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CompletedNCT02229747Updated Sep 1, 2014

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

A Phase 4 interventional study of Meloxicam and Diclofenac in Pharyngitis, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 2 Years to 8 Years. Per ClinicalTrials.gov, last updated 2014-09-01.

Sponsored by Boehringer Ingelheim · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
2 Years to 8 Years
Sex
All
01

Study 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

02

Conditions studied

  • Pharyngitis

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03

In context

Pharyngitis

226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.

This study's enrollment of 128 is below the median of 144 across 188 interventional studies indexed under Pharyngitis.

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Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 62 are open to participants now.

Of its 167 completed or terminated interventional studies of FDA-regulated products, 123 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Known or suspected 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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
128 participants (actual)

Study arms

  • Experimental
    Meloxicam suspension

    Drug: Meloxicam

  • Active comparator
    Diclofenac suspension

    Drug: Diclofenac

  • Active comparator
    Nimesulide suspension

    Drug: Nimesulide

Interventions

06

What researchers measure

Primary outcomes

  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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02229747
Responsible party
Sponsor
First posted
Sep 1, 2014
Start date
Aug 2001
Primary completion
Feb 2002
Last update
Sep 1, 2014
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Meloxicam

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