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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02183038
Other study ID # 107.193
Secondary ID
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. completion date
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


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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