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

NCT01986361 | Completed Phase 3 Results

• 1 other identifier: 2012-STR-01
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Pharyngitis; Sore Throat

Keywords

Pharyngitis; Sore Throat; acute upper respiratory tract infection (URTI)

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 3 hours post dose on Day 1

Secondary Outcomes (8)

• Kaplan-Meier Estimates for Time of First Perceived Pain Relief

  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 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

• 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

• 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

Study Arms (2)

flurbiprofen 8.75 mg lozenge

EXPERIMENTAL

A single flurbiprofen lozenge is sucked until fully dissolved.

Drug: flurbiprofen

Placebo lozenge

PLACEBO COMPARATOR

A single placebo lozenge is sucked until fully dissolved.

Drug: placebo

Interventions

flurbiprofen DRUG

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.

flurbiprofen 8.75 mg lozenge

placebo DRUG

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.

Placebo lozenge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Reckitt Benckiser LLC: lead

Study Sites (1)

University of Connecticut - Student Health Services

Storrs, Connecticut, 06269-4011, United States

Location

Related Publications (1)

• 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.

  PMID: 29381110 DERIVED

MeSH Terms

Conditions

Pharyngitis

Interventions

Flurbiprofen

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Gail Solomon, Director, Clinical Development
• Organization: Reckitt Benckiser Inc.

gail.solomon@rb.com

973-404-2752

Study Officials

• Timothy Shea, BS

  Reckitt Benckiser Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: November 18, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 28, 2017
• Results First Posted: August 24, 2017

Record last verified: 2017-08

Locations

US (1)