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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharyngitis

Intervention: Meloxicam low (Drug); Meloxicam high (Drug); Naproxen sodium (Drug); Meloxicam placebo low (Drug); Meloxicam placebo high (Drug); Naproxen sodium placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Boehringer Ingelheim

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.

Clinical Details

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

Primary outcome:

Change in intensity of spontaneous pharyngeal pain

Change in intensity of pharyngeal pain on swallowing

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: July 1998
Last updated: July 7, 2014

Page last updated: August 23, 2015

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