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Ibuprofen Lozenge in Acute Sore Throat Pain

Primary Purpose

Acute Sore Throat Pain

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ibuprofen 25 mg
Placebo
Sponsored by
Pierre Fabre Medicament
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Sore Throat Pain focused on measuring sore throat pain, tonsillopharyngitis, upper respiratory tract infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drug

Placebo

Arm Description

V0498, Ibuprofen 25 mg

Placebo

Outcomes

Primary Outcome Measures

Total Pain relief over 2 hours
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

Secondary Outcome Measures

Full Information

First Posted
February 5, 2013
Last Updated
June 26, 2013
Sponsor
Pierre Fabre Medicament
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1. Study Identification

Unique Protocol Identification Number
NCT01785862
Brief Title
Ibuprofen Lozenge in Acute Sore Throat Pain
Official Title
Study of Efficacy and Safety of V0498 Versus Placebo in Acute Sore Throat Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Medicament

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Sore Throat Pain
Keywords
sore throat pain, tonsillopharyngitis, upper respiratory tract infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
427 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug
Arm Type
Experimental
Arm Description
V0498, Ibuprofen 25 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 25 mg
Intervention Description
Lozenge, Oromucosal administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Lozenge matching V0498 lozenge, Oromucosal administration
Primary Outcome Measure Information:
Title
Total Pain relief over 2 hours
Description
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
Time Frame
0-2 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
City
Gières
Country
France
City
Erfurt
Country
Germany
City
Balvi
Country
Latvia
City
Daugavpils
Country
Latvia
City
Jekabpils
Country
Latvia
City
Jelgava
Country
Latvia
City
Kuldiga
Country
Latvia
City
Liepaja
Country
Latvia
City
Ogres Municipality
Country
Latvia
City
Ogre
Country
Latvia
City
Riga
Country
Latvia
City
Saldus
Country
Latvia
City
Cardiff
Country
United Kingdom
City
Glasgow
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28869722
Citation
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.
Results Reference
derived

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Ibuprofen Lozenge in Acute Sore Throat Pain

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