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

Pharyngitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229747
• Other study ID #: 107.250
• Status: Completed
• Phase: Phase 4
• First received: August 28, 2014
• Last updated: August 29, 2014
• Start date: August 2001

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. primary completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 8 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Laryngitis
• Pharyngitis

Intervention

Drug:
• Meloxicam

• Diclofenac

• Nimesulide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in spontaneous pharyngeal pain		baseline, 5 days	No
Primary	Change in pharyngeal pain on deglutition (dysphagia)		baseline, 5 days	No
Primary	Change in pharyngeal hyperemia		baseline, 5 days	No
Primary	Change in systemic manifestations (fever, adenomegaly and general malaise)		baseline, 5 days	No
Primary	Incidence of adverse events		baseline, 5 days	No

External Links

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