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

NCT ID: NCT02229747

Last Updated: 2014-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31

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

Conditions

Pharyngitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Meloxicam suspension

Group Type: EXPERIMENTAL

Meloxicam

Intervention Type: DRUG

Diclofenac suspension

Group Type: ACTIVE_COMPARATOR

Diclofenac

Intervention Type: DRUG

Nimesulide suspension

Group Type: ACTIVE_COMPARATOR

Nimesulide

Intervention Type: DRUG

Interventions

Meloxicam

Intervention Type: DRUG

Diclofenac

Intervention Type: DRUG

Nimesulide

Intervention Type: DRUG

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

107.250

Identifier Type: -

Identifier Source: org_study_id