Acute PharyngitisPhase 3NCT01986361
Placebo-Controlled Onset-of-Action Study of Flurbiprofen Utilizing the Double-Stopwatch Method
A Phase 3 study testing flurbiprofen in people with Acute Pharyngitis and Sore Throat, run by Reckitt Benckiser LLC at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pharyngitis, Sore Throat
- What is being tested?
- flurbiprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Apr 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis: pharyngitis confirmed by a Tonsillo-Pharyngitis Assessment ≥ 5
- Complaint of sore throat with an onset ≤ 4 days prior to randomization
- Have at least one symptom of upper respiratory tract infection (URTI) on the URTI Questionnaire (e.g., sore throat, runny nose, cough, fever)
- Have moderate or severe sore throat pain on the Throat Pain Scale
- Have a baseline Sore Throat Scale (STS) ≥ 6
- If the patient is a female of childbearing potential, she has been using effective contraception since the last date of menses and is not breast-feeding or lactating. She is also willing to take adequate contraceptive precautions through 24 hours after the completion of the study.
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- If the patient is a female of childbearing potential, the patient must have a negative urine pregnancy test (UPT) result (indicating "not pregnant") obtained on the day of scheduled randomization, prior to the designated time of randomization
- The patient is willing to remain at the study centre for 3 hours after receiving the dose of study medication
- During the 3-hour evaluation of the study medication lozenge at the site, the patient is willing to take "nothing by mouth" (e.g., no smoking, food, candy, lozenges, chewing gum, liquids).
Who cannot join
- Known allergy and/or hypersensitivity to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), or any other inactive ingredients such as honey, lemon flavor, menthol, or sucrose.
- History of an upper gastrointestinal ulcer within the past 60 days, current clinically significant upper gastrointestinal complaints, or current regular use (≥ 3 times in the previous week) of any medication for upper gastrointestinal symptoms, including antacids, H2 blockers, proton pump inhibitors or sucralfate
- History of any hepatic disease or renal dysfunction
- Other severe acute or chronic medical condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
- History of chronic analgesic use (≥ 3 times per week over the prior 4 weeks)
- Use of an antibiotic for an acute disease within the previous 24 hours before randomization. (Chronic antibiotic use, such as for acne, is acceptable.) Use of any quinolone antibiotic such as ciprofloxacin or nalidixic acid within the past week or concurrently is specifically prohibited.
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- Use of mifepristone in the 12 days prior to the screening visit
- Use of inhaled therapy (e.g., inhaled steroids or β-agonists, such as Ventolin) on an acute basis for disease exacerbation in the week prior to the screening visit
- Use of any immediate release analgesic within 4 hours preceding administration of the study medication.
- Use of any sustained release analgesic within 12 hours preceding administration of the study medication.
- Use of any "cold medication" (i.e. decongestants, antihistamines, expectorants, antitussives) within 4 hours preceding administration of the dose of study medication.
- Use of any throat lozenge, throat spray, cough drop, or menthol-containing product within 2 hours preceding administration of the study medication
- Consumption of any caffeine-containing beverage (e.g., coffee, tea, hot chocolate, caffeinated soft drinks) within 5 minutes preceding administration of the study medication.
- Any evidence of mouth-breathing (which could worsen sore throat pain).
- Coughing that causes throat discomfort or any active physical disease (such as bronchopneumonia) which could compromise respiratory function and worsen a sore throat
- Unable in the opinion of the Investigator to comply fully with the study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut - Student Health Services
Storrs, Connecticut, 06269-4011
About this study
Official title: A Single-Dose, Randomized, Double-Blind, Placebo-Controlled Onset-of-Action Study Utilizing the Double-Stopwatch Method
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).
- Conditions
- Acute Pharyngitis, Sore Throat
- Being tested
- flurbiprofen, placebo
- Keywords
- Pharyngitis, Sore Throat, acute upper respiratory tract infection (URTI)
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flurbiprofenDrug
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.
placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| flurbiprofen 8.75 mg lozenge | Experimental | A single flurbiprofen lozenge is sucked until fully dissolved. Receives: Drug: flurbiprofen |
| Placebo lozenge | Placebo comparator | A single placebo lozenge is sucked until fully dissolved. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 hours post dose on Day 1
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PharyngitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Shea, BS, Study director, Reckitt Benckiser Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986361
- Sponsor's protocol ID
- 2012-STR-01
- Status last verified
- Aug 2017
- First submitted
- 22 Oct 2013
- Last updated
- 28 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29381110
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Randomized, Double-Blind, Placebo-Controlled Onset-of-Action Study Utilizing the Double-Stopwatch Method
- ClinicalTrials.gov ID
- NCT01986361
- Acronym / sponsor ID
- 2012-STR-01
- Conditions
- Acute Pharyngitis, Sore Throat
- Keywords
- Pharyngitis, Sore Throat, acute upper respiratory tract infection (URTI)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Reckitt Benckiser LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Posted 24 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flurbiprofen 8.75 mg lozenge | Experimental | Drug: flurbiprofenA single flurbiprofen lozenge is sucked until fully dissolved. |
| Placebo lozenge | Placebo comparator | Drug: placeboA single placebo lozenge is sucked until fully dissolved. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Primary diagnosis: pharyngitis confirmed by a Tonsillo-Pharyngitis Assessment ≥ 5
- Complaint of sore throat with an onset ≤ 4 days prior to randomization
- Have at least one symptom of upper respiratory tract infection (URTI) on the URTI Questionnaire (e.g., sore throat, runny nose, cough, fever)
- Have moderate or severe sore throat pain on the Throat Pain Scale
- Have a baseline Sore Throat Scale (STS) ≥ 6
Key exclusion criteria (16 listed)
- Known allergy and/or hypersensitivity to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), or any other inactive ingredients such as honey, lemon flavor, menthol, or sucrose.
- History of an upper gastrointestinal ulcer within the past 60 days, current clinically significant upper gastrointestinal complaints, or current regular use (≥ 3 times in the previous week) of any medication for upper gastrointestinal symptoms, including antacids, H2 blockers, proton pump inhibitors or sucralfate
- History of any hepatic disease or renal dysfunction
- Other severe acute or chronic medical condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
- History of chronic analgesic use (≥ 3 times per week over the prior 4 weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flurbiprofenA 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. | Drug | flurbiprofen 8.75 mg lozenge |
| placeboA 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. | Drug | Placebo lozenge |
Primary outcome
Kaplan-Meier Estimates for Time to Meaningful Pain Relief
Time frame: up to 3 hours post dose on Day 1
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.
8 secondary outcomes
Kaplan-Meier Estimates for Time of First Perceived Pain Relief
Time frame: 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 frame: 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 frame: 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 frame: 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)
Time frame: Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1
Percentage of Participants With Meaningful Pain Relief
Time frame: up to 3 hours post dose on Day 1
Percentage of Participants With Perceived Pain Relief
Time frame: 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)
Time frame: Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29381110Schachtel 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Shea, BS study director
Reckitt Benckiser Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing flurbiprofen in people with Acute Pharyngitis and Sore Throat, run by Reckitt Benckiser LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kaplan-Meier Estimates for Time to Meaningful Pain Relief (time frame: up to 3 hours post dose on Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01986361, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.