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] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
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 evaluate the reduction* of inflammatory signs and symptoms (hyperemia, edema and pain) after 24 hours of treatment with ketoprofen when associated with amoxicillin.
* It is considered as a reduction of inflammatory signs and symptoms when there is an improvement in at least two of the three signs / symptoms evaluated: hyperemia, edema and pain.
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E.2.2 | Secondary objectives of the trial |
- To evaluate the reduction* of inflammatory signs and symptoms (hyperemia, edema and pain) after 72 hours of treatment with ketoprofen (active or placebo) when associated with amoxicillin.
- Usage of rescue medication (paracetamol) for fever or sore throat after randomization, during the period of ketoprofen treatment (active or placebo).
- Safety.
* It is considered as a reduction of inflammatory signs and symptoms when there is an improvement in at least two of the three signs / symptoms evaluated: hyperemia, edema and pain.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Indication for treatment with amoxicillin according to labeling and physician's clinical evaluation.
•Quick-test positive for Streptococcus pyogenes.
•Pain (swallowing), evaluated by Wong Baker Faces Pain scale with at least grade 3.
•Presence of at least two of the follow symptoms:
•Hyperemia and edema evaluated with at least 2 crosses from 4;
•Fever in the previous 48 hours;
•Cervical adenomegaly;
• Tonsilla with erythema or eythema and white exsudate
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E.4 | Principal exclusion criteria |
•History of cardiovascular, gastrointestinal, metabolic or psychiatric conditions.
•History and laboratorial confirmation of hematologic, hepatic or renal disorders.
•Use of NSAIDs during the last 3 weeks and gastroesophageal reflux during the last 6 months.
•Use of analgesic or anti inflammatory medication (except Paracetamol) in the previous 12 hours.
•History of allergy or hypersensitivity to amoxicillin and/ or ketoprofen
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment
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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) |
•Number of patients with reduction of inflammatory signs and symptoms after 72 hours of treatment
•Number of patients with reduction of inflammatory signs and symptoms with no use of rescue medication
•Number of patients who used rescue medication after randomization
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
•Number of patients with reduction of inflammatory signs and symptoms after 72 hours of treatment [ Time Frame: 72 hours ]
•Number of patients with reduction of inflammatory signs and symptoms with no use of rescue medication [ Time Frame: 24 hours and 72 hours ]
•Number of patients who used rescue medication after randomization. [ Time Frame: 72 hours ]
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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 | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 7 |