Common ColdPhase 4NCT02246166

The Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza.

A Phase 4 study testing Test tablet in people with Common Cold, run by GlaxoSmithKline at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Common Cold
What is being tested?: Test tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 53 participants
Where: 2 sitesChina
Study dates: Jan 2015to Feb 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged at least 18 years and less than 65 years
Good general and mental health in the opinion of the investigator
Participants diagnosed with a common cold or flu and must have the following symptoms of at least "moderate" in intensity (≥ 2) at the screening visit (baseline), with a minimum total symptom score of 6:
At least one of pain symptoms: sore throat, headache, or extremities pain (ii) Mandatory: Nasal congestion (iii) At least one of catarrh symptoms: runny nose or sneezing
Onset of first symptoms of cold must have occurred within 48 hours of screening.

Who cannot join

Pregnant or breast feeding women
History of seasonal or perennial allergic rhinitis or acute, sub-chronic, or chronic cough due to any condition other than a common cold or flu, as determined by the investigator
Concurrent illness or medical history that is contraindicated or cautioned about in the drug label
Anatomical factors causing nasal congestion
Fever with body temperature >38.5°C at baseline
Have used any medication or herbal remedies to treat cold prior to screening (antibiotics in the last 7 days, antihistamines in the last 72 hours, analgesics or antipyretics in the last 24 hours, decongestant in the last 12 hours, antitussive, medicated lozenge or throat spray in the last 8 hours)

Show all 9Show fewer

Any medication that has potential drug-drug interactions with study medications
Known or suspected intolerance or hypersensitivity to the study materials
Have a positive drug urine test or recent history (within the last 2 years) of alcohol or other substance abuse

Trial locations and contacts

2 sites in 1 country.

China2 sites

GSK Investigational Site
Shanghai, 200025
GSK Investigational Site
Shanghai, 200120

Other trials in China

About this study

Official title: A Double-Blind, Randomised, Placebo-Controlled, Parallelgroup, Single-Dose Study to Evaluate Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza Over a 4 Hour Period

This phase IV multi-centre, randomised, double-blind, placebo-controlled, parallel-group, single-dose study will assess the efficacy and tolerability of the active tablets versus placebo in participants suffering from cold and influenza. Eligible participants will be randomly assigned to one of 2 treatment groups (active or placebo tablets) and enter a four-hour (hr) treatment phase. Each participant will be administered only once during each study period. Participants will use a questionnaire to record the symptom severity scores as described, as well as time.

Conditions: Common Cold
Being tested: Test tablet, Placebo
Medical subject headings: Common Cold

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Test tabletDrug
The active tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity
PlaceboOther
The placebo tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity

Study groups in NCT02246166
Study group	Role	What they receive
Test tablet	Experimental	Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg). Receives: Drug: Test tablet
Placebo	Placebo comparator	Matching placebo tablet Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Symptom Severity Assessment at 15 Minutes
Symptom severity assessment was determined by Total Sum Score (TSS), TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 15 minutes post product use.
Measured: 15 minutes
Symptom Severity Assessment at 30 Minutes
Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 30 minutes post product use.
Measured: 30 minutes
Symptom Severity Assessment at 1 Hour
Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 1hour post product use.
Measured: 1 hour
Symptom Severity Assessment at 2 Hours
Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 2 hours post product use.
Measured: 2 hours
Symptom Severity Assessment at 3 Hours
Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 3 hours post product use.
Measured: 3 hours
Symptom Severity Assessment at 4 Hours
Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure.
TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration.
Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 4 hours post product use.
Measured: 4 hours

Secondary outcomes (9)

