Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pharyngitis
Eligibility:
All Genders
2-8 years
Phase:
PHASE4
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 suspens...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT02229747
Start Date
August 1 2001
Last Update
September 1 2014
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