CTRI/2022/11/047718已完成3 期
â??A Phase III, Prospective, Randomized, Double Blind, Active-Controlled, Comparative, Parallel Group, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Fexofenadine 60 mg plus Montelukast 4 mg Oral Suspension Versus FDC of Levocetirizine 2.5 mg plus Montelukast 4 mg Oral Suspension in Patients with Allergic Rhinitis.â??
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 196
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female patients aged between 6 and 11 years (both inclusive).
- •2. Patients with a history of allergic rhinitis, a positive skin prick test to at least one relevant allergen and active symptoms of allergic rhinitis at study entry.
- •3. Patients with elevated serum IgE levels ( >100 IU/mL) at screening or baseline visit.
- •4. Patients with Total Nasal Symptom Score (TNSS) at screening or baseline >= 4.
- •5. Patients with ability to understand and provide oral assent in the presence of parent / legally acceptable representative, which must have been obtained prior to screening.
- •6. Patients willing to comply with the protocol requirements.
排除标准
- •1. Patients with hypersensitivity to either of the study medications or any of the ingredients of the formulation.
- •2. Patients with Electrocardiographic abnormalities including conduction delay and an abnormal QTc interval.
- •3. Patients with upper respiratory tract infections including cold and systemic infections within 3 weeks of baseline/screening visit.
- •4. Patients with history of renal, hepatic, gastrointestinal tract, cardiovascular, respiratory, haematological, endocrine or neurological diseases.
- •5. Patients with clinically significant impaired hepatic function [SGOT & SGPT more than 2.5X the UNL].
- •6. Patients who had initiation of allergen immunotherapy within previous 6 months.
- •7. Patients with history of Rhinitis medicamentosa, non-allergic rhinitis or substantial structural nasal obstruction.
- •8. Patients with history of nasal polyps or any clinically important nasal anomaly.
- •9. Patients with history of acute and/or chronic sinusitis within 30 days of baseline/screening visit.
- •10. Patients with history of eye surgery or intranasal surgery within 3 months of baseline/screening visit.
- •11. Patient with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 months before the trial.
- •12. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to screening visit.
- •13. Patients currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
- •14. Suspected inability or unwillingness to comply with the study procedures.
- •15. Patients with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
研究者
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