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

NCT02730364 | Withdrawn Phase 3

• 1 other identifier: 205637
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to assess the short term efficacy of the Theraflu Night powder for oral solution in the Russian population in "Short term relief of the symptoms of colds, chills and influenza, including mild to moderate pain, fever and nasal congestion".

Conditions

Infections, Respiratory Tract

Outcome Measures

Primary Outcomes (1)

• Efficacy assessment Change from baseline, 3 hours after dosing in the Jackson Total Symptom Score (JTSS)

  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).

  At 3 hours post dosing

Study Arms (2)

Theraflu night powder

EXPERIMENTAL

Participants will receive a single dose (1 sachet) of Theraflu Night powder containing paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin C as oral solution.

Drug: Paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin C

No Treatment

NO INTERVENTION

Participants in this arm will not receive any medication

Interventions

Paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin C DRUG

One sachet is provided for each participant randomized to the Theraflu Night powder containing paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin C as oral solution.

Also known as: Theraflu Night powder for oral solution

Theraflu night powder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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 anaesthetic, 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Acetaminophen; Oxymetazoline; Pheniramine; Ascorbic Acid; Solutions

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates; Pharmaceutical Preparations

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: April 6, 2016
• Study Start: February 1, 2017
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 12, 2018

Record last verified: 2018-03