Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02229747
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Pharyngitis Drug: Meloxicam Drug: Diclofenac Drug: Nimesulide Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2001
Actual Primary Completion Date : February 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
Experimental: Meloxicam suspension Drug: Meloxicam
Active Comparator: Diclofenac suspension Drug: Diclofenac
Active Comparator: Nimesulide suspension Drug: Nimesulide



Primary Outcome Measures :
  1. Change in spontaneous pharyngeal pain [ Time Frame: baseline, 5 days ]
  2. Change in pharyngeal pain on deglutition (dysphagia) [ Time Frame: baseline, 5 days ]
  3. Change in pharyngeal hyperemia [ Time Frame: baseline, 5 days ]
  4. Change in systemic manifestations (fever, adenomegaly and general malaise) [ Time Frame: baseline, 5 days ]
  5. Incidence of adverse events [ Time Frame: baseline, 5 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02229747     History of Changes
Other Study ID Numbers: 107.250
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Pharyngitis
Laryngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Laryngeal Diseases
Diclofenac
Meloxicam
Nimesulide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors