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

March 9, 2018 updated by: GlaxoSmithKline

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 + Pheniramine Maleate 20 mg + Vitamin C 200 mg Powder for Oral Solution in Subjects With Symptoms of an Upper Respiratory Tract Infection

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".

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • 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
  • 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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Theraflu night powder
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
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.
Other Names:
  • Theraflu Night powder for oral solution
No Intervention: No Treatment
Participants in this arm will not receive any medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy assessment Change from baseline, 3 hours after dosing in the Jackson Total Symptom Score (JTSS)
Time Frame: At 3 hours post dosing
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2017

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimate)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205637

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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