief | Considerable relief | Complete relief | |
Flurbiprofen 8.75 mg Lozenge | 18.6 | 23.5 | 23.5 | 20.6 | 13.7 | 0 |
Placebo Lozenge | 45.1 | 24.5 | 11.8 | 13.7 | 4.9 | 0 |
"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" (NCT01049334)
Timeframe: baseline (pre-dose), up to 23 hours post-dose (every 2 minutes for one hour; every 10 minutes until hour 2; every 30 minutes until hour 6; and every hour the participant was awake between hours 7-23)
Intervention | units on a scale (Mean) | |||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Minutes post dose: 2 | Minutes post dose: 4 | Minutes post dose: 6 | Minutes post dose: 8 | Minutes post dose: 10 | Minutes post dose: 12 | Minutes post dose: 14 | Minutes post dose: 16 | Minutes post dose: 18 | Minutes post dose: 20 | Minutes post dose: 22 | Minutes post dose: 24 | Minutes post dose: 26 | Minutes post dose: 28 | Minutes post dose: 30 | Minutes post dose: 32 | Minutes post dose: 34 | Minutes post dose: 36 | Minutes post dose: 38 | Minutes post dose: 40 | |
Flurbiprofen 8.75 mg Lozenge | -0.1 | -0.3 | -0.6 | -0.9 | -1.4 | -1.9 | -2.4 | -3.0 | -3.5 | -4.1 | -4.7 | -5.2 | -5.9 | -6.5 | -7.2 | -7.9 | -8.6 | -9.3 | -10.1 | -10.8 |
Placebo Lozenge | -0.2 | -0.4 | -0.8 | -1.2 | -1.6 | -2.1 | -2.5 | -2.9 | -3.3 | -3.7 | -4.1 | -4.5 | -4.9 | -5.3 | -5.8 | -6.2 | -6.6 | -7.1 | -7.5 | -7.9 |
(NCT01048866)
Timeframe: baseline (pre-dose), 2 hours post-dose
Intervention | degrees Fahrenheit (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -0.2 |
Placebo Lozenge | -0.0 |
(NCT01048866)
Timeframe: baseline (pre-dose), up to Day 7
Intervention | degrees Fahrenheit (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -0.4 |
Placebo Lozenge | -0.3 |
"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." (NCT01048866)
Timeframe: Days 2-7
Intervention | units on a scale (Least Squares Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -21.0 |
Placebo Lozenge | -15.5 |
"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." (NCT01048866)
Timeframe: Days 2-7
Intervention | units on a scale (Least Squares Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -19.5 |
Placebo Lozenge | -13.4 |
"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." (NCT01048866)
Timeframe: Days 2-7
Intervention | units on a scale (Least Squares Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -22.7 |
Placebo Lozenge | -16.8 |
"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." (NCT01048866)
Timeframe: baseline (pre-dose), post-dose: 1 hour, 2 hours
Intervention | units on a scale (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -37.1 |
Placebo Lozenge | -17.9 |
"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." (NCT01048866)
Timeframe: baseline (pre-dose), post-dose - hourly up to 24 hours
Intervention | units on a scale (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -522.9 |
Placebo Lozenge | -326.5 |
"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" (NCT01048866)
Timeframe: baseline (pre-dose), 24 hours post dose (measured each hour post dose)
Intervention | units on a scale (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -476.9 |
Placebo Lozenge | -351.3 |
"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." (NCT01048866)
Timeframe: Baseline (pre-dose), Hours 1 and 2 post-dose
Intervention | units on a scale (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -37.1 |
Placebo Lozenge | -18.1 |
"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." (NCT01048866)
Timeframe: Baseline (pre-dose), hourly readings to 24 hours post-dose
Intervention | units on a scale (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -555.5 |
Placebo Lozenge | -379.4 |
"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." (NCT01048866)
