None listed
Conditions
Interventions
Group 1 Type of group
SCH 3411 (desloratadine) 75mg QD-AM
Group name:Group 2 Type of group
Placebo corresponding to the study medication QD-AM
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients must be 12 years of age or older, and can be both sexes and any race. • They must have at least 2 years of documented history of symptoms of moderate perennial allergic rhinitis. • They must have a positive response to a skin test (prick or intradermal) with an appropriate perennial allergen within 12 months prior to the Visit 1. IgE-mediated hypersensitivity to an appropriate perennial allergen must be confirmed by either positive response to prick skin test with a welt diameter at least 3 mm larger than -the-control with the patient or a positive response to an intradermal paieba with a welt diameter at least 7 mm larger than the control with the diluent. • The nasal obstruction / congestion in the filtrate should be 10) to meet the eligibility conditions (see Section 3.5.2.10). • For the three calendar days prior to the start, the six reflective scores of the congestion diary obtained from two records per day during the period between the selection and the start must total <12 and the total score of Symptoms will be at least 60. • The patient must have a good general state of health confirmed by laboratory tests and routine clinics. Clinical laboratory tests (complete blood count, blood chemistry, urinalysis) must be within normal or clinically acceptable limits for the Investigator / Sponsor. • Patients should not have any clinically significant disease, in addition to perennial rhinitis, that could interfere with the study evaluations. • The patient and / or the parent / guardian must be willing to grant written informed consent and must be able to comply with visit and dose schedules and study requirements. • For women of childbearing age, the serum pregnancy test (HCG) must be negative at the time of filtering. • All premenopausal and non-hysterectomized women should be using a clinically accepted contraceptive method, that is, a double barrier method, oral contraceptives, Depo-Provera® or Norplant®. Before the selection and during the study. The absence of menstruation for at least one year will indicate that a woman is postmenopausal. Tubal ligation will be considered a simple barrier. Women of childbearing age should receive advice as to the appropriate use of a contraceptive method while participating in this study. Women who do not currently have an active sex life must agree to use one of the methods mentioned above in case of having an active sex life in the course of their participation in this study.
Exclusion criteria
Exclusion criteria: • Patients with seasonal allergic rhinitis caused by an allergen that is pollinating while the patient participates in the study. • Asthmatic patients requiring chronic use of systemic or inhaled corticosteroids. • Patients with chronic purulent postnasal drip or frequent clinically significant sinusitis, or with a history of such conditions. • Patients with drug rhinitis. • Patients with a history of allergy to more than two kinds of medication or who are allergic to antihistamines or do not tolerate them. • Patients who have had a sinus or upper respiratory tract infection that has required antibiotic treatment within 14 days prior to filtering, or who have had a viral infection of the upper respiratory tract within 7 days prior to filtering. • Patients with structural nasal abnormalities, including large nasal polyps and a marked deviation of the septum, that significantly interfere with the flow of nasal air. • Patients who, in the opinion of the Researcher, are dependent on nasal, oral or ocular decongestants, nasal topical application antihistamines or nasal asteroids. • Patients who have used a drug in the investigation phase during the last 30 days prior to filtering. • Patients receiving immunotherapy (desensitization), unless they are in a regular maintenance program before the filtering visit and maintain this program for the rest of the study. Patients cannot receive desensitization treatment within 24 hours prior to a follow-up visit. • Pregnant or breastfeeding women. • Patients with a history of hypersensitivity to the study drugs or their excipients. • Research staff members or family members of Research staff participating in this study. • Patients with prior randomization in this study. • Patients with current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurological, psychiatric or autoimmune disease or another disease that prevents the patient´s participation in the study. Special attention should be given to patients with disorders that may currently interfere with the absorption, distribution, metabolism or excretion of the study medication or with the patient´s ability to reliably complete the diary. • Patients whose ability to grant informed consent is affected. • Patients with a history of non-compliance related to the administration of medications or treatment protocols.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:obtained from the diary and defined as the sum of all individual symptom scores, excluding nasal obstruction / congestion, expressed as modification from baseline, and the primary time point is the average during the first two weeks of treatment. Measure:Total score of average morning-evening reflexive symptoms Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Frequency tabs and summary statistics for the following safety parameters will be provided: to. Incidence of adverse effects arising from treatment. b. Separation of study subjects due to adverse effects. c. Changes in vital signs with respect to the Start. d. Changes in the results of laboratory tests with respect to Start. Measure:routine security Timepoints:During the study | — |
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERÚ S.A.
Outcome results
None listed