Sickle Cell DiseasePhase 1/2NCT00174538
Codeine in Sickle Cell Disease
A Phase 1/2 study testing Codeine (30 mg) in people with Sickle Cell Disease, run by PriCara, Unit of Ortho-McNeil, Inc. at 1 site in United States.
Trial summary
The objective of this study is to determine if a subject's genetic make-up would affect the treatment response to codeine in subjects with sickle cell disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Codeine (30 mg)
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Dec 2005
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years old
- Sickle cell disease (HbSS)
- Hydrocodone- or codeine-containing medications to manage an acute pain crisis in the past
Who cannot join
- Renal dysfunction, serum creatinine (SCr) > 2.0 mg/dl
- Hepatic dysfunction, AST, ALT or direct bilirubin > 3 x upper limit of normal (ULN)
- Codeine allergy
- Medications shown to induce or inhibit CYP2D6
- Women who are pregnant or breast feeding
- Unable to provide written, informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Medical Center
Chicago, Illinois, 60612
About this study
Official title: The Effects of Cytochrome P450 2D6 Genotype on Pain Management With Codeine in Sickle Cell Disease
The objective of this study is to determine if a subject's genetic make-up would affect the treatment response to codeine in subjects with sickle cell disease.
Read the detailed description
People with sickle cell disease require oral pain medications to manage an acute pain crisis. Sometimes these individuals fail to obtain adequate pain relief with the medications prescribed for outpatient use resulting in emergency room visits and hospital admissions. Subsequently, many patients are admitted to the hospital for pain management for a few days until the pain crisis resolves. The most common medications prescribed to sickle cell individuals for outpatient use include codeine and hydrocodone containing medications (i.e. Tylenol #3™, Vicodin™, Lortab™). These medications must be broken down in the body to make the active pain reliever (morphine or hydromorphone, respectively). Some individuals may not be able to break down these medications to the active pain reliever; therefore, these individuals will likely continue to experience pain unless they take other pain medications. We will determine whether genotype estimates the ability of CYP2D6 to break down codeine to the active pain reliever in individuals with sickle cell disease.
- Conditions
- Sickle Cell Disease
- Being tested
- Codeine (30 mg)
- Keywords
- codeine, pain, CYP2D6, genotype, morphine, sickle cell, pharmacokinetic
- Medical subject headings
- Anemia, Sickle Cell, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Codeine (30 mg)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma morphine and codeine concentrations
CYP2D6 genotype
Secondary outcomes (2)
Disease severity
Hospitalizations and admissions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PriCara, Unit of Ortho-McNeil, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stacy S. Shord, PharmD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174538
- Sponsor's protocol ID
- CR007111
- Other IDs
- FEN-EMR-4007
- Status last verified
- Jul 2005
- First submitted
- 9 Sep 2005
- Last updated
- 30 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cytochrome P450 2D6 Genotype on Pain Management With Codeine in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT00174538
- Acronym / sponsor ID
- CR007111
- Conditions
- Sickle Cell Disease
- Keywords
- codeine, pain, CYP2D6, genotype, morphine, sickle cell, pharmacokinetic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- PriCara, Unit of Ortho-McNeil, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Dec 2005
- First posted
- 15 Sep 2005 (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 objective of this study is to determine if a subject's genetic make-up would affect the treatment response to codeine in subjects with sickle cell disease.
Detailed description
People with sickle cell disease require oral pain medications to manage an acute pain crisis. Sometimes these individuals fail to obtain adequate pain relief with the medications prescribed for outpatient use resulting in emergency room visits and hospital admissions. Subsequently, many patients are admitted to the hospital for pain management for a few days until the pain crisis resolves. The most common medications prescribed to sickle cell individuals for outpatient use include codeine and hydrocodone containing medications (i.e. Tylenol #3™, Vicodin™, Lortab™). These medications must be broken down in the body to make the active pain reliever (morphine or hydromorphone, respectively). Some individuals may not be able to break down these medications to the active pain reliever; therefore, these individuals will likely continue to experience pain unless they take other pain medications. We will determine whether genotype estimates the ability of CYP2D6 to break down codeine to the active pain reliever in individuals with sickle cell disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 18 years old
- Sickle cell disease (HbSS)
- Hydrocodone- or codeine-containing medications to manage an acute pain crisis in the past
Key exclusion criteria (6 listed)
- Renal dysfunction, serum creatinine (SCr) > 2.0 mg/dl
- Hepatic dysfunction, AST, ALT or direct bilirubin > 3 x upper limit of normal (ULN)
- Codeine allergy
- Medications shown to induce or inhibit CYP2D6
- Women who are pregnant or breast feeding
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 |
|---|---|---|
| Codeine (30 mg) | Drug | – |
Primary outcome
Plasma morphine and codeine concentrations
CYP2D6 genotype
2 secondary outcomes
Disease severity
Hospitalizations and admissions
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 30 Jun 2011.
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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.
Stacy S. Shord, PharmD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Codeine (30 mg) in people with Sickle Cell Disease, run by PriCara, Unit of Ortho-McNeil, Inc. 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 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 30 Jun 2011. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Plasma morphine and codeine concentrations. 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 30 Jun 2011.