Pain ReliefNCT00773760
MOR and COMT SNP Polymorphism and Pain
An observational study of Pain Relief, run by East Tallinn Central Hospital at 1 site in Estonia.
Trial summary
Patients with certain polymorphism in the MOR and COMT genes will display differences in their response to analgesics. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain Relief
- What is being tested?
- SNP genotyping
- How many people
- 100 participants
- Where
- 1 siteEstonia
- Study dates
- Oct 2008to Dec 2009
- Phase
- Observational
- 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
Study population: patients with prostate cancer
Who may be able to join
- 18 years of age and older
- Give informed consent to participate in this study
Who cannot join
- Neurologic or psychiatric disease sufficient, in the clinical judgment of the investigator, to compromise informed consent or data collection
- ASA classification score 3 or above
- Patients with past or present history of substance abuse.
- Patients with a history of chronic pain requiring daily analgesic use for more then one month.
- Patients with a current diagnosis of anxiety or depression requiring medical treatment
- Patients allergic to morphine
Trial locations and contacts
1 site in 1 country.
Estonia1 site, 1 recruiting
- Recruiting
Yuri Kolesnikov MD PhD
Tallinn, 11312
Peeter Ross, MD, 372 6973002, peeter.ross@itk.ee
Yuri Kolesnikov, 372 6973002, yuri.kolesnikov@itk.ee
About this study
Official title: Does mu Opioid Receptor (MOR) and Catechol-O-methyltransferase (COMT) Genes Polymorphism Correlate of Clinical Postoperative Pain and Response to Analgesics
Patients with certain polymorphism in the MOR and COMT genes will display differences in their response to analgesics.
Read the detailed description
After tissue injury, there is great interindividual variability among patients in the amount of pain experienced (pain intensity and duration of pain) and in the degree of pain relief from analgesics. In experimental settings, Single Nucleotide Polymorphisms (SNP) at the MOR and COMT genes have been found to alter the response to opioids in in vitro models and in human.We will collect clinical data on one hundred patients undergoing surgery. We will obtain DNA extracted via PCR techniques from the patients' blood and we will identify SNPs at the mu opioid receptor and catechol-O-methyltransferase genes. We will analyze the data to search for correlation between clinical patterns of postoperative pain and opioid effects and SNPs.
- Conditions
- Pain Relief
- Being tested
- SNP genotyping
- Keywords
- opioids, COMT, SNP, analgesia, postoperative pain
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNP genotypingOther
Coded blood specimens will be transported to the Department of Gene Technology TTÜ and genotyping analysis will be performed. Lymphocytes will be isolated from blood specimens using Ficol-Paq gradients, and genomic DNA isolated using a salting-out procedure. Variants of the MOR gene and other genes of interests will be performed by DNA sequence analysis of PCR-amplified DNA, using primers located in flanking intron sequence. All methods proposed are currently in operation in the respective facilities.
| Study group | Role | What they receive |
|---|---|---|
| dosing | Not described Receives: Other: SNP genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative assessments include PCA use (e.g., number of patient demands, total morphine administered) in each 24-h interval during the 48-h study period - primary endpoint.
Measured: 48 hours
Secondary outcomes (1)
No secondary outcome endpoint
Measured: no time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionOct 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ReliefStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Tallinn Central Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yuri Kolesnikov, MD PhD, Study director, ETCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773760
- Sponsor's protocol ID
- ITK-1
- Status last verified
- Aug 2009
- First submitted
- 15 Oct 2008
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does mu Opioid Receptor (MOR) and Catechol-O-methyltransferase (COMT) Genes Polymorphism Correlate of Clinical Postoperative Pain and Response to Analgesics
- ClinicalTrials.gov ID
- NCT00773760
- Acronym / sponsor ID
- ITK-1
- Conditions
- Pain Relief
- Keywords
- opioids, COMT, SNP, analgesia, postoperative pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- East Tallinn Central HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 16 Oct 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.
Patients with certain polymorphism in the MOR and COMT genes will display differences in their response to analgesics.
Detailed description
After tissue injury, there is great interindividual variability among patients in the amount of pain experienced (pain intensity and duration of pain) and in the degree of pain relief from analgesics. In experimental settings, Single Nucleotide Polymorphisms (SNP) at the MOR and COMT genes have been found to alter the response to opioids in in vitro models and in human.We will collect clinical data on one hundred patients undergoing surgery. We will obtain DNA extracted via PCR techniques from the patients' blood and we will identify SNPs at the mu opioid receptor and catechol-O-methyltransferase genes. We will analyze the data to search for correlation between clinical patterns of postoperative pain and opioid effects and SNPs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dosing | – | Other: SNP genotyping |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with prostate cancer
Key inclusion criteria (2 listed)
- 18 years of age and older
- Give informed consent to participate in this study
Key exclusion criteria (6 listed)
- Neurologic or psychiatric disease sufficient, in the clinical judgment of the investigator, to compromise informed consent or data collection
- ASA classification score 3 or above
- Patients with past or present history of substance abuse.
- Patients with a history of chronic pain requiring daily analgesic use for more then one month.
- Patients with a current diagnosis of anxiety or depression requiring medical treatment
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 |
|---|---|---|
| SNP genotypingCoded blood specimens will be transported to the Department of Gene Technology TTÜ and genotyping analysis will be performed. Lymphocytes will be isolated from blood specimens using Ficol-Paq gradients, and genomic DNA isolated using a salting-out procedure. Variants of the MOR gene and other genes of interests will be performed by DNA sequence analysis of PCR-amplified DNA, using primers located in flanking intron sequence. All methods proposed are currently in operation in the respective facilities. | Other | dosing |
Primary outcome
Postoperative assessments include PCA use (e.g., number of patient demands, total morphine administered) in each 24-h interval during the 48-h study period - primary endpoint.
Time frame: 48 hours
1 secondary outcome
No secondary outcome endpoint
Time frame: no time frame
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
- East Tallinn Central HospitalLink provided by the sponsor.
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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.
Yuri Kolesnikov, MD PhD study director
ETCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Relief, run by East Tallinn Central Hospital at 1 site in Estonia.
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 2 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: status not confirmed, as of the sponsor's last update on 6 Aug 2009. 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 Estonia. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative assessments include PCA use (e.g., number of patient demands, total morphine administered) in each 24-h interval during the 48-h study period - primary endpoint. (time frame: 48 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 6 Aug 2009.