Ibuprofen Lozenge in Acute Sore Throat Pain

June 26, 2013 updated by: Pierre Fabre Medicament

Study of Efficacy and Safety of V0498 Versus Placebo in Acute Sore Throat Pain.

The purpose of this study is to evaluate the efficacy and safety of repeated doses of a low dosage of oromucosal Ibuprofen form (lozenge) versus placebo in patients suffering from acute sore throat pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

427

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Gières, France
  • Germany
      • Erfurt, Germany
  • Latvia
      • Balvi, Latvia
      • Daugavpils, Latvia
      • Jekabpils, Latvia
      • Jelgava, Latvia
      • Kuldiga, Latvia
      • Liepaja, Latvia
      • Ogre, Latvia
      • Ogres Municipality, Latvia
      • Riga, Latvia
      • Saldus, Latvia
  • United Kingdom
      • Cardiff, United Kingdom
      • Glasgow, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male or female aged at least 18 years old
  • patient with an acute sore throat

Exclusion Criteria:

  • Severe respiratory tract infection (pneumonia, bronchitis or laryngitis)
  • Oro-pharyngeal paresthesia or mycosis
  • Severely traumatised and/or very severe oromucosal inflammation
  • Tonsillopharyngectomy
  • Peritonsillar abscess
  • Hypersensitivity to ibuprofen or other NonSteroidal Anti-Inflammatory Drugs (NSAIDs) (including bronchospasm) or to excipients
  • Long term use (≥ 3 times per week within the last month or regular intake within the last 3 months before randomisation) of antiinflammatory drugs- Any long-acting or slow release analgesic intake including NonSteroidal Anti-Inflammatory Drugs (NSAIDs)within 24 hours before randomisation (e.g. piroxicam or naproxen)
  • Any anti-inflammatory drugs intake by systemic route within 12 hours before randomisation
  • Any paracetamol intake within 6 hours before randomisation
  • Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomisation
  • Any topical throat medication intake containing or not a local oral anaesthetic such as lozenge, spray, mouth rinse within 4 hours before randomisation
  • Heavy smokers (>20 cigarettes/day)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Lozenge matching V0498 lozenge, Oromucosal administration
Experimental: Drug
V0498, Ibuprofen 25 mg
Drug: Ibuprofen 25 mg
Lozenge, Oromucosal administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Pain relief over 2 hours
Time Frame: 0-2 hours post-dose
Total Pain Relief (TOTPAR) assessed on a 7-point rating scale called the Sore Throat Relief Scale (STRS) over 120min after the start of sucking of 1st study drug administered
0-2 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medicament

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

June 27, 2013

Last Update Submitted That Met QC Criteria

June 26, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V00498 TA 3 01
  • 2012-004423-20 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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