NCT01785862

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
427

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_3

Geographic Reach
4 countries

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 27, 2013

Status Verified

June 1, 2013

Enrollment Period

4 months

First QC Date

February 5, 2013

Last Update Submit

June 26, 2013

Conditions

Acute Sore Throat Pain

Keywords

sore throat paintonsillopharyngitisupper respiratory tract infection

Outcome Measures

Primary Outcomes (1)

  • 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

    0-2 hours post-dose

Study Arms (2)

Drug

EXPERIMENTAL

V0498, Ibuprofen 25 mg

Drug: Ibuprofen 25 mg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Ibuprofen 25 mgDRUG

Lozenge, Oromucosal administration

Drug
PlaceboDRUG

Lozenge matching V0498 lozenge, Oromucosal administration

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Gières, France

Location

Unknown Facility

Erfurt, Germany

Location

Unknown Facility

Balvi, Latvia

Location

Unknown Facility

Daugavpils, Latvia

Location

Unknown Facility

Jelgava, Latvia

Location

Unknown Facility

Jēkabpils, Latvia

Location

Unknown Facility

Kuldīga, Latvia

Location

Unknown Facility

Liepāja, Latvia

Location

Unknown Facility

Ogre, Latvia

Location

Unknown Facility

Ogres Municipality, Latvia

Location

Unknown Facility

Riga, Latvia

Location

Unknown Facility

Saldus, Latvia

Location

Unknown Facility

Cardiff, United Kingdom

Location

Unknown Facility

Glasgow, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 28869722DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 7, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 27, 2013

Record last verified: 2013-06

Locations

DE(1)LA(10)GB(2)FR(1)