Acute Sore Throat PainPhase 3NCT01785862
Ibuprofen Lozenge in Acute Sore Throat Pain
A Phase 3 study testing Ibuprofen 25 mg in people with Acute Sore Throat Pain, run by Pierre Fabre Medicament at 14 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Sore Throat Pain
- What is being tested?
- Ibuprofen 25 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 427 participants
- Where
- 14 sitesin 4 countries
- Study dates
- Feb 2013to Jun 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female aged at least 18 years old
- patient with an acute sore throat
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
Latvia10 sites
Study site
Balvi
Study site
Daugavpils
Study site
Jēkabpils
Study site
Jelgava
Study site
Kuldīga
Study site
Liepāja
Study site
Ogre
Study site
Ogres Municipality
Study site
Riga
Study site
Saldus
About this study
Official title: 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.
- Conditions
- Acute Sore Throat Pain
- Being tested
- Ibuprofen 25 mg, Placebo
- Keywords
- sore throat pain, tonsillopharyngitis, upper respiratory tract infection
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 25 mgDrug
Lozenge, Oromucosal administration
PlaceboDrug
Lozenge matching V0498 lozenge, Oromucosal administration
| Study group | Role | What they receive |
|---|---|---|
| Drug | Experimental | V0498, Ibuprofen 25 mg Receives: Drug: Ibuprofen 25 mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-2 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Sore Throat PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785862
- Sponsor's protocol ID
- V00498 TA 3 01
- Other IDs
- 2012-004423-20
- Status last verified
- Jun 2013
- First submitted
- 5 Feb 2013
- Last updated
- 27 Jun 2013
- Results posted
- No
Publications
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.
PubMed 28869722
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Efficacy and Safety of V0498 Versus Placebo in Acute Sore Throat Pain.
- ClinicalTrials.gov ID
- NCT01785862
- Acronym / sponsor ID
- V00498 TA 3 01
- Conditions
- Acute Sore Throat Pain
- Keywords
- sore throat pain, tonsillopharyngitis, upper respiratory tract infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug | Experimental | Drug: Ibuprofen 25 mgV0498, Ibuprofen 25 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- male or female aged at least 18 years old
- patient with an acute sore throat
Key exclusion criteria (12 listed)
- Severe respiratory tract infection (pneumonia, bronchitis or laryngitis)
- Oro-pharyngeal paresthesia or mycosis
- Severely traumatised and/or very severe oromucosal inflammation
- Tonsillopharyngectomy
- Peritonsillar abscess
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen 25 mgLozenge, Oromucosal administration | Drug | Drug |
| PlaceboLozenge matching V0498 lozenge, Oromucosal administration | Drug | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
- Derived from this study: PubMed 28869722Bouroubi 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ibuprofen 25 mg in people with Acute Sore Throat Pain, run by Pierre Fabre Medicament at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Latvia, United Kingdom, France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Pain relief over 2 hours (time frame: 0-2 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01785862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2013.