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Efficacy and Safety of Meloxicam vs. Naproxen Sodium in Patients With Acute Non Bacterial Pharyngitis or Pharyngo-tonsillitis

Primary Purpose

Pharyngitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Meloxicam low
Meloxicam high
Naproxen sodium
Meloxicam placebo low
Meloxicam placebo high
Naproxen sodium placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pharyngitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Meloxicam low & Placebo

    Meloxicam high & Placebo

    Naproxen sodium & Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in intensity of spontaneous pharyngeal pain
    Change in intensity of pharyngeal pain on swallowing

    Secondary Outcome Measures

    Final global assessment of efficacy by patient
    Final global assessment of efficacy by investigator
    Final global assessment of tolerability by patient
    Final global assessment of tolerability by investigator
    Occurrence of disease systemic manifestations (fever, and general malaise)
    Occurrence of pharyngeal hyperemia
    Assessment of patient status
    Occurrence of treatment withdrawal due to lack of efficacy
    Occurrence of perforation, ulceration, bleeding (PUB) of the upper gastro-intestinal tract (stomach or duodenum)
    Intensity of adverse events
    Number of patients who withdraw due to adverse event
    Incidence of significant laboratory adverse events
    Occurrence and duration of hospital stay due to Gastro-Intestinal Serious Adverse Events (GI-SAE)
    Occurrence and duration of hospital stay due to adverse events related to trial drug administration
    Occurrence of an additional visit at physician due to gastro-intestinal adverse event (GI-AE)
    Number of patients with adverse events
    Number of patients with adverse events related to trial drug

    Full Information

    First Posted
    July 4, 2014
    Last Updated
    July 7, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02183038
    Brief Title
    Efficacy and Safety of Meloxicam vs. Naproxen Sodium in Patients With Acute Non Bacterial Pharyngitis or Pharyngo-tonsillitis
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1998 (undefined)
    Primary Completion Date
    February 1999 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pharyngitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    390 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Meloxicam low & Placebo
    Arm Type
    Experimental
    Arm Title
    Meloxicam high & Placebo
    Arm Type
    Experimental
    Arm Title
    Naproxen sodium & Placebo
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Meloxicam low
    Intervention Type
    Drug
    Intervention Name(s)
    Meloxicam high
    Intervention Type
    Drug
    Intervention Name(s)
    Naproxen sodium
    Intervention Type
    Drug
    Intervention Name(s)
    Meloxicam placebo low
    Intervention Type
    Drug
    Intervention Name(s)
    Meloxicam placebo high
    Intervention Type
    Drug
    Intervention Name(s)
    Naproxen sodium placebo
    Primary Outcome Measure Information:
    Title
    Change in intensity of spontaneous pharyngeal pain
    Time Frame
    Baseline, day 3 and 5
    Title
    Change in intensity of pharyngeal pain on swallowing
    Time Frame
    Baseline, day 3 and 5
    Secondary Outcome Measure Information:
    Title
    Final global assessment of efficacy by patient
    Time Frame
    Day 5
    Title
    Final global assessment of efficacy by investigator
    Time Frame
    Day 5
    Title
    Final global assessment of tolerability by patient
    Time Frame
    Day 5
    Title
    Final global assessment of tolerability by investigator
    Time Frame
    Day 5
    Title
    Occurrence of disease systemic manifestations (fever, and general malaise)
    Time Frame
    up to 5 days
    Title
    Occurrence of pharyngeal hyperemia
    Time Frame
    up to 5 days
    Title
    Assessment of patient status
    Time Frame
    Day 5
    Title
    Occurrence of treatment withdrawal due to lack of efficacy
    Time Frame
    up to 5 days
    Title
    Occurrence of perforation, ulceration, bleeding (PUB) of the upper gastro-intestinal tract (stomach or duodenum)
    Time Frame
    up to day 5
    Title
    Intensity of adverse events
    Time Frame
    up to 19 days
    Title
    Number of patients who withdraw due to adverse event
    Time Frame
    up to 19 days
    Title
    Incidence of significant laboratory adverse events
    Time Frame
    up to 19 days
    Title
    Occurrence and duration of hospital stay due to Gastro-Intestinal Serious Adverse Events (GI-SAE)
    Time Frame
    up to 19 days
    Title
    Occurrence and duration of hospital stay due to adverse events related to trial drug administration
    Time Frame
    up to 19 days
    Title
    Occurrence of an additional visit at physician due to gastro-intestinal adverse event (GI-AE)
    Time Frame
    up to 19 days
    Title
    Number of patients with adverse events
    Time Frame
    up to 19 days
    Title
    Number of patients with adverse events related to trial drug
    Time Frame
    up to 19 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.193_U01-3344.pdf
    Description
    Related Info

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    Efficacy and Safety of Meloxicam vs. Naproxen Sodium in Patients With Acute Non Bacterial Pharyngitis or Pharyngo-tonsillitis

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