MOR and COMT SNP Polymorphism and Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00773760
Recruitment Status : Unknown
Verified August 2009 by East Tallinn Central Hospital.
Recruitment status was:  Recruiting
First Posted : October 16, 2008
Last Update Posted : August 6, 2009
Information provided by:
East Tallinn Central Hospital

Brief Summary:
Patients with certain polymorphism in the MOR and COMT genes will display differences in their response to analgesics.

Condition or disease Intervention/treatment
Pain Relief Other: SNP genotyping

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
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does mu Opioid Receptor (MOR) and Catechol-O-methyltransferase (COMT) Genes Polymorphism Correlate of Clinical Postoperative Pain and Response to Analgesics
Study Start Date : October 2008
Estimated Primary Completion Date : October 2009
Estimated Study Completion Date : December 2009

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U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. No secondary outcome endpoint [ Time Frame: no time frame ]

Biospecimen Retention:   Samples With DNA

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with prostate cancer

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00773760

Yuri Kolesnikov MD PhD Recruiting
Tallinn, Estonia, 11312
Contact: Peeter Ross, MD    372 6973002   
Contact: Yuri Kolesnikov    372 6973002   
Sub-Investigator: Boris Gabovits, MD         
Principal Investigator: Yuri Kolesnikov, MD PhD         
Sponsors and Collaborators
East Tallinn Central Hospital
Study Director: Yuri Kolesnikov, MD PhD ETCH

Additional Information:
Responsible Party: A.Veske PhD Director of Department of Gene Technology, TTU Identifier: NCT00773760     History of Changes
Other Study ID Numbers: ITK-1
First Posted: October 16, 2008    Key Record Dates
Last Update Posted: August 6, 2009
Last Verified: August 2009

Keywords provided by East Tallinn Central Hospital:
postoperative pain