Global Assessment of Treatment
After completing the 4 hours symptom severity assessments, participants evaluated their treatment response on a 5-point scale by answering the question: "How well did the test medication control your symptoms?" (0-ineffective, 1-poor, 2-fair, 3-good, or 4-excellent).
Measured: 4 hours
Sore Throat Severity Assessment
Participants self-assessed sore throat severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sore throat severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
Measured: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Headache Severity Assessment
Participants self-assessed headache severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All headache severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
Measured: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Extremities Pain Severity Assessment
Participants self-assessed extremities pain severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All extremities pain severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
Measured: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Nasal Congestion Severity Assessment
Participants self-assessed nasal congestion severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All nasal congestion severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
Measured: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Runny Nose Severity Assessment
Participants self-assessed runny nose severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All runny nose severity assessment values were recorded in questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
Measured: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Sneezing Severity Assessment
Participants self-assessed sneezing severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All sneezing severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
Measured: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Cough Severity Assessment
Participants self-assessed cough severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at baseline and at 15, 30, 60, 120,180 and 240 minutes post product administration. All cough severity assessment values were recorded in a questionnaire and tabulated. A reduction in severity score from baseline represented a better outcome measure.
Measured: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Body Temperature Reduction
Summary statistics for body temperature was presented at baseline and at 15, 30, 60, 120,180 and 240 minutes post treatment. Wilcoxon Rank Sum test was used to investigate if there are any significant treatment differences.
Measured: Change from baseline in 15, 30, 60,120, 180, and 240 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Feb 2015

First posted22 Sep 2014 (estimated)
Study startJan 2015
Primary completionFeb 2015
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Common ColdStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02246166
Sponsor's protocol ID: 202271
Other IDs: RH02565
Status last verified: May 2016
First submitted: 18 Sep 2014
Last updated: 14 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomised, Placebo-Controlled, Parallelgroup, Single-Dose Study to Evaluate Effect of Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets Compared to Placebo in Subjects Suffering From the Common Cold or Influenza Over a 4 Hour Period
ClinicalTrials.gov ID: NCT02246166
Acronym / sponsor ID: 202271
Conditions: Common Cold
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Collaborators: Sino-American Tianjin Smith Kline & French Laboratories Ltd
Study start: Jan 2015
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 22 Sep 2014 (estimated)
Results: Posted 21 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Test tablet	Experimental	Drug: Test tabletTablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
Placebo	Placebo comparator	Other: PlaceboMatching placebo tablet

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Aged at least 18 years and less than 65 years
Good general and mental health in the opinion of the investigator
Participants diagnosed with a common cold or flu and must have the following symptoms of at least "moderate" in intensity (≥ 2) at the screening visit (baseline), with a minimum total symptom score of 6:
Onset of first symptoms of cold must have occurred within 48 hours of screening.

Key exclusion criteria (9 listed)

Pregnant or breast feeding women
History of seasonal or perennial allergic rhinitis or acute, sub-chronic, or chronic cough due to any condition other than a common cold or flu, as determined by the investigator
Concurrent illness or medical history that is contraindicated or cautioned about in the drug label
Anatomical factors causing nasal congestion
Fever with body temperature >38.5°C at baseline

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
Test tabletThe active tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity	Drug	Test tablet
PlaceboThe placebo tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity	Other	Placebo

Primary outcome

Symptom Severity Assessment at 15 Minutes
Time frame: 15 minutes
Symptom severity assessment was determined by Total Sum Score (TSS), TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure. TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration. Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 15 minutes post product use.
Symptom Severity Assessment at 30 Minutes
Time frame: 30 minutes
Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure. TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration. Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 30 minutes post product use.
Symptom Severity Assessment at 1 Hour
Time frame: 1 hour
Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure. TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration. Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 1hour post product use.
Symptom Severity Assessment at 2 Hours
Time frame: 2 hours
Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure. TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration. Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 2 hours post product use.
Symptom Severity Assessment at 3 Hours
Time frame: 3 hours
Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure. TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration. Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 3 hours post product use.
Symptom Severity Assessment at 4 Hours
Time frame: 4 hours
Symptom severity assessment was determined by TSS, TSS ranged from 0 to 21 with less severity score at the given time point represented a better outcome measure. TSS was calculated as the sum of the non missing scores (all on a 0-3 scale measuring worsening or severity) of the following common cold symptoms: sore throat, headache, extremities pain, nasal congestion, runny nose, sneezing, and cough post treatment administration. Participants self assessed symptoms severity using 4 points (0 = absent, 1 = mild, 2 = moderate, and 3 = severe) categorical scale at 4 hours post product use.

