An Efficacy and Safety Study of Theraflu Day Powder as Oral Solution for Cold and Flu

Study Overview
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Brief Summary
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The purpose of the study is to assess the short term efficacy of the Theraflu Aktiv powder for oral solution in the Russian population as compared to an untreated group to support the indication of Short term relief of the symptoms of colds, chills and influenza, including mild to moderate pain, fever and nasal congestion.

Official Title
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An Open-label, Multicenter, Randomized, Parallel Group, Single-dose Study to Assess the Short Term Efficacy and Safety of Paracetamol 500 mg + Phenylephrine HCl 10 mg + Vitamin C 200 mg Powder for Oral Solution in Subjects With Symptoms of an Upper Respiratory Tract Infection

Conditions
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Infections, Respiratory Tract

Intervention / Treatment
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* Drug: Paracetamol, phenylephrine HCl, and vitamin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must understand and provide written informed consent before any assessment is performed, understand the study procedures, and be willing and able to complete the required assessments Males and females ≥ 18 years Clinical diagnosis of a URTI as diagnosed by the investigator which would be classified as ICD-10 code J00 (acute nasopharyngitis common cold) Mild to moderate sore throat, i.e. rated as 1 or 2 on a 4-point ordinal scale (0=not present, 1= mild, 2=moderate, 3=severe), or headache (1, 2 or 3) or fever (less than 39°C ) or/and Nasal congestion (blocked nose): may be accompanied by rhinorrhea (runny nose) and/or sneezing Baseline Jackson TSS > 8 Common cold symptoms for less than 48 hours Exclusion Criteria: Use of other investigational drugs within 30 days or 5 half-lives of enrollment, whichever is longer. Investigational drug refers to any drug being evaluated in clinical trials History of or known hypersensitivity to any of the study drugs, excipients or to drugs of similar chemical classes Sacharoze/maltose deficiency, fructose intolerance, glucosegalactose malabsorbtion Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL) or urine dipstick at baseline Any history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis. participants with uncomplicated seasonal allergic rhinitis can be accepted if expected allergy season is clearly one month outside enrollment/ treatment period Any history of brain diseases, liver diseases or epilepsy Any evidence of uncontrolled cardiovascular (including hypertension), pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinological, metabolic, neurological or psychiatric diseases at screening Subject has closed angle glaucoma, urinary retention, prostatic hyperplasia, pyloroduodenal obstruction, pheochromocytoma, diabetes mellitus A positive alcohol breath test or positive urine drug screen or a medical history data indicative of alcoholism, drug addiction, or drug abuse within the preceding 2 years Subject is current smoker of ≥10 cigarettes per day (or reports equivalent smoking habits using other tobacco products) and is unwilling to refrain from smoking while at the study site Subject is current smoker of ≥10 cigarettes per day (or reports equivalent smoking habits using other tobacco products) and is unwilling to refrain from smoking while at the study site Subject is taking or has taken within the last two weeks of dosing monoamine oxidase inhibitors, antidepressants, atropine, beta-blocking or sympathomimetic drugs desferrioxamine, hepatotoxic drugs, drugs inducing liver microsomal enzyme, (such as phenytoin, carbamazepine, isoniazid and rifampicin), neuroleptic drugs, chlorzoxazone, CNS depressant drugs including barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives, antipsychotics or is anticipated to require any of these medications at any time throughout the study Subject has used: Systemic or topical corticosteroids (with the exception of HRT and contraceptive steroids for females), within 3 weeks prior to dosing or Slow-release steroids (with the exception of HRT and contraceptive steroids for females) within 90 days prior to dosing Subject has used any of the following medications within 6 hours before first study drug administration, or is anticipated to use any of these medications at any time throughout the study: Any inhaler, medicated confectionary, throat lozenges, throat pastilles, sprays, any products with demulcent properties such as chewing gums and boiled sweets or mints, Any medication for sore throat containing a local anesthetic, Cold products and oral nasal decongestant products, Paracetamol or any NSAID Subject has used substances of abuse, herbal medicines, antihistamines and homeopathic medicine within 72 hours of dosing or is anticipated to require any of these drugs at any time throughout the study Subject was previously enrolled into the current study Persons directly or indirectly involved in the execution of this protocol, including first-degree relative of a study investigator, employees of the clinical study site, employees of the CRO and persons related to them Vulnerable individual (as defined by the IRB e.g. incarcerated person)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Theraflu Aktiv powder for oral solution<br>Participants in this arm will receive a single dose (1 sachet) of Theraflu Aktiv powder for oral solution | Drug: Paracetamol, phenylephrine HCl, and vitamin C<br>* One sachet is provided for each participant randomized to the Theraflu Aktiv powder for oral solution<br>* Other names: Theraflu Aktiv powder for oral solution;|
| No Intervention: No Treatment<br>Participants in this arm will not receive any medication | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy assessment | The severity of common cold symptoms will be self-assessed using the Jackson 8 items scale (questionnaire) by the participants on the site. This questionnaire measures the severity of 5 local symptoms (nasal congestion, rhinorrhea, sneezing, cough, and sore throat) and 3 systemic symptoms (chilliness, headache, malaise) each on a 4-point ordinal scale (0=not present, 1= mild, 2=moderate, 3= severe). | Baseline and 3 hours post dosing |