Infections, Respiratory TractPhase 3NCT02730364
An Efficacy and Safety Study of Theraflu Night Powder as Oral Solution for Cold and Flu
A Phase 3 study testing Paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin C in people with Infections, Respiratory Tract, run by GlaxoSmithKline.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Respiratory Tract
- What is being tested?
- Paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2017to 1 Apr 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
About this 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
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
- Being tested
- Paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin C
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin CDrug
Also called Theraflu Night powder for oral solution
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin C |
| No Treatment | No intervention | Participants in this arm will not receive any medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 3 hours post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study start1 Feb 2017 (estimated)
- Primary completion1 Apr 2017 (estimated)
- Study completion1 Apr 2017 (estimated)
Why it stopped: The clinical phase of the study (from FSFV to LSLV) was never initiated due to the sponsor's decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, Respiratory TractStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730364
- Sponsor's protocol ID
- 205637
- Status last verified
- Mar 2018
- First submitted
- 1 Feb 2016
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02730364
- Acronym / sponsor ID
- 205637
- Conditions
- Infections, Respiratory Tract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The clinical phase of the study (from FSFV to LSLV) was never initiated due to the sponsor's decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (estimated)
- Primary completion
- 1 Apr 2017 (estimated)
- Study completion
- 1 Apr 2017 (estimated)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theraflu night powder | Experimental | Drug: Paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin CParticipants will receive a single dose (1 sachet) of Theraflu Night powder containing paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin C as oral solution. |
| No Treatment | No intervention | –Participants in this arm will not receive any medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin CAlso: Theraflu Night powder for oral solutionOne sachet is provided for each participant randomized to the Theraflu Night powder containing paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin C as oral solution. | Drug | Theraflu night powder |
Primary outcome
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).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin C in people with Infections, Respiratory Tract, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy assessment Change from baseline, 3 hours after dosing in the Jackson Total Symptom Score (JTSS) (time frame: At 3 hours post dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.