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Placebo-Controlled Onset-of-Action Study of Flurbiprofen Utilizing the Double-Stopwatch Method

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ClinicalTrials.gov Identifier: NCT01986361
Recruitment Status : Completed
First Posted : November 18, 2013
Results First Posted : August 24, 2017
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Acute Pharyngitis Sore Throat Drug: flurbiprofen Drug: placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Dose, Randomized, Double-Blind, Placebo-Controlled Onset-of-Action Study Utilizing the Double-Stopwatch Method
Study Start Date : September 2013
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: flurbiprofen 8.75 mg lozenge
A single flurbiprofen lozenge is sucked until fully dissolved.
Drug: flurbiprofen
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.
Placebo Comparator: Placebo lozenge
A single placebo lozenge is sucked until fully dissolved.
Drug: placebo
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Kaplan-Meier Estimates for Time of First Perceived Pain Relief [ Time Frame: up to 3 hours post dose on Day 1 ]
    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.

  2. 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 ]
    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.

  3. 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 ]

    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.


  4. 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 ]

    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.


  5. 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 ]
    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.

  6. Percentage of Participants With Meaningful Pain Relief [ Time Frame: up to 3 hours post dose on Day 1 ]
    Defined as the percentage of participants who pressed the second stopwatch during the 3 hour evaluation period.

  7. Percentage of Participants With Perceived Pain Relief [ Time Frame: up to 3 hours post dose on Day 1 ]
    Defined as the percentage of participants who pressed the first stopwatch during the 3 hour evaluation period.

  8. 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 ]

    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.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986361


Locations
United States, Connecticut
University of Connecticut - Student Health Services
Storrs, Connecticut, United States, 06269-4011
Sponsors and Collaborators
Reckitt Benckiser LLC
Investigators
Study Director: Timothy Shea, BS Reckitt Benckiser LLC
More Information

Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT01986361     History of Changes
Other Study ID Numbers: 2012-STR-01
First Posted: November 18, 2013    Key Record Dates
Results First Posted: August 24, 2017
Last Update Posted: September 28, 2017
Last Verified: August 2017

Keywords provided by Reckitt Benckiser LLC:
Pharyngitis
Sore Throat
acute upper respiratory tract infection (URTI)

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Flurbiprofen
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action