Back to resultsEfficacy and Safety of Meloxicam Suspension Versus Diclofenac Suspension or Nimesulide Suspension in Patients With a Diagnosis of Acute, Non-bacterial Pharyngitis, Pharyngotonsillitis or Laryngitis
Primary Purpose
Pharyngitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Meloxicam
Diclofenac
Nimesulide
Sponsored by
About this trial
This is an interventional treatment trial for Pharyngitis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Meloxicam suspension
Diclofenac suspension
Nimesulide suspension
Arm Description
Outcomes
Primary Outcome Measures
Change in spontaneous pharyngeal pain
Change in pharyngeal pain on deglutition (dysphagia)
Change in pharyngeal hyperemia
Change in systemic manifestations (fever, adenomegaly and general malaise)
Incidence of adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02229747
Brief Title
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
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meloxicam suspension
Arm Type
Experimental
Arm Title
Diclofenac suspension
Arm Type
Active Comparator
Arm Title
Nimesulide suspension
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Meloxicam
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Intervention Type
Drug
Intervention Name(s)
Nimesulide
Primary Outcome Measure Information:
Title
Change in spontaneous pharyngeal pain
Time Frame
baseline, 5 days
Title
Change in pharyngeal pain on deglutition (dysphagia)
Time Frame
baseline, 5 days
Title
Change in pharyngeal hyperemia
Time Frame
baseline, 5 days
Title
Change in systemic manifestations (fever, adenomegaly and general malaise)
Time Frame
baseline, 5 days
Title
Incidence of adverse events
Time Frame
baseline, 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.250_U11-3428-01.pdf
Description
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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
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