MOR and COMT SNP Polymorphism and Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by East Tallinn Central Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
East Tallinn Central Hospital
ClinicalTrials.gov Identifier:
NCT00773760
First received: October 15, 2008
Last updated: August 4, 2009
Last verified: August 2009
  Purpose

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


Condition Intervention
Pain Relief
Other: SNP genotyping

Study Type: Observational
Study Design: 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

Further study details as provided by East Tallinn Central Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • No secondary outcome endpoint [ Time Frame: no time frame ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood


Estimated Enrollment: 100
Study Start Date: October 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with prostate cancer

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00773760

Locations
Estonia
Yuri Kolesnikov MD PhD Recruiting
Tallinn, Estonia, 11312
Contact: Peeter Ross, MD    372 6973002    peeter.ross@itk.ee   
Contact: Yuri Kolesnikov    372 6973002    yuri.kolesnikov@itk.ee   
Sub-Investigator: Boris Gabovits, MD         
Principal Investigator: Yuri Kolesnikov, MD PhD         
Sponsors and Collaborators
East Tallinn Central Hospital
Investigators
Study Director: Yuri Kolesnikov, MD PhD ETCH
  More Information

Additional Information:
No publications provided

Responsible Party: A.Veske PhD Director of Department of Gene Technology, TTU
ClinicalTrials.gov Identifier: NCT00773760     History of Changes
Other Study ID Numbers: ITK-1
Study First Received: October 15, 2008
Last Updated: August 4, 2009
Health Authority: Estonia: National Institute for Health Development

Keywords provided by East Tallinn Central Hospital:
opioids
COMT
SNP
analgesia
postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014