Clinical trial NCT01986361: Placebo-Controlled Onset-of-Action Study of Flurbiprofen Utilizing the Double-Stopwatch Method
Official title: A Single-Dose, Randomized, Double-Blind, Placebo-Controlled Onset-of-Action Study Utilizing the Double-Stopwatch Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pharyngitis
Sore Throat
Keywords: Pharyngitis
Sore Throat
acute upper respiratory tract infection (URTI)
Lead sponsor: Reckitt Benckiser LLC
Sponsor class: INDUSTRY
First posted: 2013-11-18
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.
* 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

Primary outcomes:
measure: Kaplan-Meier Estimates for Time to Meaningful Pain Relief
timeFrame: up to 3 hours post dose on Day 1
Secondary outcomes:
measure: Kaplan-Meier Estimates for Time of First Perceived Pain Relief
timeFrame: up to 3 hours post dose on Day 1
measure: Kaplan-Meier Estimates for Time to First Perceived Pain Relief That Is Confirmed By Meaningful Pain Relief
timeFrame: up to 3 hours post dose on Day 1
measure: Kaplan-Meier Estimates for Time of First Indication of Sore Throat Relief as Measured By Any Reduction in the Sore Throat Scale (STS)
timeFrame: up to 3 hours post dose on Day 1
measure: 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)
timeFrame: Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1
measure: Change From Baseline at Individual Timepoints in Sore Throat Scale (STS)
timeFrame: Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1
measure: Percentage of Participants With Meaningful Pain Relief
timeFrame: up to 3 hours post dose on Day 1
measure: Percentage of Participants With Perceived Pain Relief
timeFrame: up to 3 hours post dose on Day 1
measure: Time Weighted Sum of Pain Intensity Differences (SPID) in Sore Throat Scale (STS) Over the 3 Hours Post-baseline (STS SPID3)
timeFrame: Baseline (Day 1, pre-dose), up to 3 hours post dose on Day 1
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut - Student Health Services
state: Connecticut
Study officials:
affiliation: Reckitt Benckiser Inc.
name: Timothy Shea, BS
role: STUDY_DIRECTOR
References:
citation: 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.