Acute Sore Throat PainPhase 2NCT01535079
Acute Sore Throat Pain Study
A Phase 2 study testing Ibuprofen 35 mg, Ibuprofen 25 mg and Ibuprofen 15 mg in people with Acute Sore Throat Pain, run by Pierre Fabre Medicament at 4 sites in 3 countries.
Trial summary
"Sore throat is one of the most common complaints encountered in clinical practice. And in 65% of cases, the infection is thought to be viral in nature. The aim of this study is to evaluate the analgesic profile of 3 Ibuprofen lozenges after single administration in 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 35 mg, Ibuprofen 25 mg and Ibuprofen 15 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Feb 2012to Nov 2012
- Phase
- Phase 2
- 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 patients 18 years and older
- patients with a sore throat associated or not with an Upper Respiratory Tract Infection ≥ 24 hours and ≤ 5 days duration, in the absence of Streptococcus group A
Who cannot join
- patients with hypersensitivity to Ibuprofen or other NSAIDs or the excipients.
- patients having used analgesics or antiseptics or any topical throat treatment or any local medication containing a local oral anaesthetic within 6 hours before study entry and who use analgesics more than ≥ 3 times per week.
- patients having used any anti inflammatory treatment or any long-acting or slow release analgesics within 12 hours before study entry
- patients having taken antibiotics within 14 days before study entry.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
About this study
Official title: Analgesic Profile of 3 New Ibuprofen Lozenges (V0498TA01A 15 mg, 25 mg, 35 mg) After Single Administration in Acute Sore Throat Pain
"Sore throat is one of the most common complaints encountered in clinical practice. And in 65% of cases, the infection is thought to be viral in nature.
The aim of this study is to evaluate the analgesic profile of 3 Ibuprofen lozenges after single administration in acute sore throat pain."
- Conditions
- Acute Sore Throat Pain
- Being tested
- Placebo, Ibuprofen 35 mg, Ibuprofen 25 mg, Ibuprofen 15 mg, Strefen
- 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.
PlaceboDrug
Single administration
Ibuprofen 35 mgDrug
Single administration
Ibuprofen 25 mgDrug
Single administration
Ibuprofen 15 mgDrug
Single administration
StrefenDrug
Single administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| V0498TA01A 15 mg | Experimental | Not described Receives: Drug: Ibuprofen 15 mg |
| V0498TA01A 25 mg | Experimental | Not described Receives: Drug: Ibuprofen 25 mg |
| V0498TA01A 35 mg | Experimental | Not described Receives: Drug: Ibuprofen 35 mg |
| Strefen | Other | Positive control Receives: Drug: Strefen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of Sore Throat Pain Intensity Scale
Measured: 60 minutes
Secondary outcomes (4)
Change from baseline of Sore Throat Pain relief Scale
Measured: up to 360 minutes
Change of Sore Throat Pain Intensity Scales
Measured: up to 360 minutes
Local tolerability examination
Mouth examination including extent of erythema, edema, petechial hemorrhages, ulceration (4 point scale : none, mild, moderate and severe).
Measured: Baseline (before drug intake) and 360 minutes
General tolerability (reported adverse events)
Measured: Baseline (before drug intake) and 360 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 186 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
- NCT01535079
- Sponsor's protocol ID
- V00498 TA 2 01
- Other IDs
- 2011-005848-10
- Status last verified
- Oct 2012
- First submitted
- 10 Feb 2012
- Last updated
- 12 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Profile of 3 New Ibuprofen Lozenges (V0498TA01A 15 mg, 25 mg, 35 mg) After Single Administration in Acute Sore Throat Pain
- ClinicalTrials.gov ID
- NCT01535079
- Acronym / sponsor ID
- V00498 TA 2 01
- Conditions
- Acute Sore Throat Pain
- Keywords
- sore throat pain, tonsillopharyngitis, upper respiratory tract infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 17 Feb 2012 (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.
"Sore throat is one of the most common complaints encountered in clinical practice. And in 65% of cases, the infection is thought to be viral in nature.
The aim of this study is to evaluate the analgesic profile of 3 Ibuprofen lozenges after single administration in acute sore throat pain."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| V0498TA01A 15 mg | Experimental | Drug: Ibuprofen 15 mg |
| V0498TA01A 25 mg | Experimental | Drug: Ibuprofen 25 mg |
| V0498TA01A 35 mg | Experimental | Drug: Ibuprofen 35 mg |
| Strefen | Other | Drug: StrefenPositive control |
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 patients 18 years and older
- patients with a sore throat associated or not with an Upper Respiratory Tract Infection ≥ 24 hours and ≤ 5 days duration, in the absence of Streptococcus group A
Key exclusion criteria (4 listed)
- patients with hypersensitivity to Ibuprofen or other NSAIDs or the excipients.
- patients having used analgesics or antiseptics or any topical throat treatment or any local medication containing a local oral anaesthetic within 6 hours before study entry and who use analgesics more than ≥ 3 times per week.
- patients having used any anti inflammatory treatment or any long-acting or slow release analgesics within 12 hours before study entry
- patients having taken antibiotics within 14 days before study entry.
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 |
|---|---|---|
| PlaceboSingle administration | Drug | Placebo |
| Ibuprofen 35 mgSingle administration | Drug | V0498TA01A 35 mg |
| Ibuprofen 25 mgSingle administration | Drug | V0498TA01A 25 mg |
| Ibuprofen 15 mgSingle administration | Drug | V0498TA01A 15 mg |
| StrefenSingle administration | Drug | Strefen |
Primary outcome
Change from baseline of Sore Throat Pain Intensity Scale
Time frame: 60 minutes
4 secondary outcomes
Change from baseline of Sore Throat Pain relief Scale
Time frame: up to 360 minutes
Change of Sore Throat Pain Intensity Scales
Time frame: up to 360 minutes
Local tolerability examination
Time frame: Baseline (before drug intake) and 360 minutes
General tolerability (reported adverse events)
Time frame: Baseline (before drug intake) and 360 minutes
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 12 Nov 2012.
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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibuprofen 35 mg, Ibuprofen 25 mg and Ibuprofen 15 mg in people with Acute Sore Throat Pain, run by Pierre Fabre Medicament at 4 sites in 3 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 4 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 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline of Sore Throat Pain Intensity Scale (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2012; AzTrials last refreshed its copy on 27 Oct 2026.