A Phase III, Multicenter, Double-blind, Randomized, Parallel-group Non-inferiority Clinical Trial to Evaluate the Efficacy and Safety of a Fixed-dose Combination of 1000 mg Dipyrone Monohydrate + 60 mg Caffeine + 4 mg Chlorpheniramine Maleate Compared to Benegrip® in Improving Symptoms of the Common Cold and Flu in Adult Participants
Phase III clinical trial to evaluate the efficacy and safety of a fixed-dose combination of 1000 mg dipyrone monohydrate + 60 mg caffeine + 4 mg chlorpheniramine maleate in improving symptoms of the common cold and flu in adults.
• The following criteria must be met for the participant to be included in the study:
‣ Participants of both sexes, aged between 18 and 60 years.
⁃ Be able to understand, agree to participate in the study, comply with procedures, and attend visits, as indicated by signing the informed consent form (ICF) approved by the Ethics Committee.
⁃ Present symptoms of nasal obstruction and/or congestion due to the common cold or influenza, with onset within less than 48 hours, with symptoms classified by the participant as moderate to severe on a 4-point scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).
⁃ Must not have used any medication for symptomatic treatment of the condition.
⁃ Female participants without childbearing potential, defined as postmenopausal women (defined as 12 months or more of amenorrhea) or those who have undergone surgical sterilization\*, OR female participants with reproductive potential who agree to use a reliable contraceptive method\*\*.
‣ \* Female sterilization (bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation performed at least 6 weeks before administration of the investigational product.
‣ \*\* If the participant is of childbearing potential and decides to participate in the study, she must use or request that her partner use a reliable contraceptive method. Reliable contraception is defined as the use of at least one of the following: condoms, diaphragm, and/or hormonal contraceptive methods (estrogenic and/or progestogenic), including oral, vaginal, injectable, transdermal, implantable, and intrauterine devices. Only participants who explicitly declare no risk of pregnancy, either due to not engaging in sexual activity or engaging exclusively in non-reproductive practices, may participate without mandatory contraceptive use; for example: participants with a sterile or vasectomized partner (at least 6 months before screening), or total heterosexual abstinence.