NCT02183038

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 1999

Completed
15.4 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

7 months

First QC Date

July 4, 2014

Last Update Submit

July 7, 2014

Conditions

Pharyngitis

Outcome Measures

Primary Outcomes (2)

  • Change in intensity of spontaneous pharyngeal pain

    Baseline, day 3 and 5

  • Change in intensity of pharyngeal pain on swallowing

    Baseline, day 3 and 5

Secondary Outcomes (17)

  • Final global assessment of efficacy by patient

    Day 5

  • Final global assessment of efficacy by investigator

    Day 5

  • Final global assessment of tolerability by patient

    Day 5

  • Final global assessment of tolerability by investigator

    Day 5

  • Occurrence of disease systemic manifestations (fever, and general malaise)

    up to 5 days

  • +12 more secondary outcomes

Study Arms (3)

Meloxicam low & Placebo

EXPERIMENTAL
Drug: Meloxicam lowDrug: Meloxicam placebo highDrug: Naproxen sodium placebo

Meloxicam high & Placebo

EXPERIMENTAL
Drug: Meloxicam highDrug: Meloxicam placebo lowDrug: Naproxen sodium placebo

Naproxen sodium & Placebo

ACTIVE COMPARATOR
Drug: Naproxen sodiumDrug: Meloxicam placebo lowDrug: Meloxicam placebo high

Interventions

Meloxicam lowDRUG
Meloxicam low & Placebo
Meloxicam highDRUG
Meloxicam high & Placebo
Naproxen sodiumDRUG
Naproxen sodium & Placebo
Meloxicam placebo lowDRUG
Meloxicam high & PlaceboNaproxen sodium & Placebo
Meloxicam placebo highDRUG
Meloxicam low & PlaceboNaproxen sodium & Placebo
Naproxen sodium placeboDRUG
Meloxicam high & PlaceboMeloxicam low & Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pharyngitis

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2014

First Posted

July 8, 2014

Study Start

July 1, 1998

Primary Completion

February 1, 1999

Last Updated

July 8, 2014

Record last verified: 2014-07