Ibuprofen Lozenge in Acute Sore Throat Pain

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ClinicalTrials.gov Identifier: NCT01785862

Recruitment Status : Completed

First Posted : February 7, 2013

Last Update Posted : June 27, 2013

Sponsor:

Information provided by (Responsible Party):

Pierre Fabre Medicament

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Acute Sore Throat Pain	Drug: Ibuprofen 25 mg Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	427 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Study of Efficacy and Safety of V0498 Versus Placebo in Acute Sore Throat Pain.
Study Start Date :	February 2013
Actual Primary Completion Date :	June 2013
Actual Study Completion Date :	June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Drug Information available for: Ibuprofen Ibuprofen sodium Ibuprofen lysine Midol

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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

Criteria

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)

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): NCT01785862

Locations

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France

Gières, France
Germany

Erfurt, Germany
Latvia

Balvi, Latvia

Daugavpils, Latvia

Jekabpils, Latvia

Jelgava, Latvia

Kuldiga, Latvia

Liepaja, Latvia

Ogres Municipality, Latvia

Ogre, Latvia

Riga, Latvia

Saldus, Latvia
United Kingdom

Cardiff, United Kingdom

Glasgow, United Kingdom

Sponsors and Collaborators

Pierre Fabre Medicament

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bouroubi A, Donazzolo Y, Donath F, Eccles R, Russo M, Harambillet N, Gautier S, Montagne A. Pain relief of sore throat with a new anti-inflammatory throat lozenge, ibuprofen 25 mg: A randomised, double-blind, placebo-controlled, international phase III study. Int J Clin Pract. 2017 Sep;71(9). doi: 10.1111/ijcp.12961. Epub 2017 Sep 4.

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Responsible Party:	Pierre Fabre Medicament
ClinicalTrials.gov Identifier:	NCT01785862 History of Changes
Other Study ID Numbers:	V00498 TA 3 01 2012-004423-20 ( EudraCT Number )
First Posted:	February 7, 2013 Key Record Dates
Last Update Posted:	June 27, 2013
Last Verified:	June 2013

Keywords provided by Pierre Fabre Medicament:


sore throat pain tonsillopharyngitis upper respiratory tract infection

Additional relevant MeSH terms:

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

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