PharyngitisPhase 4NCT02229747
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 study testing Meloxicam, Diclofenac and Nimesulide in people with Pharyngitis, run by Boehringer Ingelheim.
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… Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Pharyngitis
- What is being tested?
- Meloxicam, Diclofenac and Nimesulide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Aug 2001to Feb 2002
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
About this study
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
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
- Being tested
- Meloxicam, Diclofenac, Nimesulide
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeloxicamDrug
DiclofenacDrug
NimesulideDrug
| Study group | Role | What they receive |
|---|---|---|
| Meloxicam suspension | Experimental | Not described Receives: Drug: Meloxicam |
| Diclofenac suspension | Active comparator | Not described Receives: Drug: Diclofenac |
| Nimesulide suspension | Active comparator | Not described Receives: Drug: Nimesulide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spontaneous pharyngeal pain
Measured: baseline, 5 days
Change in pharyngeal pain on deglutition (dysphagia)
Measured: baseline, 5 days
Change in pharyngeal hyperemia
Measured: baseline, 5 days
Change in systemic manifestations (fever, adenomegaly and general malaise)
Measured: baseline, 5 days
Incidence of adverse events
Measured: baseline, 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startAug 2001
- Primary completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharyngitisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229747
- Sponsor's protocol ID
- 107.250
- Status last verified
- Jul 2014
- First submitted
- 28 Aug 2014
- Last updated
- 1 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02229747
- Acronym / sponsor ID
- 107.250
- Conditions
- Pharyngitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- Feb 2002 (actual)
- First posted
- 1 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meloxicam suspension | Experimental | Drug: Meloxicam |
| Diclofenac suspension | Active comparator | Drug: Diclofenac |
| Nimesulide suspension | Active comparator | Drug: Nimesulide |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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:
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meloxicam | Drug | Meloxicam suspension |
| Diclofenac | Drug | Diclofenac suspension |
| Nimesulide | Drug | Nimesulide suspension |
Primary outcome
Change in spontaneous pharyngeal pain
Time frame: baseline, 5 days
Change in pharyngeal pain on deglutition (dysphagia)
Time frame: baseline, 5 days
Change in pharyngeal hyperemia
Time frame: baseline, 5 days
Change in systemic manifestations (fever, adenomegaly and general malaise)
Time frame: baseline, 5 days
Incidence of adverse events
Time frame: baseline, 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Meloxicam, Diclofenac and Nimesulide in people with Pharyngitis, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in spontaneous pharyngeal pain (time frame: baseline, 5 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2014.