E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10049140 |
E.1.2 | Term | Pharyngotonsillitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the analgesic effect of Ibuprofen lozenges (V0498TA01A
15mg, 25 mg, 35 mg) to placebo at 60 min after the start of sucking of
study drug administered in single dose. |
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E.2.2 | Secondary objectives of the trial |
- To compare the analgesic effect of Ibuprofen lozenges (V0498TA01A 15mg, 25 mg, 35mg) to placebo at 30 min, 90 min, 120 min, 180 min, 240 min, 300 min and 360 min after the start of sucking of study drug administered in single dose,
- To compare the pain relief of Ibuprofen lozenges (V0498TA01A 15mg; 25mg, 35mg) to placebo at 30 min, 60 min, 90 min, 120 min, 180 min, 240min, 300 min and 360 min after the start of sucking of study drug administered in single dose,
- To describe the analgesic effect and pain relief of the positive control:
Strefen® at 30 min, 60 min, 90 min, 120 min, 180 min, 240min, 300 min
and 360 min after the start of sucking of study drug administered in
single dose,
- To describe the safety of Ibuprofen lozenges
(V0498TA01A15mg,25mg,35mg), placebo and positive control. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female patients 18 years and older.
- patients with a sore throat associated or not with an URTI ≥ 24 hours and < or = 5 days duration, in the absence of Streptococcus group A. as confirmed by a swab test before randomisation
- patients with tonsillopharyngitis ≥ 6 on 21-point TPA (Tonsillo Pharyngitis Assessment) scale.
- patients with a Sore Throat Intensity Scale assessed by VAS more than
or equal to 60 mm.
- For female patients of child-bearing potential:
- Negative urinary pregnancy test.
- Use of an effective contraceptive method (oral contraception, surgical
method, intra-uterine device or diaphragm) during the study and at least
one week after the study end visit or
- Agreements to have her male partner(s) use a condom during each sexual intercourse during the study and at least one week after the study end visit.
- patients able to understand and to comply with all study procedures (e.g., such as those who could understand correctly the use of the pain rating scales).
- patients having signed a written informed consent.
- patients affiliated to a social security system or are beneficiaries. |
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E.4 | Principal exclusion criteria |
Related to pathologies
- patients with pharyngeal paresthesia.
- patients with pharyngeal mycosis.
- patients with known peritonsillar abscess.
- patients with hyposialia or asialia, any swallowing disorder.
- patients with any painful condition that may have distracted attention from sore throat pain, (e.g. mouth ulcers).
- patients with any disease that could compromise breathing such as bronchospasm or severe/instable asthma.
- patients with evidence of mouth-breathing or uncomfortable coughing.
- patients with a history of an upper gastrointestinal ulcer within the past 30 days, who are currently experiencing clinically significant upper gastrointestinal complaints, or are currently taking medication regularly (≥ 3 times in the previous week).
- patients with Crohn's disease or ulcerative colitis.
- patients with a severe renal impairment.
- patients with history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
- patients with gastrointestinal bleeding or cerebrovascular hemorrhage or other hemorrhage.
- patients with severe heart failure.
- patients with severe hepatic failure.
- patients with disseminated erythematous lupus.
- patients with glucose and galactose malabsorption syndrom,fructose intolerance, or sucrase-isomaltase deficiency.
Related to treatments
- patients with known history of Ibuprofen or other NSAID-induced bronchospasm.
- patients with a long term use of anti-inflammatory drugs.
- patients with a long term use of anticoagulants or antiplatelet agents.
- patients with hypersensitivity to Ibuprofen or other NSAIDs or the excipients.
- patients having used analgesics within 6 hours before study entry and who use analgesics more than ≥ 3 times per week.
- patients having used any long-acting or slow release analgesics within 12 hours before study entry (e.g. piroxicam or naproxen).
- patients having used any anti inflammatory treatment within 12 hours
before study entry.
- patients having used any antiseptics 6 hours before study entry.
- patients having used any local medication containing a local oral
anaesthetic such as lozenge, spray, mouth rinse within 6 hours before study entry.
- patients having used any topical throat treatment within 6 hours before study entry.
- patients having taken antibiotics within 14 days before study entry.
- patients having been treated with anticholinergic drugs, atropine,
scopolamine, quaternary ammoniums, imipraminic antidepressives,
phenothiazines neuroleptics, disopyramide, antimitotic drugs which influence salivary flow within 14 days before study entry.
- patients with history of disgust for mint, peppermint, menthol.
Related to population
- patients with a history of alcohol abuse.
- patients unable to refrain from smoking during their stay in the investigative site.
- patient who is a family member or work associate (secretary, nurse, technician ..) of the investigator
- Female patient who is in post-partum period or a nursing-mother
- patient who is participating in or is in the exclusion period of another
clinical trial
- patients mentally unable in the opinion of the investigator to
understand the nature and the objectives of the study and unable to
comply fully with the study requirements.
- patients who has forfeited their freedom by administrative or legal award, or who is under guardianship.
- patients who do not want to accept during the first 2H of the study, not to take other medications, suck other lozenges, use toothpaste, mouthwash, breath spray, smoke, use chew chewing gum, candies, eat or drink. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline of the Sore Throat Pain Intensity Scale (VAS) to 60 min |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Change from baseline of the sore throat pain intensity scale (VAS) to 30, 90, 120, 180, 240, 300 and 360 min.
- TOTPAR0-30 , TOTPAR0-60 , TOTPAR0-90 , TOTPAR0-120 , TOTPAR0- 180, , TOTPAR0-240 , TOTPAR0-300 and TOTPAR0-360 (calculated as Area Under the Curve (AUC) of the Total Pain Relief).
- SPID norm 0-30, SPID norm 0-60, SPID norm0-90, SPID norm0-120, SPID norm0-180, SPID norm0-240 SPID norm0-300 and SPID norm0- 360 (representing the time-weighted average relief over the selected
period). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
30 min, 60 min, 90 min, 120 min, 180 min, 240 min, 300 min, 360 min |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Strefen; positive control |
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E.8.2.4 | Number of treatment arms in the trial | 5 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study is the date of the phone call for the last patient undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |