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Study to assess the efficacy and tolerability of Meloxicam once daily dose of 7.5 mg and 15 mg compared with 1100 mg of naproxen sodium in the symptomatic treatment of acute non bacterial pharyngitis or pharyngo-tonsillitis, over a period of 5 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam low & Placebo | Experimental |
| |
| Meloxicam high & Placebo | Experimental |
| |
| Naproxen sodium & Placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam low | Drug |
| ||
| Meloxicam high |
| Measure | Description | Time Frame |
|---|---|---|
| Change in intensity of spontaneous pharyngeal pain | Baseline, day 3 and 5 | |
| Change in intensity of pharyngeal pain on swallowing | Baseline, day 3 and 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Final global assessment of efficacy by patient | Day 5 | |
| Final global assessment of efficacy by investigator | Day 5 | |
| Final global assessment of tolerability by patient |
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Inclusion Criteria:
Male or female aged 18 years or above
Ambulatory patients
Start of symptoms within the previous 24 hours
Patients suffering from acute non bacterial pharyngitis or pharyngo-tonsillitis diagnostic, under the following criteria:
Therapy with NSAID (Non-Steroid Anti-Inflammatory Drug) is required or recommended
Patient's informed consent in accordance with local law and ICH GCP (International Conference of Harmonization Good Clinical Practice) , before inclusion into the the trial
Exclusion Criteria:
Suspicion of acute pharyngitis or pharyngo-tonsillitis from bacterial origin by clinical criteria; Several impairment of patients condition, indicated by one or more or the following symptoms:
Known or suspected hypersensitivity to the trial drug or NSAIDs
Positive test for β-haemolytic Streptococcus on pharyngeal exudate
Therapy with antimicrobial agents prior to start of the trial
Chronic infections
Infectious mononucleosis
Active peptic ulcer within the past 6 months
Pregnancy or breast feeding precaution: attention should be drawn to reports that NSAIDs were reported to decrease the efficacy of intrauterine devices
Asthma, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or NSAIDs
Concomitant treatment with anti-coagulants (including heparin), lithium or methotrexate
Concomitant administration of other NSAIDs (including high-dose > 1500 mg at day aspirin) or analgesic agents
Administration of any NSAID during the last three days or analgesics 6 hours prior to the first administration of the trial drug
Present treatment or treatment within the last two months with corticosteroids
Historically know of impaired renal function (serum urea > 125 % of the upper limit of normal range; serum creatinine > 150 % of the upper limit of normal range)
Historically know of severe liver injury (alanine amino transferase ALAT > 2 x the upper normal range limit or aspartate amino transferase ASAT > 2 x the upper normal range limit)
Historically know of hematological disorder (platelet count < 100,000/mm3, leucocyte count < 3,000/mm3)
Participation in another clinical trial during this study or during the previous month
Previous participation in this trial
Patient unable to comply with the protocol
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|
| Naproxen sodium | Drug |
|
| Meloxicam placebo low | Drug |
|
| Meloxicam placebo high | Drug |
|
| Naproxen sodium placebo | Drug |
|
| Day 5 |
| Final global assessment of tolerability by investigator | Day 5 |
| Occurrence of disease systemic manifestations (fever, and general malaise) | up to 5 days |
| Occurrence of pharyngeal hyperemia | up to 5 days |
| Assessment of patient status | Day 5 |
| Occurrence of treatment withdrawal due to lack of efficacy | up to 5 days |
| Occurrence of perforation, ulceration, bleeding (PUB) of the upper gastro-intestinal tract (stomach or duodenum) | up to day 5 |
| Intensity of adverse events | up to 19 days |
| Number of patients who withdraw due to adverse event | up to 19 days |
| Incidence of significant laboratory adverse events | up to 19 days |
| Occurrence and duration of hospital stay due to Gastro-Intestinal Serious Adverse Events (GI-SAE) | up to 19 days |
| Occurrence and duration of hospital stay due to adverse events related to trial drug administration | up to 19 days |
| Occurrence of an additional visit at physician due to gastro-intestinal adverse event (GI-AE) | up to 19 days |
| Number of patients with adverse events | up to 19 days |
| Number of patients with adverse events related to trial drug | up to 19 days |
| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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