Timeframe: Baseline (pre-dose), hourly readings to 2 hours post-dose
Intervention | units on a scale (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -35.5 |
Placebo Lozenge | -16.9 |
"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." (NCT01048866)
Timeframe: Baseline (pre-dose), hourly readings to 24 hours post-dose
Intervention | units on a scale (Mean) |
---|---|
Flurbiprofen 8.75 mg Lozenge | -542.4 |
Placebo Lozenge | -377.4 |
"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." (NCT01048866)
Timeframe: 24 hours
Intervention | percentage of participants (Number) | ||||
---|---|---|---|---|---|
Poor | Fair | Good | Very Good | Excellent | |
Flurbiprofen 8.75 mg Lozenge | 25.0 | 27.0 | 26.0 | 14.0 | 8.0 |
Placebo Lozenge | 25.3 | 29.5 | 24.2 | 12.6 | 8.4 |
"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." (NCT01048866)
Timeframe: Day 7 (end of study)
Intervention | percentage of participants (Number) | ||||
---|---|---|---|---|---|
Poor | Fair | Good | Very Good | Excellent | |
Flurbiprofen 8.75 mg Lozenge | 19.8 | 22.9 | 24.0 | 26.0 | 7.3 |
Placebo Lozenge | 25.0 | 26.1 | 20.7 | 22.8 | 5.4 |
After 24 hours of treatment, participants rated their satisfaction with the treatment on a 7-step scale from extremely dissatisfied to extremely satisfied. (NCT01048866)
Timeframe: 24 hours
Intervention | percentage of participants (Number) | ||||||
---|---|---|---|---|---|---|---|
Extremely dissatisfied | Very dissatisfied | Dissatisfied | Somewhat satisfied | Satisfied | Very satisified | Extremely satisfied | |
Flurbiprofen 8.75 mg Lozenge | 4.0 | 4.0 | 10.9 | 27.7 | 23.8 | 24.8 | 5.0 |
Placebo Lozenge | 5.2 | 9.4 | 14.6 | 32.3 | 26.0 | 7.3 | 5.2 |
Participants were allowed a dose of rescue medication (acetaminophen 650mg), as needed, post-treatment dosing during the study. (NCT01048866)
Timeframe: Days 1-7
Intervention | percentage of participants (Number) | |
---|---|---|
Yes | No | |
Flurbiprofen 8.75 mg Lozenge | 13.9 | 86.1 |
Placebo Lozenge | 25.8 | 74.2 |
"Participants graded the relief of his/her sore throat at 2 hours after taking a lozenge for all lozenges taken after the initial 24-hours post-baseline using the Sore Throat Relief Rating Scale (STRRS), which is a 6-category relief scale.~The patient was instructed to swallow and:~Considering how your throat felt before you took the study medicine, circle the phrase that best describes the relief of your sore throat now. Responses following each lozenge were no relief, slight, mild, moderate, considerable, and complete relief. Results summarize responses 2 hours after taking each lozenge." (NCT01048866)
Timeframe: Days 2-7
Intervention | percentage of doses (Number) | |||||
---|---|---|---|---|---|---|
No relief | Slight relief | Mild relief | Moderate relief | Considerable relief | Complete relief | |
Flurbiprofen 8.75 mg Lozenge | 9.7 | 21.7 | 25.2 | 16.5 | 18.9 | 8.0 |
Placebo Lozenge | 23.0 | 24.8 | 19.0 | 13.7 | 14.7 | 4.9 |
"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." (NCT01048866)
Timeframe: 2 hours
Intervention | percentage of participants (Number) | ||||
---|---|---|---|---|---|
No relief | Slight relief | Mild relief | Moderate relief | Considerable relief | |
Flurbiprofen 8.75 mg Lozenge | 9.9 | 28.7 | 27.7 | 17.8 | 15.8 |
Placebo Lozenge | 38.1 | 22.7 | 17.5 | 18.6 | 3.1 |
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. (NCT01048866)
Timeframe: Days 1-7
Intervention | percentage of participants (Number) | |||||
---|---|---|---|---|---|---|
2 - <4 hours | 4 - <6 hours | 6 - <24 hours | 24 - <72 hours | 72 - 168 hours | Did not rescue | |
Flurbiprofen 8.75 mg Lozenge | 2.0 | 2.0 | 5.9 | 3.0 | 1.0 | 86.1 |
Placebo Lozenge | 6.2 | 2.1 | 13.4 | 3.1 | 1.0 | 74.2 |
1 trial available for flurbiprofen and Group A Strep Infection