Drug InteractionsPhase 1NCT00429468
A Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers
A Phase 1 study testing Vicodin® CR (extended-release hydrocodone/acetaminophen) in people with Drug Interactions, run by Abbott at 1 site in Canada.
Trial summary
The purpose of this research study is to determine if varying strengths of ethanol affect the drug level and safety profile of Vicodin® CR. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interactions
- What is being tested?
- Vicodin® CR (extended-release hydrocodone/acetaminophen)
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2007to not given
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females ages 19 to 55
- If female, must be of non-child bearing potential or practicing birth control
- Current alcohol users who are classified as moderate drinkers (defined as 7-21 drinks per week)
Who cannot join
- Intolerance towards ethanol
- Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
- Significant GI narrowing or abnormality with a potential to inhibit GI motility or tablet transport
- History of seizures or convulsions, head injury or other intracranial lesions, or a pre-existing increase in intracranial pressure
- Has any clinically significant abnormalities on physical examination, ECG, or laboratory values
- Treatment with any investigational drug within 30 days of administration of study drug in the Treatment Phase
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Centre, Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers
The purpose of this research study is to determine if varying strengths of ethanol affect the drug level and safety profile of Vicodin® CR.
- Conditions
- Drug Interactions
- Being tested
- Vicodin® CR (extended-release hydrocodone/acetaminophen)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vicodin® CR (extended-release hydrocodone/acetaminophen)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard pharmacokinetic assessments
statistical, clinical and laboratory procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionsStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rita Jain, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429468
- Sponsor's protocol ID
- M06-835
- Status last verified
- Oct 2007
- First submitted
- 29 Jan 2007
- Last updated
- 26 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre, Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers
- ClinicalTrials.gov ID
- NCT00429468
- Acronym / sponsor ID
- M06-835
- Conditions
- Drug Interactions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- First posted
- 31 Jan 2007 (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 this research study is to determine if varying strengths of ethanol affect the drug level and safety profile of Vicodin® CR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and females ages 19 to 55
- If female, must be of non-child bearing potential or practicing birth control
- Current alcohol users who are classified as moderate drinkers (defined as 7-21 drinks per week)
Key exclusion criteria (6 listed)
- Intolerance towards ethanol
- Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
- Significant GI narrowing or abnormality with a potential to inhibit GI motility or tablet transport
- History of seizures or convulsions, head injury or other intracranial lesions, or a pre-existing increase in intracranial pressure
- Has any clinically significant abnormalities on physical examination, ECG, or laboratory values
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 |
|---|---|---|
| Vicodin® CR (extended-release hydrocodone/acetaminophen) | Drug | – |
Primary outcome
Standard pharmacokinetic assessments
statistical, clinical and laboratory procedures
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 26 Oct 2007.
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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.
Rita Jain, MD study director
Abbott
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 Vicodin® CR (extended-release hydrocodone/acetaminophen) in people with Drug Interactions, run by Abbott at 1 site in Canada.
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 3 inclusion and 6 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 26 Oct 2007. 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 Canada. 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?
Standard pharmacokinetic assessments. The study lists 2 primary outcomes in all. 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 26 Oct 2007.