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

NCT02229747 | Completed Phase 4

• 1 other identifier: 107.250
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (5)

• Change in spontaneous pharyngeal pain

  baseline, 5 days

• Change in pharyngeal pain on deglutition (dysphagia)

  baseline, 5 days

• Change in pharyngeal hyperemia

  baseline, 5 days

• Change in systemic manifestations (fever, adenomegaly and general malaise)

  baseline, 5 days

• Incidence of adverse events

  baseline, 5 days

Study Arms (3)

Meloxicam suspension

EXPERIMENTAL

Drug: Meloxicam

Diclofenac suspension

ACTIVE COMPARATOR

Drug: Diclofenac

Nimesulide suspension

ACTIVE COMPARATOR

Drug: Nimesulide

Interventions

Meloxicam DRUG

Meloxicam suspension

Diclofenac DRUG

Diclofenac suspension

Nimesulide DRUG

Nimesulide suspension

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pharyngitis

Interventions

Meloxicam; Diclofenac; nimesulide

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 1, 2014
• Study Start: August 1, 2001
• Primary Completion: February 1, 2002
• Last Updated: September 1, 2014

Record last verified: 2014-07