InfluenzaPhase 4NCT01332578

A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies

A Phase 4 study testing Paracetamol, Phenylephrine and Ascorbic Acid in people with Influenza and Common Cold, run by GlaxoSmithKline at 1 site in United Kingdom.

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 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Influenza, Common Cold
What is being tested?: Paracetamol, Phenylephrine and Ascorbic Acid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteUnited Kingdom
Study dates: May 2011to Jun 2011
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 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Healthy male volunteers
Body mass index between 18.0-29.9 kg/m^2

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

BIO-IMAGES Research Ltd.
Glasgow, Scotland, G63 0BX

Other trials in United Kingdom

About this study

The study is designed to investigate whether paracetamol from a hot remedy reaches the plasma faster than standard paracetamol tablets. The study will also assess the gastrointestinal transit of two oral cold and influenza ('flu') formulations using gamma scintigraphy. It is postulated that paracetamol in solution, such as from cold and 'flu' hot remedies, provides a greater early exposure compared to standard paracetamol tablets. In addition, the pharmacokinetic (PK) profile of paracetamol in the two formulations will be investigated.

Conditions: Influenza, Common Cold
Being tested: Paracetamol, Phenylephrine, Ascorbic Acid
Medical subject headings: Influenza, Human, Common Cold

What participants receive

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

ParacetamolDrug
Present in both test and active comparator
PhenylephrineDrug
Test product
Ascorbic AcidDrug
Test product

Study groups in NCT01332578
Study group	Role	What they receive
Test Product	Experimental	Paracetamol, phenylephrine and ascorbic acid to be administered in 150 milliliters (mL) of hot water. Receives: Drug: Paracetamol; Drug: Phenylephrine; Drug: Ascorbic Acid
Paracetamol tablet	Active comparator	Two paracetamol 500 mg tablets to be administered with 150 mL of hot water. Receives: Drug: Paracetamol

What is being measured

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

Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter)
Time to reach plasma paracetamol concentration of 0.25 μg/mL was determined using plasma concentration time profiles.
Measured: Blood samples taken within 15-30 minutes prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose

Secondary outcomes (7)

Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min)
AUC (0-30 min) was determined from paracetamol plasma concentration time profiles using trapezoidal rule.
Measured: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose
AUC (0-60 Min)
AUC (0-60 min) was determined from paracetamol plasma concentration time profiles using trapezoidal method.
Measured: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose
Maximum Plasma Concentration (Cmax)
Cmax was determined using plasma paracetamol concentration time profile.
Measured: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose
Time to Maximum Plasma Concentration (Tmax)
Time after administration when the maximum plasma concentration was reached.
Measured: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose
Time to Onset of Gastric Emptying
The individual anterior and posterior images were assessed using Gamma Scintigraphy images and WebLink Image Analysis program to determine the time to onset of gastric emptying of hot drink remedy and standard paracetamol tablets.
Measured: Baseline to 10 hours
Time to Completion of Gastric Emptying
Time to completion of gastric emptying of hot drink remedy and standard paracetamol tablets was assessed using Gamma Scintigraphy images and WebLink image analysis program. Completion of gastric emptying was confirmed by two consecutive images with negligible gastric activity.
Measured: Baseline to 10 hours
Time to Onset and Completion of Disintegration of Reference Tablets
Qualitative onset and completion of tablet disintegration was determined using Gamma scintigraphy images and WebLink image analysis program.
Measured: Baseline to 10 hours post dose

Timeline

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

May 2011Jun 2011

First posted11 Apr 2011 (estimated)
Study startMay 2011
Primary completionJun 2011
Study completionJun 2011

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 InfluenzaStudies 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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01332578
Sponsor's protocol ID: C7591227
Status last verified: Apr 2015
First submitted: 7 Apr 2011
Last updated: 1 Jun 2015
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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies
ClinicalTrials.gov ID: NCT01332578
Acronym / sponsor ID: C7591227
Conditions: Influenza, Common Cold
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 11 Apr 2011 (estimated)
Results: Posted 1 Jun 2015

Clinical summary

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

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test Product	Experimental	Drug: Paracetamol, Drug: Phenylephrine, Drug: Ascorbic AcidParacetamol, phenylephrine and ascorbic acid to be administered in 150 milliliters (mL) of hot water.
Paracetamol tablet	Active comparator	Drug: ParacetamolTwo paracetamol 500 mg tablets to be administered with 150 mL of hot water.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

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
ParacetamolPresent in both test and active comparator	Drug	Paracetamol tablet, Test Product
PhenylephrineTest product	Drug	Test Product
Ascorbic AcidTest product	Drug	Test Product

Primary outcome

Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter)
Time frame: Blood samples taken within 15-30 minutes prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose
Time to reach plasma paracetamol concentration of 0.25 μg/mL was determined using plasma concentration time profiles.

7 secondary outcomes

Area Under the Concentration/Time Curve From 0 to 30 Minutes (Min) (AUC 0-30 Min)
Time frame: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose
AUC (0-60 Min)
Time frame: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose
Maximum Plasma Concentration (Cmax)
Time frame: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose
Time to Maximum Plasma Concentration (Tmax)
Time frame: Blood samples taken within 15-30 min prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose
Time to Onset of Gastric Emptying
Time frame: Baseline to 10 hours
Time to Completion of Gastric Emptying
Time frame: Baseline to 10 hours
Time to Onset and Completion of Disintegration of Reference Tablets
Time frame: Baseline to 10 hours post dose

Results and safety

Results posted to the registry on 1 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hot Drink Remedy First, Then Standard Paracetamol Tablets	12	12
Standard Paracetamol Tablets First, Then Hot Drink Remedy	13	13

Primary outcome: Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter)

Time frame: Blood samples taken within 15-30 minutes prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose. Median (Full Range). Unit: minutes

Measure	Hot Drink Remedy n = 24	Standard Paracetamol Tablets n = 25
Value	4.59 (3.4 to 11.1)	23.14 (6.0 to 46.6)

Hot Drink Remedy vs Standard Paracetamol Tablets: Median Difference (Final Values): -20.92 (95% CI -27.31 to -15.81), p = 0.0004, Wilcoxon (Mann-Whitney)

Population analysed: Modified Intent-To-Treat (MITT) population: all randomized participants with any post baseline pharmacokinetic measurement or scintigraphic measurement, and had evaluable data in at least one of the two study periods.

7 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Hot Drink Remedy	0 of 25 (0%)	3 of 25 (12%)	Not reported
Standard Paracetamol Tablets	0 of 25 (0%)	3 of 25 (12%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Paracetamol, Phenylephrine and Ascorbic Acid in people with Influenza and Common Cold, run by GlaxoSmithKline at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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. 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 1 Jun 2015). 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?

Time to Reach Plasma Paracetamol Concentration of 0.25 μg/mL (Microgram Per Milliliter) (time frame: Blood samples taken within 15-30 minutes prior to dosing and at 3, 5, 7, 9, 11, 15, 20, 30, 45, 90, 120 and 180 minutes post-dose). 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 NCT01332578.

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 1 Jun 2015.