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

Pharyngitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02183038
• Other study ID #: 107.193
• Status: Completed
• Phase: Phase 2
• First received: July 4, 2014
• Last updated: July 7, 2014
• Start date: July 1998

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of HealthChile: Ministry of Health
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. primary completion date: February 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß-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 ß-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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharyngitis
• Tonsillitis

Intervention

Drug:
• Meloxicam low

• Meloxicam high

• Naproxen sodium

• Meloxicam placebo low

• Meloxicam placebo high

• Naproxen sodium placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intensity of spontaneous pharyngeal pain		Baseline, day 3 and 5	No
Primary	Change in intensity of pharyngeal pain on swallowing		Baseline, day 3 and 5	No
Secondary	Final global assessment of efficacy by patient		Day 5	No
Secondary	Final global assessment of efficacy by investigator		Day 5	No
Secondary	Final global assessment of tolerability by patient		Day 5	No
Secondary	Final global assessment of tolerability by investigator		Day 5	No
Secondary	Occurrence of disease systemic manifestations (fever, and general malaise)		up to 5 days	No
Secondary	Occurrence of pharyngeal hyperemia		up to 5 days	No
Secondary	Assessment of patient status		Day 5	No
Secondary	Occurrence of treatment withdrawal due to lack of efficacy		up to 5 days	No
Secondary	Occurrence of perforation, ulceration, bleeding (PUB) of the upper gastro-intestinal tract (stomach or duodenum)		up to day 5	Yes
Secondary	Intensity of adverse events		up to 19 days	No
Secondary	Number of patients who withdraw due to adverse event		up to 19 days	No
Secondary	Incidence of significant laboratory adverse events		up to 19 days	No
Secondary	Occurrence and duration of hospital stay due to Gastro-Intestinal Serious Adverse Events (GI-SAE)		up to 19 days	No
Secondary	Occurrence and duration of hospital stay due to adverse events related to trial drug administration		up to 19 days	No
Secondary	Occurrence of an additional visit at physician due to gastro-intestinal adverse event (GI-AE)		up to 19 days	No
Secondary	Number of patients with adverse events		up to 19 days	No
Secondary	Number of patients with adverse events related to trial drug		up to 19 days	No

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