An Efficacy and Safety Study of Theraflu Night Powder as Oral Solution for Cold and Flu
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|ClinicalTrials.gov Identifier: NCT02730364|
Recruitment Status : Withdrawn (The clinical phase of the study (from FSFV to LSLV) was never initiated due to the sponsor's decision.)
First Posted : April 6, 2016
Last Update Posted : March 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infections, Respiratory Tract||Drug: Paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin C||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||This was an open label study.|
|Official Title:||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|
|Estimated Study Start Date :||February 1, 2017|
|Estimated Primary Completion Date :||April 1, 2017|
|Estimated Study Completion Date :||April 1, 2017|
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 Name: Theraflu Night powder for oral solution
No Intervention: No Treatment
Participants in this arm will not receive any medication
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730364
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|