PharyngitisPhase 2NCT02183038
Efficacy and Safety of Meloxicam vs. Naproxen Sodium in Patients With Acute Non Bacterial Pharyngitis or Pharyngo-tonsillitis
A Phase 2 study testing Meloxicam low, Meloxicam high and Naproxen sodium in people with Pharyngitis, run by Boehringer Ingelheim.
Trial summary
Study to assess the efficacy and tolerability of Meloxicam once daily dose of 7.5 mg and 15 mg compared with 1100 mg of naproxen sodium in the symptomatic treatment of acute non bacterial pharyngitis or pharyngo-tonsillitis, over a period of 5 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharyngitis
- What is being tested?
- Meloxicam low, Meloxicam high and Naproxen sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- No sites listed yet
- Study dates
- Jul 1998to Feb 1999
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years or above
- Ambulatory patients
- Start of symptoms within the previous 24 hours
- Patients suffering from acute non bacterial pharyngitis or pharyngo-tonsillitis diagnostic, under the following criteria:
- spontaneous pharyngeal pain presence greater than 35 mm on a 100 mm visual analog scale (VAS)
- Pharyngeal pain presence on swallowing greater than 35 mm on a 100 mm VAS
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- Pharyngeal and/or amygdaline hyperemia
- Absence of purulent plaques
- Negative test for β-haemolytic Streptococcus on pharyngeal exudate
- Therapy with NSAID (Non-Steroid Anti-Inflammatory Drug) is required or recommended
- Patient's informed consent in accordance with local law and ICH GCP (International Conference of Harmonization Good Clinical Practice) , before inclusion into the the trial
Who cannot join
- Suspicion of acute pharyngitis or pharyngo-tonsillitis from bacterial origin by clinical criteria; Several impairment of patients condition, indicated by one or more or the following symptoms:
- Extremely rapid onset of clinical picture
- Very high fever (>38.5°C)
- Severe pharyngeal pain
- Cervical adenopathy
- Intense headache
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- Purulent pharyngeal plaques, evidence of peritonsillar abscess or phlegmon
- Known or suspected hypersensitivity to the trial drug or NSAIDs
- Positive test for β-haemolytic Streptococcus on pharyngeal exudate
- Therapy with antimicrobial agents prior to start of the trial
- Chronic infections
- Infectious mononucleosis
- Active peptic ulcer within the past 6 months
- Pregnancy or breast feeding precaution: attention should be drawn to reports that NSAIDs were reported to decrease the efficacy of intrauterine devices
- Asthma, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or NSAIDs
- Concomitant treatment with anti-coagulants (including heparin), lithium or methotrexate
- Concomitant administration of other NSAIDs (including high-dose > 1500 mg at day aspirin) or analgesic agents
- Administration of any NSAID during the last three days or analgesics 6 hours prior to the first administration of the trial drug
- Present treatment or treatment within the last two months with corticosteroids
- Historically know of impaired renal function (serum urea > 125 % of the upper limit of normal range; serum creatinine > 150 % of the upper limit of normal range)
- Historically know of severe liver injury (alanine amino transferase ALAT > 2 x the upper normal range limit or aspartate amino transferase ASAT > 2 x the upper normal range limit)
- Historically know of hematological disorder (platelet count < 100,000/mm3, leucocyte count < 3,000/mm3)
- Participation in another clinical trial during this study or during the previous month
- Previous participation in this trial
- Patient unable to comply with the protocol
About this study
Official title: Double-blind Study to Compare Efficacy and Safety of Meloxicam 7.5 mg and 15 mg vs. Naproxen Sodium 1100 mg in the Symptomatic Treatment of Acute Non Bacterial Pharyngitis or Pharyngo-tonsillitis Over a Period of 5 Days
Study to assess the efficacy and tolerability of Meloxicam once daily dose of 7.5 mg and 15 mg compared with 1100 mg of naproxen sodium in the symptomatic treatment of acute non bacterial pharyngitis or pharyngo-tonsillitis, over a period of 5 days.
