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DOUBLE-BLIND, DOUBLE-CONTROLED STUDY TO COMPARE THE EFFICACY AND SAFETY OF MELOXICAM (NIFLAMIN) 15MG, AGAINST PLACEBO IN THE SYMPTOMATIC TREATMENT OF PHARMINGITIS OR FARINGO-NON-BACTERIAL ACUTE AMIGADALITIS IN A PERIOD OF 5 DAYS.

DOUBLE-BLIND, DOUBLE-CONTROLED STUDY TO COMPARE THE EFFICACY AND SAFETY OF MELOXICAM (NIFLAMIN) 15MG, AGAINST PLACEBO IN THE SYMPTOMATIC TREATMENT OF PHARMINGITIS OR FARINGO-NON-BACTERIAL ACUTE AMIGADALITIS IN A PERIOD OF 5 DAYS.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-053-02
Enrollment
6
Registered
2002-08-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Meloxicam 15 mg Type of group
Patients will be administered meloxicam 15 mg once a day for a period of 5 days. Group name:placebo Type of group
Patients will be given placebo of meloxicam 15 mg once a day for a period of 5 days.

Sponsors

QUIMICA SUIZA S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Man or woman 18 years of age or older. • Outpatient. • Symptoms start within 24 hours. • Patients suffering from diagnosis of pharyngitis or acute pharyngitis-tonsillitis not bacterial

Exclusion criteria

Exclusion criteria: • Suspected pharyngitis or acute pharyngitis-tonsillitis of bacterial origin by clinical criteria • Known or suspected hypersensitivity to the study drug or to NSAIDs. • Examination for 13-hemolytic streptococcus in positive pharyngeal exudate. • Therapy with antimicrobial agents prior to the start of the study. • Chronic infections. • Infectious mononucleosis. • Active peptic ulcer within the previous 6 months. • Pregnancy or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Outcome name:Spontaneous pharyngeal pain. Pharyngeal pain when swallowing. Measure:evaluate the efficacy of meloxicam and 15 m Timepoints:5 day—

Secondary

MeasureTime frame
Outcome name:Incidence of Adverse Gastro-Intestinal Events. Perforations, ulcerations, bleeding (PUB) of the upper gastrointestinal tract. Incidence of Any Adverse Event and Relation to the Trial Drug. Intensity of adverse events Measure:Security will be determined and compared between the different groups Timepoints:5 days—

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)