Efficacy and Safety of Meloxicam vs. Naproxen Sodium in Patients With Acute Non Bacterial Pharyng… (NCT02183038) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Meloxicam vs. Naproxen Sodium in Patients With Acute Non Bacterial Pharyngitis or Pharyngo-tonsillitis
390 participantsStarted 1998-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* spontaneous pharyngeal pain presence greater than 35 mm on a 100 mm visual analog scale (VAS)
* Pharyngeal pain presence on swallowing greater than 35 mm on a 100 mm VAS
* Pharyngeal and/or amygdaline hyperemia
* Absence of purulent plaques
* Negative test for β-haemolytic Streptococcus on pharyngeal exudate
* 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:
* Extremely rapid onset of clinical picture
* Very high fever (\>38.5°C)
* Severe pharyngeal pain
* Cervical adenopathy
* Intense headache
* Purulent pharyngeal plaques, evidence of peritonsillar abscess or phlegmon
* 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 infect…
What they're measuring
1
Change in intensity of spontaneous pharyngeal pain
Timeframe: Baseline, day 3 and 5
2
Change in intensity of pharyngeal pain on swallowing