Efficacy and Safety of Meloxicam Suspension Versus Diclofenac Suspension or Nimesulide Suspension in Patients With a Diagnosis of Acute, Non-bacterial Pharyngitis, Pharyngotonsillitis or Laryngitis

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

Pharyngitis

Treatments

Drug: Meloxicam

Drug: Diclofenac

Drug: Nimesulide

Study type

Interventional

Funder types

Industry

Identifiers

NCT02229747

107.250

Details and patient eligibility

About

The objective of this study was to assess the clinical efficacy and safety of meloxicam suspension 0.25 mg/kg/day once a day, versus diclofenac suspension 1 mg/kg/day twice a day or nimesulide suspension 4 mg/kg/day twice a day, after five days of treatment in patients with a diagnosis of acute, non-bacterial pharyngitis, pharyngotonsillitis or laryngitis

Enrollment

128 patients

Sex

All

Ages

2 to 8 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients of both genders between 2 and 8 years old
Outpatients, with onset of symptoms not more than 72 hours prior to presentation, patients with acute non-bacterial pharyngitis or pharyngotonsillitis diagnosed according to the following criteria:
- Spontaneous pharyngeal pain, pharyngeal pain upon swallowing, pharyngeal and/or tonsillar hyperemia, absence of purulent plaques, pharyngeal smear negative for ß-hemolytic Streptococcus or Strepto Test® and Treatment with an Non-steroidal anti-inflammatory drugs (NSAID) required or recommended

Exclusion criteria

Known or suspected hypersensitivity to study medications or NSAID's
Pharyngeal smear positive for ß-hemolytic Streptococcus
treatment with antimicrobials prior to enrolment in the study
Chronic infection, infectious mononucleosis, peptic ulcer disease that has been active in the previous 6 months
Asthma
nasal polyps
angioneurotic edema or urticaria after the administration of aspirin or NSAID's
Concomitant treatment with anticoagulants (including heparin), lithium or methotrexate
Concomitant administration of other NSAID's (including high dose aspirin) or analgesics, except authorized rescue drugs
Administration of any NSAID during the three previous days or of analgesics within six hours prior to the administration of the first study drug dose
Treatment with corticosteroids at the time of enrollment or within the two previous months
Known liver, renal or hematological disease
Participation in another clinical trial during the study period or during the previous month
Previous enrollment in this study
Inability to comply with the protocol
Suspected acute bacterial pharyngitis or pharyngotonsillitis (under the following clinical criteria):
- Clinical presentation characterized by a rapid onset, very high fever (>38.5°C), severe pharyngeal pain, cervical adenopathy, intense headache, purulent pharyngeal plaques, evidence of peritonsillar abscess or phlegmon