MOR and COMT SNP Polymorphism and Pain

August 4, 2009 updated by: East Tallinn Central Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tallinn, Estonia, 11312
        • Recruiting
        • Yuri Kolesnikov MD PhD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Boris Gabovits, MD
        • Principal Investigator:
          • Yuri Kolesnikov, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with prostate cancer

Description

Inclusion Criteria:

  • 18 years of age and older
  • Give informed consent to participate in this study

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
dosing
Other: SNP genotyping
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
No secondary outcome endpoint
Time Frame: no time frame
no time frame

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Tallinn Central Hospital

Investigators

  • Study Director: Yuri Kolesnikov, MD PhD, ETCH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Anticipated)

October 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

October 15, 2008

First Submitted That Met QC Criteria

October 15, 2008

First Posted (Estimate)

October 16, 2008

Study Record Updates

Last Update Posted (Estimate)

August 6, 2009

Last Update Submitted That Met QC Criteria

August 4, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ITK-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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