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

NCT01986361 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2017-09-28

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • Reckitt Benckiser LLC

    lead INDUSTRY

Principal Investigators

  • Timothy Shea, BS · Reckitt Benckiser Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01986361 on ClinicalTrials.gov