PainPhase 1NCT00802308
Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Moderate Drinkers
A Phase 1 study testing Morphine sulphate in people with Pain, run by Egalet Ltd.
Trial summary
The purpose of the study is to evaluate the pharmacokinetics of Egalet® morphine when administered with alcohol and compare to administration with water. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Morphine sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Feb 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Main Inclusion Criteria:
- Body mass index (BMI) within the range of 20 to 33 kg/m2 and a minimum weight of at least 50 kg.
- Current alcohol users who are classified as moderate drinkers
- Able to abstain from alcohol during the 48 hour period preceding each study visit
- Free from any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-Lead ECG, and laboratory evaluation
Main Exclusion Criteria:
- Intolerance towards alcohol
- History of allergy or hypersensitivity to opioids or related drugs or any excipients
- Any history of drug or alcohol dependence
- Clinically significant abnormalities on physical examination, medical history, 12-Lead ECG, vital signs, or laboratory values
- Gastrointestinal disease or constipation or other clinically significant gastrointestinal problems
About this study
Official title: A Randomized, Partially Blind, Four-way Crossover Study to Determine the Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Male and Female Moderate Drinkers
The purpose of the study is to evaluate the pharmacokinetics of Egalet® morphine when administered with alcohol and compare to administration with water.
Read the detailed description
Outcome: Pharmacokinetic parameters
- Conditions
- Pain
- Being tested
- Morphine sulphate
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine sulphateDrug
Extended release tablet combined with alcohol or water
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Single dose administration of Egalet® morphine with alcohol Receives: Drug: Morphine sulphate |
| Treatment B | Experimental | Single dose administration of Egalet® morphine with alcohol Receives: Drug: Morphine sulphate |
| Treatment C | Experimental | Single dose administration of Egalet® morphine with alcohol Receives: Drug: Morphine sulphate |
| Treatment D | Placebo comparator | Single dose administration of Egalet® morphine with water Receives: Drug: Morphine sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate pharmacokinetic effects of the co-administration of alcohol and Egalet® morphine. AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el, and Kel.
Measured: Single-dose evaluation
Secondary outcomes (1)
To evaluate the safety and tolerability of the co-administration of alcohol and Egalet® morphine. Hematology, biochemistry, urinalysis, ECG, vital signs, physical examination, and adverse events monitoring
Measured: Single-dose evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egalet Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine Andersen, M.Sc., Study director, Egalet A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802308
- Sponsor's protocol ID
- MP-EG-010
- Status last verified
- Sep 2016
- First submitted
- 2 Dec 2008
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
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 Randomized, Partially Blind, Four-way Crossover Study to Determine the Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Male and Female Moderate Drinkers
- ClinicalTrials.gov ID
- NCT00802308
- Acronym / sponsor ID
- MP-EG-010
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Egalet LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 4 Dec 2008 (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 the study is to evaluate the pharmacokinetics of Egalet® morphine when administered with alcohol and compare to administration with water.
Detailed description
Outcome: Pharmacokinetic parameters
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Morphine sulphateSingle dose administration of Egalet® morphine with alcohol |
| Treatment B | Experimental | Drug: Morphine sulphateSingle dose administration of Egalet® morphine with alcohol |
| Treatment C | Experimental | Drug: Morphine sulphateSingle dose administration of Egalet® morphine with alcohol |
| Treatment D | Placebo comparator | Drug: Morphine sulphateSingle dose administration of Egalet® morphine with water |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 |
|---|---|---|
| Morphine sulphateExtended release tablet combined with alcohol or water | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
Primary outcome
To evaluate pharmacokinetic effects of the co-administration of alcohol and Egalet® morphine. AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el, and Kel.
Time frame: Single-dose evaluation
1 secondary outcome
To evaluate the safety and tolerability of the co-administration of alcohol and Egalet® morphine. Hematology, biochemistry, urinalysis, ECG, vital signs, physical examination, and adverse events monitoring
Time frame: Single-dose evaluation
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 14 Sep 2016.
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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.
Christine Andersen, M.Sc. study director
Egalet A/S
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Morphine sulphate in people with Pain, run by Egalet Ltd.
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 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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?
To evaluate pharmacokinetic effects of the co-administration of alcohol and Egalet® morphine. AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el, and Kel. (time frame: Single-dose evaluation). 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 14 Sep 2016.