Not yet recruiting NCT06272409
Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DEP114, Desloratadine 0.5 MG/ML.
- Who it may be relevant to
- Registry conditions: Allergic Rhinitis. Basic parameters: 6 years — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase III, Multicenter, Double-blind, Planned, Parallel Clinical Trial to Evaluate the Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children Aged Between 6 and 11 Years
Overview
The purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years.
Detailed description
* double-blind, superiority, parallel group trial. * Experiment duration: 05 days. * 03 visits (days 0, 5 and 28). * Efficacy will be evaluated for persistent allergic rhinitis based on Global improvement in nasal symptoms score * Adverse events evaluation.
Interventions
- Drug DEP114
DEP114 oral solution - Drug Desloratadine 0.5 MG/ML
Desloratadine oral solution
Primary outcome measures
- To demonstrate the superiority of DEP114 in relation to desloratadine 0.5 mg/mL in relieving the nasal symptoms of moderate to severe persistent allergic rhinitis in children, five days after starting treatment. [Time frame: 5 days]
Secondary outcome measures (7)
- To evaluate the effectiveness of DEP114 in relieving nasal symptoms of moderate to severe persistent allergic rhinitis in children, throughout the treatment. [Time frame: 1-5 days]
- Evaluate the efficacy of DEP114 to relieve nasal obstruction present in moderate to severe persistent allergic rhinitis in children through the treatment. [Time frame: 1-5 days]
- Evaluate the efficacy of DEP114 to relieve coryza present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment. [Time frame: 3 and 5 day]
- Evaluate the efficacy of DEP114 to relieve nasal itching present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment. [Time frame: 3 and 5 day]
- Evaluate the efficacy of DEP114 to relieve sneezing present in persistent allergic rhinitis moderate to severe in children, three and five days after the start of treatment. [Time frame: 3 and 5 day]
- Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the perception of the person responsible for the participant. [Time frame: 5 day]
- Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the investigator's perception. [Time frame: 5 day]
Eligibility criteria
Inclusion criteria
- Ability to confirm voluntary participation and agree for all the purposes of the test, signing and dating the Term of Free and Informed Assent (TALE), signed by the Free and Informed Consent Form (TCLE) by responsible;
- Age ≥ 6 years and ≤ 11 years on the day of signing the TALE and the TCLE by the person responsible;
- Diagnosis of moderate to severe persistent allergic rhinitis (PAR) according to the criteria of Allergic Rhinitis and its Impact on Asthma (ARIA);
- Presence of sensitization to aeroallergens confirmed by positive result to the immediate reading skin test (PRICK test) and/or the presence of specific IgE to the test radioallergoabsorbent (RAST);
- Symptom intensity score "nasal obstruction" ≥ 2 points.
- Total nasal symptoms score (TNSS) ≥ 8 points.
Exclusion criteria
- Use of prednisolone or other oral or parenteral corticosteroid in the seven (07) days prior to inclusion;
- Use of H1 antihistamine, anti-leukotriene and decongestant topic in the seven (07) days prior to inclusion;
- Use or indication for the use of antibiotics at the screening visit and randomization;
- Presence of adenoid hypertrophy or anatomical disorders known obstructive disorders (e.g. septal deviation) that may be held responsible for nasal obstruction, at the discretion of the investigator;
- Diagnosis of severe or uncontrolled asthma;
- Allergy to desloratadine, prednisolone or any other component of the formulation of investigational products (PSIs);
- Presence of systemic fungal infection;
- Presence of any uncontrolled infection;
- Presence of any clinical observation finding (evaluation clinical/physical) or laboratory condition that is interpreted by the investigator physician as a risk to participation in the trial clinical or presence of serious uncontrolled disease(s);
- Participants who are pregnant or breastfeeding;
- Participation in clinical trial protocols in the last 12 (twelve) months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator believes that there may be direct benefit to the participant.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06272409 · DEP114-III-0123