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The study's purpose is to demonstrate the onset of action, i.e., time to meaningful pain relief in patients with pharyngitis, of flurbiprofen 8.75 mg lozenge using the Double-Stopwatch Method (DSW).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| flurbiprofen 8.75 mg lozenge | Experimental | A single flurbiprofen lozenge is sucked until fully dissolved. |
|
| Placebo lozenge | Placebo Comparator | A single placebo lozenge is sucked until fully dissolved. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flurbiprofen | Drug | A single flurbiprofen 8.75 mg lozenge which also contains 1 mg of menthol in its vehicle base for flavour and taste purposes (blinding). Lozenge is sucked until dissolved, and not chewed, bit or swallowed. |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Estimates for Time to Meaningful Pain Relief | Time to meaningful pain relief is a patient-reported outcome (PRO) captured as part of the double stopwatch method. Participants depress the second stop watch when they experience what they perceive as meaningful pain relief. Instructions to participants are: "Stop the second stopwatch when the sore throat pain relief is meaningful to you. This does not mean you feel completely better, although you might, but when you feel relief of throat pain that is meaningful to you." Participants who did not have perceived pain relief were censored at 3 hours. | up to 3 hours post dose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Estimates for Time of First Perceived Pain Relief | Time to first perceived pain relief is a patient-reported outcome (PRO) captured as part of the double stopwatch method. Participants depress the first stop watch when they experience any pain relief, termed "perceived pain relief". Instructions to participants are: "Stop the first stopwatch when you first feel any sore throat pain relief whatsoever. This does not mean you feel completely better, although you might, but when you first feel any relief of the throat pain you have now." Participants who did not have perceived pain relief were censored at 3 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Shea, BS | Reckitt Benckiser Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut - Student Health Services | Storrs | Connecticut | 06269-4011 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29381110 | Derived | Schachtel B, Shephard A, Schachtel E, Lorton MB, Shea T, Aspley S. Qualities of Sore Throat Index (QuaSTI): measuring descriptors of sore throat in a randomized, placebo-controlled trial. Pain Manag. 2018 Mar;8(2):85-94. doi: 10.2217/pmt-2017-0041. Epub 2018 Jan 30. |
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133 patients were screened and 122 enrolled. Participants were randomly assigned in a 5:1 ratio to receive either an 8.75 mg flurbiprofen lozenge or a vehicle lozenge (placebo).
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| ID | Title | Description |
|---|---|---|
| FG000 | Flurbiprofen 8.75 mg Lozenge | A single flurbiprofen lozenge is sucked until fully dissolved. |
| FG001 | Placebo Lozenge | A single placebo lozenge is sucked until fully dissolved. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | Flurbiprofen 8.75 mg Lozenge | A single flurbiprofen lozenge is sucked until fully dissolved. |
| BG001 | Placebo Lozenge | A single placebo lozenge is sucked until fully dissolved. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Kaplan-Meier Estimates for Time to Meaningful Pain Relief | Time to meaningful pain relief is a patient-reported outcome (PRO) captured as part of the double stopwatch method. Participants depress the second stop watch when they experience what they perceive as meaningful pain relief. Instructions to participants are: "Stop the second stopwatch when the sore throat pain relief is meaningful to you. This does not mean you feel completely better, although you might, but when you feel relief of throat pain that is meaningful to you." Participants who did not have perceived pain relief were censored at 3 hours. | Intent to treat population | Posted | Median | 95% Confidence Interval | minutes | up to 3 hours post dose on Day 1 |
|
up to 20 hours post dose
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flurbiprofen 8.75 mg Lozenge | A single flurbiprofen lozenge is sucked until fully dissolved. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gail Solomon, Director, Clinical Development | Reckitt Benckiser Inc. | 973-404-2752 | gail.solomon@rb.com |
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| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D005480 | Flurbiprofen |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| placebo | Drug | A single placebo lozenge which also contains 1 mg of menthol in its vehicle base for flavour and taste purposes (blinding). Lozenge is sucked until dissolved, and not chewed, bit or swallowed. |
|
| up to 3 hours post dose on Day 1 |
| Kaplan-Meier Estimates for Time to First Perceived Pain Relief That Is Confirmed By Meaningful Pain Relief | Time to first perceived pain relief on the first stopwatch that was confirmed by meaningful pain relief on the second stopwatch. Participants who had no meaningful pain relief within 3 hours from baseline were censored to 3 hours. | up to 3 hours post dose on Day 1 |
| Kaplan-Meier Estimates for Time of First Indication of Sore Throat Relief as Measured By Any Reduction in the Sore Throat Scale (STS) | Time to first indication of sore throat relief, defined as any reduction or decrease in STS observed during the 3 hours post dose. Participants who did not have any reduction in STS from baseline within 3 hours were censored to 3 hours. The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: "Circle the number that shows how sore your throat is now when you swallow." The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours. | up to 3 hours post dose on Day 1 |
| Kaplan-Meier Estimates for Time of First Perceived Pain Reduction on the Sore Throat Scale (STS) Which is Followed by ≥ 20% Pain Reduction on the Sore Throat Pain Intensity Scale (STPIS) | Time to pain reduction on the STS (defined as any reduction or decrease observed during the 3 hours post dose) for participants whose improvement was confirmed by a >=20% reduction in pain on the STPIS. STS: The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: "Circle the number that shows how sore your throat is now when you swallow." The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours. STPIS: The participant was instructed to swallow and: "Place a line on the Sore Throat Scale that best characterizes the severity of your sore throat now:" 0mm=no pain and 100mm=severe pain. The STPIS was obtained at baseline, after the participant depressed the second stopwatch, and at 1, 2, and 3 hours postdose. | Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1 |
| Change From Baseline at Individual Timepoints in Sore Throat Scale (STS) | The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: "Circle the number that shows how sore your throat is now when you swallow." The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours. | Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1 |
| Percentage of Participants With Meaningful Pain Relief | Defined as the percentage of participants who pressed the second stopwatch during the 3 hour evaluation period. | up to 3 hours post dose on Day 1 |
| Percentage of Participants With Perceived Pain Relief | Defined as the percentage of participants who pressed the first stopwatch during the 3 hour evaluation period. | up to 3 hours post dose on Day 1 |
| Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Scale (STS) Over the 3 Hours Post-baseline (STS SPID3) | The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: "Circle the number that shows how sore your throat is now when you swallow." STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours, for a total of 24 post-dose measurements. The time-weighted SPID combines relief magnitude (PID = change from baseline) as weighted by duration interval between ratings. SPID3 refers to measurements taken up to 3 hours post-baseline, and has a full range of -1332 (complete pain relief within 5 minutes of dosing that lasts for 3 hours) to 468 (drug escalates level of pain to a score of 10 and the pain stays at that level for 3 hours) using the mean baseline STS value 7.4 for this study. | Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Primary Race | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | pounds |
|
| Height | Mean | Standard Deviation | inches |
|
| Sore Throat Scale (STS) Score | The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: "Circle the number that shows how sore your throat is now when you swallow." | Mean | Standard Deviation | units on a scale |
|
| Sore Throat Pain Intensity Scale (STPIS) | The participant was instructed to swallow and: "Place a line on the Sore Throat Scale that best characterizes the severity of your sore throat now:" 0mm=no pain and 100mm=severe pain. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Placebo Lozenge | A single placebo lozenge is sucked until fully dissolved. |
|
|
| Secondary | Kaplan-Meier Estimates for Time of First Perceived Pain Relief | Time to first perceived pain relief is a patient-reported outcome (PRO) captured as part of the double stopwatch method. Participants depress the first stop watch when they experience any pain relief, termed "perceived pain relief". Instructions to participants are: "Stop the first stopwatch when you first feel any sore throat pain relief whatsoever. This does not mean you feel completely better, although you might, but when you first feel any relief of the throat pain you have now." Participants who did not have perceived pain relief were censored at 3 hours. | Intent to treat | Posted | Median | 95% Confidence Interval | minutes | up to 3 hours post dose on Day 1 |
