[Topical therapy of acute nociceptive pain: results of an open randomized clinical trial of the domestic drug Alental cream]. / Topicheskaya terapiya ostroi notsitseptivnoi boli: rezul'taty otkrytogo randomizirovannogo klinicheskogo issledovaniya otechestvennogo preparata Alental' krem.

OBJECTIVE: Evaluation of the therapeutic efficacy, safety and tolerability of the drug Alental cream for external use (VERTEX, LLS, Russia) compared with the original drug - Aertal cream for external use (Gedeon Richter, LLS, Hungary) for local therapy of acute nociceptive pain syndrome in patients who have suffered traumatic ankle injury. MATERIAL AND METHODS: The study included 131 patients who had suffered an injury to the soft tissues of the ankle joint. The 1st comparison group received the drug Alental cream, the 2nd group - Aertal cream. The duration of therapy was 7 days. The effectiveness of the drugs was evaluated during treatment based on the dynamics of the intensity of pain syndrome and other symptoms of trauma, as well as the assessment of these changes by the doctor and the patient. The safety analysis included the registration of adverse events according to clinical and laboratory studies. RESULTS: Alental cream in terms of therapeutic efficacy was equivalent to the registered original preparation Aertal cream. The analysis of the assessment of the dynamics of clinical and laboratory parameters, the safety of treatment, including the frequency of adverse events, did not reveal significant differences between the two drugs. CONCLUSIONS: Alental cream can be used as a means for local therapy of acute nociceptive pain syndrome in traumatic soft tissue injuries.

[Results of an open, randomized, actively controlled study of the efficacy and safety of the new drug Freinozole nasal spray (Phenylephrine + Cetyrizine) in patients with acute respiratory infection]. / Rezul'taty otkrytogo randomizirovannogo aktivno-kontroliruemogo issledovaniia éffektivnosti i bezopasnosti novogo lekarstvennogo preparata Frinozol sprei nazal'nyi (Feniléfrin + Tsetirizin) u patsientov s ostroi respiratornoi infektsiei.

The aim of the study was proof of efficacy and safety of the drug Frinozol nasal spray in patients with acute respiratory infection (acute rhinitis). PATIENTS AND METHODS: A randomized open-label study with active control included 134 ambulatory patients: men and women aged 18 to 65 years with acute upper respiratory tract infection (acute rhinitis) lasting no more than 48 hours before inclusion into the study. Patients were randomized in two groups: group 1 took Frinozol nasal spray 2 sprays per each nostril three times a day for 7 days, subjects randomized to the group 2 took Vibrocil at the same dose and treatment regimen. The primary efficacy endpoint in the study was assessment of the dynamics of symptoms such as nasal congestion, rhinorrhea, itching in the nose and hyposmia using 10 cm VAS in 1 day after the start of treatment compared to the baseline. Secondary endpoints included assessment of the dynamics of nasal symptoms after 7 days of treatment, changes in the values of the Congestion Quantifier 5, CQ-5 questionnaire and evaluation of the effectiveness by the investigator. Safety analysis was carried out throughout the study and included the assessment of adverse events, laboratory data, vital signs, ECG assessment. RESULTS: According to the results of the study and comparative analysis of the primary (assessment of the dynamics of nasal symptoms on a 10 cm visual analogue scale 1 day after the start of treatment) and secondary efficacy endpoints as well as a comprehensive safety analysis, it can be concluded that the study drug is not inferior to the reference drug. Thus, the new combination Frinozol nasal spray is an effective and safe treatment for patients with acute respiratory infections.