9 secondary outcomes

Global Assessment of Treatment
Time frame: 4 hours
Sore Throat Severity Assessment
Time frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Headache Severity Assessment
Time frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Extremities Pain Severity Assessment
Time frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Nasal Congestion Severity Assessment
Time frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Runny Nose Severity Assessment
Time frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Sneezing Severity Assessment
Time frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Cough Severity Assessment
Time frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes
Body Temperature Reduction
Time frame: Change from baseline in 15, 30, 60,120, 180, and 240 minutes

Results and safety

Results posted to the registry on 21 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Tablet	26	25
Placebo	27	27

Primary outcome: Symptom Severity Assessment at 15 Minutes

Time frame: 15 minutes. Least squares mean (Standard Error). Unit: Score on scale

Measure	Test Tablet n = 25	Placebo n = 27
Observed value	10.66 (0.309)	10.64 (0.304)
Change from baseline	-1.11 (0.309)	-1.13 (0.304)

Test Tablet vs Placebo: Mean Difference (Final Values): 0.03 (95% CI -0.77 to 0.83), p = 0.9473, ANCOVA

Population analysed: The primary population for assessment of efficacy was the intent to treat (ITT) population. The ITT population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.

Primary outcome: Symptom Severity Assessment at 30 Minutes

Time frame: 30 minutes. Least squares mean (Standard Error). Unit: Score on scale

Measure	Test Tablet n = 25	Placebo n = 27
Observed value	9.55 (0.402)	9.74 (0.396)
Change from baseline	-2.22 (0.402)	-2.03 (0.396)

Test Tablet vs Placebo: Mean Difference (Final Values): -0.19 (95% CI -1.23 to 0.86), p = 0.7210, ANCOVA

Population analysed: The primary population for assessment of efficacy was the intent to treat (ITT) population. The intent-to-treat (ITT) population was defined as all participants who were randomized and received at least one dose of treatment during the study and provide at least one post baseline assessment of efficacy.

Primary outcome: Symptom Severity Assessment at 1 Hour

Time frame: 1 hour. Least squares mean (Standard Error). Unit: Score on scale

Measure	Test Tablet n = 25	Placebo n = 27
Observed value	8.73 (0.495)	8.52 (0.487)
Change from baseline	-3.04 (0.495)	-3.25 (0.487)

Test Tablet vs Placebo: Mean Difference (Final Values): 0.21 (95% CI -1.07 to 1.49), p = 0.7445, ANCOVA

Primary outcome: Symptom Severity Assessment at 2 Hours

Time frame: 2 hours. Least squares mean (Standard Error). Unit: Score on scale

Measure	Test Tablet n = 25	Placebo n = 27
Observed value	7.54 (0.596)	7.31 (0.587)
Change from baseline	-4.23 (0.596)	-4.46 (0.587)

Test Tablet vs Placebo: Mean Difference (Final Values): 0.23 (95% CI -1.32 to 1.78), p = 0.7662, ANCOVA

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs were collected from the start of the study until 5 days following last administration of the investigational product. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Tablet	0 of 25 (0%)	1 of 25 (4%)	Not reported
Placebo	0 of 27 (0%)	3 of 27 (11.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Test tablet in people with Common Cold, run by GlaxoSmithKline at 2 sites in China.

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 5 inclusion and 9 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: finished, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Symptom Severity Assessment at 15 Minutes (time frame: 15 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02246166.

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 14 Sep 2016.