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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Reckitt Benckiser LLC
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser LLC
ClinicalTrials.gov Identifier:
NCT01986361
First received: October 22, 2013
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Acute Pharyngitis
Sore Throat
Drug: flurbiprofen
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Dose, Randomized, Double-Blind, Placebo-Controlled Onset-of-Action Study Utilizing the Double-Stopwatch Method

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser LLC:

Primary Outcome Measures:
  • Time to Meaningful Pain Relief [ Time Frame: up to 3 hours post dose ] [ Designated as safety issue: No ]
    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."


Secondary Outcome Measures:
  • Time of First Perceived Pain Relief [ Time Frame: up to 3 hours ] [ Designated as safety issue: No ]
    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."

  • Time of first perceived pain relief that is confirmed by meaningful pain relief [ Time Frame: up to 3 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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: up to 3 hours ] [ Designated as safety issue: No ]
  • Reduction of sore throat as measured by Sore Throat Scale (STS) at individual time points. [ Time Frame: up to 3 hours ] [ Designated as safety issue: No ]
  • Percentage of patients with meaningful pain relief [ Time Frame: up to 3 hours ] [ Designated as safety issue: No ]
  • Percentage of patients with perceived pain relief [ Time Frame: up to 3 hours ] [ Designated as safety issue: No ]
  • Weighted sum of differences on the Sore Throat Scale (STS) over 3 hours (SPID3) [ Time Frame: 3 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01986361

Contacts
Contact: Timothy J Shea, BS 973 404 2883 tim.shea@reckittbenckiser.com

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

No publications provided

Responsible Party: Reckitt Benckiser LLC
ClinicalTrials.gov Identifier: NCT01986361     History of Changes
Other Study ID Numbers: 2012-STR-01
Study First Received: October 22, 2013
Last Updated: November 11, 2013
Health Authority: United States: Food and Drug Administration

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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014