Clinical trial NCT02229747: 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
Official title: Randomized, Open-label, Controlled Trial to Assess the Clinical Efficacy and Safety of Meloxicam Suspension 0.25 mg/kg/Day Once a Day, Versus Diclofenac 1 mg/kg/Day Twice a Day or Nimesulide 4 mg/kg/Day Twice a Day, for Five Days in the Treatment of Patients With Acute, Non-bacterial Pharyngitis, Pharyngotonsillitis or Laryngitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pharyngitis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-01
Enrollment: 128
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Change in spontaneous pharyngeal pain
timeFrame: baseline, 5 days
measure: Change in pharyngeal pain on deglutition (dysphagia)
timeFrame: baseline, 5 days
measure: Change in pharyngeal hyperemia
timeFrame: baseline, 5 days
measure: Change in systemic manifestations (fever, adenomegaly and general malaise)
timeFrame: baseline, 5 days
measure: Incidence of adverse events
timeFrame: baseline, 5 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: