Overview

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

Status:
Withdrawn
Trial end date:
2017-04-01
Target enrollment:
0
Participant gender:
All
Summary
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".
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Acetaminophen
Ascorbic Acid
Dextromethorphan
Oxymetazoline
Pharmaceutical Solutions
Phenylephrine
Vitamins
Criteria
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)