- Conditions
- Pharyngitis
- Being tested
- Meloxicam low, Meloxicam high, Naproxen sodium, Meloxicam placebo low, Meloxicam placebo high
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meloxicam lowDrug
Meloxicam highDrug
Naproxen sodiumDrug
Meloxicam placebo lowDrug
Meloxicam placebo highDrug
Naproxen sodium placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Meloxicam low & Placebo | Experimental | Not described Receives: Drug: Meloxicam low; Drug: Meloxicam placebo high; Drug: Naproxen sodium placebo |
| Meloxicam high & Placebo | Experimental | Not described Receives: Drug: Meloxicam high; Drug: Meloxicam placebo low; Drug: Naproxen sodium placebo |
| Naproxen sodium & Placebo | Active comparator | Not described Receives: Drug: Naproxen sodium; Drug: Meloxicam placebo low; Drug: Meloxicam placebo high |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intensity of spontaneous pharyngeal pain
Measured: Baseline, day 3 and 5
Change in intensity of pharyngeal pain on swallowing
Measured: Baseline, day 3 and 5
Secondary outcomes (17)
Final global assessment of efficacy by patient
Measured: Day 5
Final global assessment of efficacy by investigator
Measured: Day 5
Final global assessment of tolerability by patient
Measured: Day 5
Final global assessment of tolerability by investigator
Measured: Day 5
Occurrence of disease systemic manifestations (fever, and general malaise)
Measured: up to 5 days
Occurrence of pharyngeal hyperemia
Measured: up to 5 days
Assessment of patient status
Measured: Day 5
Occurrence of treatment withdrawal due to lack of efficacy
Measured: up to 5 days
Occurrence of perforation, ulceration, bleeding (PUB) of the upper gastro-intestinal tract (stomach or duodenum)
Measured: up to day 5
Intensity of adverse events
Measured: up to 19 days
Number of patients who withdraw due to adverse event
Measured: up to 19 days
Incidence of significant laboratory adverse events
Measured: up to 19 days
Occurrence and duration of hospital stay due to Gastro-Intestinal Serious Adverse Events (GI-SAE)
Measured: up to 19 days
Occurrence and duration of hospital stay due to adverse events related to trial drug administration
Measured: up to 19 days
Occurrence of an additional visit at physician due to gastro-intestinal adverse event (GI-AE)
Measured: up to 19 days
Number of patients with adverse events
Measured: up to 19 days
Number of patients with adverse events related to trial drug
Measured: up to 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJul 1998
- Primary completionFeb 1999
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 390 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
- NCT02183038
- Sponsor's protocol ID
- 107.193
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Study to Compare Efficacy and Safety of Meloxicam 7.5 mg and 15 mg vs. Naproxen Sodium 1100 mg in the Symptomatic Treatment of Acute Non Bacterial Pharyngitis or Pharyngo-tonsillitis Over a Period of 5 Days
- ClinicalTrials.gov ID
- NCT02183038
- Acronym / sponsor ID
- 107.193
- Conditions
- Pharyngitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 1998
- Primary completion
- Feb 1999 (actual)
- First posted
- 8 Jul 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.
Study to assess the efficacy and tolerability of Meloxicam once daily dose of 7.5 mg and 15 mg compared with 1100 mg of naproxen sodium in the symptomatic treatment of acute non bacterial pharyngitis or pharyngo-tonsillitis, over a period of 5 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meloxicam low & Placebo | Experimental | Drug: Meloxicam low, Drug: Meloxicam placebo high, Drug: Naproxen sodium placebo |
| Meloxicam high & Placebo | Experimental | Drug: Meloxicam high, Drug: Meloxicam placebo low, Drug: Naproxen sodium placebo |
| Naproxen sodium & Placebo | Active comparator | Drug: Naproxen sodium, Drug: Meloxicam placebo low, Drug: Meloxicam placebo high |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female aged 18 years or above
- Ambulatory patients
- Start of symptoms within the previous 24 hours
- Patients suffering from acute non bacterial pharyngitis or pharyngo-tonsillitis diagnostic, under the following criteria:
- Therapy with NSAID (Non-Steroid Anti-Inflammatory Drug) is required or recommended
Key exclusion criteria (25 listed)
- Suspicion of acute pharyngitis or pharyngo-tonsillitis from bacterial origin by clinical criteria; Several impairment of patients condition, indicated by one or more or the following symptoms:
- Known or suspected hypersensitivity to the trial drug or NSAIDs
- Positive test for β-haemolytic Streptococcus on pharyngeal exudate
- Therapy with antimicrobial agents prior to start of the trial
- Chronic infections
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 low | Drug | Meloxicam low & Placebo |
| Meloxicam high | Drug | Meloxicam high & Placebo |
| Naproxen sodium | Drug | Naproxen sodium & Placebo |
| Meloxicam placebo low | Drug | Meloxicam high & Placebo, Naproxen sodium & Placebo |
| Meloxicam placebo high | Drug | Meloxicam low & Placebo, Naproxen sodium & Placebo |
| Naproxen sodium placebo | Drug | Meloxicam high & Placebo, Meloxicam low & Placebo |
Primary outcome
Change in intensity of spontaneous pharyngeal pain
Time frame: Baseline, day 3 and 5
Change in intensity of pharyngeal pain on swallowing
Time frame: Baseline, day 3 and 5
17 secondary outcomes
Final global assessment of efficacy by patient
Time frame: Day 5
Final global assessment of efficacy by investigator
Time frame: Day 5
Final global assessment of tolerability by patient
Time frame: Day 5
Final global assessment of tolerability by investigator
Time frame: Day 5
Occurrence of disease systemic manifestations (fever, and general malaise)
Time frame: up to 5 days
Occurrence of pharyngeal hyperemia
Time frame: up to 5 days
Assessment of patient status
Time frame: Day 5
Occurrence of treatment withdrawal due to lack of efficacy
Time frame: up to 5 days
Occurrence of perforation, ulceration, bleeding (PUB) of the upper gastro-intestinal tract (stomach or duodenum)
Time frame: up to day 5
Intensity of adverse events
Time frame: up to 19 days
Number of patients who withdraw due to adverse event
Time frame: up to 19 days
Incidence of significant laboratory adverse events
Time frame: up to 19 days
Occurrence and duration of hospital stay due to Gastro-Intestinal Serious Adverse Events (GI-SAE)
Time frame: up to 19 days
Occurrence and duration of hospital stay due to adverse events related to trial drug administration
Time frame: up to 19 days
Occurrence of an additional visit at physician due to gastro-intestinal adverse event (GI-AE)
Time frame: up to 19 days
Number of patients with adverse events
Time frame: up to 19 days
Number of patients with adverse events related to trial drug
Time frame: up to 19 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 8 Jul 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 2 study testing Meloxicam low, Meloxicam high and Naproxen sodium 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 11 inclusion and 25 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 8 Jul 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 intensity of spontaneous pharyngeal pain (time frame: Baseline, day 3 and 5). The study lists 2 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 8 Jul 2014.