A Single-Dose, Randomized, Double-Blind, Placebo-Controlled Onset-of-Action Study Utilizing the Double-Stopwatch Method

Reckitt Benckiser LLC1 site in 1 country122 target enrollmentSeptember 2013

ConditionsAcute Pharyngitis Sore Throat

Interventionsflurbiprofen placebo

Drugsflurbiprofen placebo

Overview

Phase: Phase 3
Intervention: flurbiprofen
Conditions: Acute Pharyngitis
Sponsor: Reckitt Benckiser LLC
Enrollment: 122
Locations: 1
Primary Endpoint: Kaplan-Meier Estimates for Time to Meaningful Pain Relief
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

April 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Reckitt Benckiser LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•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).

Exclusion Criteria

•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.
•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.

Arms & Interventions

flurbiprofen 8.75 mg lozenge

A single flurbiprofen lozenge is sucked until fully dissolved.

Intervention: flurbiprofen

Placebo lozenge

A single placebo lozenge is sucked until fully dissolved.

Intervention: placebo

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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)(Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1)
Percentage of Participants With Meaningful Pain Relief(up to 3 hours post dose on Day 1)
Percentage of Participants With Perceived Pain Relief(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)(Baseline (Day 1, pre-dose), 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(up to 3 hours post dose on Day 1)
Kaplan-Meier Estimates for Time of First Perceived Pain Relief(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)(up to 3 hours post dose on Day 1)
Change From Baseline at Individual Timepoints in Sore Throat Scale (STS)(Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1)