AnalgesiaPhase 1NCT01568749
A Study Investigating the Pharmacokinetic Profiles of Four Extended Release Paracetamol Formulations
A Phase 1 study testing Paracetamol, Paracetamol formulation 1 and Paracetamol Formulation 2 in people with Analgesia, run by GlaxoSmithKline at 1 site in United States.
Trial summary
A study investigating the pharmacokinetic profiles of four extended release paracetamol formulations Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Paracetamol, Paracetamol formulation 1 and Paracetamol Formulation 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Age:Aged 18 to 50 years inclusive.
- Body Mass Index (BMI):Body Mass Index must be in the range 19 - 28 kg/m2.
- Compliance:Understands and is willing, able and likely to comply with all study procedures and restrictions.
- General Health:Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
- Contraception:Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.
Who cannot join
- Pregnancy:Women who are pregnant or who have a positive serum pregnancy test.
- Breast-feeding:Women who are breast-feeding.
- Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Clinical Study/Experimental Medication:a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. b) Previous participation in this study.
- Substance abuse:Recent history (within the last 5 years) of alcohol or other substance abuse.
- Personnel:An employee of the sponsor or the study site or members of their immediate family.
Show all 12Show fewer
- Disease: a) Current or recurrent disease that could affect the action, absorption or disposition of the study medication or clinical or laboratory assessments (e.g. hepatic disorders, renal insufficiency, congestive heart failure). b) Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
- Vegetarians:Subjects who are vegetarian.
- Hepatitis and HIV Screening:Positive screening for Serum Hepatitis B Surface Antigen, Hepatitis C or Human Immunodeficiency Virus (HIV).
- Medications:Current (within 14 days of screening) or regular use of any prescription, OTC, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing, (e.g. barbiturates, theophylline, cimetidine, or erythromycin).
- Smoking:Non-smokers of less than 3 months or current use of nicotine-containing products.
- Blood:Subject has donated or experienced significant blood loss within 56 days of Visit 2, donated plasma within 7 days of Visit 2, or has a hemoglobin value of = 12.0 g/dL.
Trial locations and contacts
1 site in 1 country.
About this study
A study investigating the pharmacokinetic profiles of four extended release paracetamol formulations
- Conditions
- Analgesia
- Being tested
- Paracetamol, Paracetamol formulation 1, Paracetamol Formulation 2, Paracetamol formulation 3, Paracetamol formulation 4
- Keywords
- otc, Analgesia, Paracetamol
- Medical subject headings
- Agnosia, Ornithine Carbamoyltransferase Deficiency Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Paracetamol
Paracetamol formulation 1Drug
Paracetamol
Paracetamol Formulation 2Drug
Paracetamol
Paracetamol formulation 3Drug
Paracetamol
Paracetamol formulation 4Drug
paracetamol
| Study group | Role | What they receive |
|---|---|---|
| Standard paracetamol | Active comparator | Marketed formulation Receives: Drug: Paracetamol |
| Formulation 1 | Experimental | Paracetamol formulation 1 Receives: Drug: Paracetamol formulation 1 |
| Formulation 2 | Experimental | Paracetamol formulation 2 Receives: Drug: Paracetamol Formulation 2 |
| Formulation 3 | Experimental | Paracetamol formulation 3 Receives: Drug: Paracetamol formulation 3 |
| Formulation 4 | Experimental | Paracetamol formulation 4 Receives: Drug: Paracetamol formulation 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive.
Measured: Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive.
Secondary outcomes (1)
Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive.
Measured: Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startDec 2008
- 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 AnalgesiaStudies 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
- 14 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
- NCT01568749
- Sponsor's protocol ID
- A2750596
- Status last verified
- Jun 2014
- First submitted
- 23 Jun 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 Study Investigating the Pharmacokinetic Profiles of Four Extended Release Paracetamol Formulations
- ClinicalTrials.gov ID
- NCT01568749
- Acronym / sponsor ID
- A2750596
- Conditions
- Analgesia
- Keywords
- otc, Analgesia, Paracetamol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 2 Apr 2012 (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.
A study investigating the pharmacokinetic profiles of four extended release paracetamol formulations
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Standard paracetamol | Active comparator | Drug: ParacetamolMarketed formulation |
| Formulation 1 | Experimental | Drug: Paracetamol formulation 1Paracetamol formulation 1 |
| Formulation 2 | Experimental | Drug: Paracetamol Formulation 2Paracetamol formulation 2 |
| Formulation 3 | Experimental | Drug: Paracetamol formulation 3Paracetamol formulation 3 |
| Formulation 4 | Experimental | Drug: Paracetamol formulation 4Paracetamol formulation 4 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Age:Aged 18 to 50 years inclusive.
- Body Mass Index (BMI):Body Mass Index must be in the range 19 - 28 kg/m2.
- Compliance:Understands and is willing, able and likely to comply with all study procedures and restrictions.
- General Health:Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
Key exclusion criteria (12 listed)
- Pregnancy:Women who are pregnant or who have a positive serum pregnancy test.
- Breast-feeding:Women who are breast-feeding.
- Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Clinical Study/Experimental Medication:a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. b) Previous participation in this study.
- Substance abuse:Recent history (within the last 5 years) of alcohol or other substance abuse.
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 |
|---|---|---|
| ParacetamolParacetamol | Drug | Standard paracetamol |
| Paracetamol formulation 1Paracetamol | Drug | Formulation 1 |
| Paracetamol Formulation 2Paracetamol | Drug | Formulation 2 |
| Paracetamol formulation 3Paracetamol | Drug | Formulation 3 |
| Paracetamol formulation 4paracetamol | Drug | Formulation 4 |
Primary outcome
Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive.
Time frame: Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive.
1 secondary outcome
Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive.
Time frame: Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive.
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 Paracetamol, Paracetamol formulation 1 and Paracetamol Formulation 2 in people with Analgesia, 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 6 inclusion and 12 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?
Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive. (time frame: Disclosure of this information is being delayed to protect business sensitive information. It will be disclosed when it is not longer business sensitive.). 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.