|
|
|
| Secondary | Kaplan-Meier Estimates for Time to First Perceived Pain Relief That Is Confirmed By Meaningful Pain Relief | Time to first perceived pain relief on the first stopwatch that was confirmed by meaningful pain relief on the second stopwatch. Participants who had no meaningful pain relief within 3 hours from baseline were censored to 3 hours. | Intent to treat | Posted | Median | 95% Confidence Interval | minutes | up to 3 hours post dose on Day 1 |
|
|
|
| Secondary | Kaplan-Meier Estimates for Time of First Indication of Sore Throat Relief as Measured By Any Reduction in the Sore Throat Scale (STS) | Time to first indication of sore throat relief, defined as any reduction or decrease in STS observed during the 3 hours post dose. Participants who did not have any reduction in STS from baseline within 3 hours were censored to 3 hours. The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: "Circle the number that shows how sore your throat is now when you swallow." The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours. | Intent to treat | Posted | Median | 95% Confidence Interval | minutes | up to 3 hours post dose on Day 1 |
|
|
|
| Secondary | Kaplan-Meier Estimates for Time of First Perceived Pain Reduction on the Sore Throat Scale (STS) Which is Followed by ≥ 20% Pain Reduction on the Sore Throat Pain Intensity Scale (STPIS) | Time to pain reduction on the STS (defined as any reduction or decrease observed during the 3 hours post dose) for participants whose improvement was confirmed by a >=20% reduction in pain on the STPIS. STS: The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: "Circle the number that shows how sore your throat is now when you swallow." The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours. STPIS: The participant was instructed to swallow and: "Place a line on the Sore Throat Scale that best characterizes the severity of your sore throat now:" 0mm=no pain and 100mm=severe pain. The STPIS was obtained at baseline, after the participant depressed the second stopwatch, and at 1, 2, and 3 hours postdose. | Intent to treat | Posted | Median | 95% Confidence Interval | minutes | Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1 |
|
|
|
| Secondary | Change From Baseline at Individual Timepoints in Sore Throat Scale (STS) | The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: "Circle the number that shows how sore your throat is now when you swallow." The STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours. | Intent to treat | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1 |
|
|
|
| Secondary | Percentage of Participants With Meaningful Pain Relief | Defined as the percentage of participants who pressed the second stopwatch during the 3 hour evaluation period. | Intent to treat | Posted | Number | 95% Confidence Interval | percentage of participants | up to 3 hours post dose on Day 1 |
|
|
|
| Secondary | Percentage of Participants With Perceived Pain Relief | Defined as the percentage of participants who pressed the first stopwatch during the 3 hour evaluation period. | Intent to treat | Posted | Number | 95% Confidence Interval | percentage of participants | up to 3 hours post dose on Day 1 |
|
|
|
| Secondary | Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Scale (STS) Over the 3 Hours Post-baseline (STS SPID3) | The participant was asked to evaluate his/her sore throat when swallowing using a vertical 0-10 Likert scale, where 0=not sore and 10=very sore. The participant was instructed: "Circle the number that shows how sore your throat is now when you swallow." STS was obtained at baseline, every 5 minutes after treatment during the first hour and every 10 minutes during the second and third hours, for a total of 24 post-dose measurements. The time-weighted SPID combines relief magnitude (PID = change from baseline) as weighted by duration interval between ratings. SPID3 refers to measurements taken up to 3 hours post-baseline, and has a full range of -1332 (complete pain relief within 5 minutes of dosing that lasts for 3 hours) to 468 (drug escalates level of pain to a score of 10 and the pain stays at that level for 3 hours) using the mean baseline STS value 7.4 for this study. | Intent to treat | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1 |
|
|
|
| 0 |
| 101 |
| 10 |
| 101 |
| EG001 | Placebo Lozenge | A single placebo lozenge is sucked until fully dissolved. | 0 | 21 | 1 | 21 |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (15.1) | Systematic Assessment |
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| Conjunctivitis infective | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
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The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D001713 |
| Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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