Headache, Tension-TypePhase 1NCT01476176
A Pharmacokinetic Study of an Experimental Paracetamol Formulation
A Phase 1 study testing Experimental paracetamol and Paracetamol marketed formulation in people with Headache, Tension-Type, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This PK study is designed to show bioequivalence between the study treatments. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache, Tension-Type
- What is being tested?
- Experimental paracetamol and Paracetamol marketed formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Aug 2009
- Phase
- Phase 1
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteer
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pivotal Pharmacokinetic Study Investigating the Extent of Absorptions of Paracetamol and Caffeine for Two Different Paracetomol Formulations Containing Caffeine
This PK study is designed to show bioequivalence between the study treatments.
- Conditions
- Headache, Tension-Type
- Being tested
- Experimental paracetamol, Paracetamol marketed formulation
- Keywords
- Bioequivalence, Pharmacokinetics, Healthy volunteers, paracetamol, caffeine
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental paracetamolDrug
experimental paracetamol with caffeine
Paracetamol marketed formulationDrug
marketed formulation containing caffeine
| Study group | Role | What they receive |
|---|---|---|
| Experimental paracetamol formulation | Experimental | experimental formulation Receives: Drug: Experimental paracetamol |
| paracetamol marketed formulation | Active comparator | Paracetamol marketed formulation Receives: Drug: Paracetamol marketed formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence
Measured: 10 hours
Secondary outcomes (1)
PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax)
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJul 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache, Tension-TypeStudies 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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
- NCT01476176
- Sponsor's protocol ID
- A2260665
- Status last verified
- Jun 2014
- First submitted
- 17 Nov 2011
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Pharmacokinetic Study Investigating the Extent of Absorptions of Paracetamol and Caffeine for Two Different Paracetomol Formulations Containing Caffeine
- ClinicalTrials.gov ID
- NCT01476176
- Acronym / sponsor ID
- A2260665
- Conditions
- Headache, Tension-Type
- Keywords
- Bioequivalence, Pharmacokinetics, Healthy volunteers, paracetamol, caffeine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 22 Nov 2011 (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.
This PK study is designed to show bioequivalence between the study treatments.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental paracetamol formulation | Experimental | Drug: Experimental paracetamolexperimental formulation |
| paracetamol marketed formulation | Active comparator | Drug: Paracetamol marketed formulationParacetamol marketed formulation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteer
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Experimental paracetamolexperimental paracetamol with caffeine | Drug | Experimental paracetamol formulation |
| Paracetamol marketed formulationmarketed formulation containing caffeine | Drug | paracetamol marketed formulation |
Primary outcome
PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence
Time frame: 10 hours
1 secondary outcome
PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax)
Time frame: 10 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
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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 1 study testing Experimental paracetamol and Paracetamol marketed formulation in people with Headache, Tension-Type, run by GlaxoSmithKline at 1 site in United States.
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 1 inclusion and 1 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 24 Nov 2014. 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 States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence (time frame: 10 hours). 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 24 Nov 2014.