EFFICACY AND SAFETY OF 200 MCG OR 400 MCG OF MOMETHASONE FUROATE NASAL SPRAY OR PLACEBO IN THE TREATMENT OF ACUTE SINUSITIS EPISODES

Not Applicable

• Conditions: -J01; J01

• Registration Number: PER-012-01
• Lead Sponsor: SCHERING PLOUGH RESEARCH INSTITUTE,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-03-23
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• The subjects must have a clinical diagnosis of acute sinusitis, that is, they must have a Total Symptom Score of> 6 and at least one of the following specific symptoms of sinusitis (score> 1): Purulent rhinorrhea lasting at least 7 days before the Randomization Visit but no more than 28 days; Pain / facial pressure or abnormal sensation of touch in the sinuses; Postnasal drip; Headache of sinus origin.
• The subjects must be at least 12 years of age, belong to any sex or race and weigh> 40 kg.
• The computed tomography performed at the Screening Visit must show sinusitis before the randomization to the study drug
• The subjects must be in good health, without any clinically significant disease (other than sinusitis) that could interfere with the procedures or the study schedule, or endanger the safety of the subject.
• Subjects (and / or their parents / guardians) must give written informed consent. They must be able to comply with the schedules of visits and doses.
• The serum pregnancy test must be negative at the start.
• Women should be using a medically accepted method of contraception, ie a double-barrier method, oral contraceptive, Depo-Provera® or Norplant®, before Screening and during the study. Vasectomy and tubal ligation should be considered as unique barrier methods. Women of childbearing age should receive guidance on the appropriate use of contraceptive methods while participating in this study. Women who do not currently have sexual intercourse should agree to use one of the methods mentioned above should they become sexually active during the course of their participation in this study.
• Subjects must have reported at least one previous episode of acute sinusitis within two years prior to the Screening Visit, but not within four weeks prior to the beginning of the current episode.

Exclusion Criteria

• Subjects with computed tomography that does not show sinusitis at the beginning.
• Subjects with invasive diseases such as meningitis, brain abscesses, orbital cellulitis, osteomyelitis, septicemia or cerebral venous sinus thrombosis.
• Subjects with other associated complications of sinusitis, which at the investigator´s discretion would place the subject at risk or interfere with the conduct of the study.
• Subjects in whom sinus or nasal surgery is planned within the next three weeks or in which nasal or sinus surgery was performed within the previous year.
• Subjects with a history of chronic sinusitis treated with antibiotics for 28 days or longer or current episode of sinusitis lasting more than 28 days.
• Women of childbearing age who are not using an acceptable contraceptive method.
• Pregnant women or those who are breastfeeding.
• Subjects that have used a drug in the research phase in the last 30 days prior to the Selection.
• Subjects with cystic fibrosis, nasal polyps visible on the physical examination, deviation of the clinically significant nasal septum, Kartagener´s syndrome (immobile lashes) or immunocompromised subjects due to conditions that may interfere with the evaluation of the efficacy or safety of the patient. treatment.
• Subjects with unstable glaucoma, a history of posterior subcapsular cataract, cardiovascular, pulmonary, renal, hepatic, metabolic, hematologic or neurological clinically significant diseases that, in the opinion of the Investigator, could interfere with the assessment of the safety of the treatment.
• Subjects with any clinically significant abnormal vital sign at onset or with clinically significant abnormal electrocardiographic findings.
• Subjects who are allergic to corticosteroids, penicillins, or who are allergic to more than two classes of medications (eg, anaphylactic reaction).
• Subjects who have not complied with the depuration times of the medication listed in section 3.4.3.2 before randomization.
• Concurrent need for treatment with another antibiotic other than Augmentin®.
• Study staff, or subjects directly related to the study staff.
• Subjects that have been randomized prior to treatment with the study drug.
• Subjects without full capacity to grant informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified