MOR and COMT SNP Polymorphism and Pain - Full Text View

Sponsored by:	East Tallinn Central Hospital
Information provided by:	East Tallinn Central Hospital
ClinicalTrials.gov Identifier:	NCT00773760

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

Drug Information available for: Interferon alfa-2b

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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

Biospecimen Description:

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.

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.

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

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
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

East Tallinn Central Hospital This link exits the ClinicalTrials.gov site

Responsible Party:	TTU ( A.Veske PhD Director of Department of Gene Technology )
Study ID Numbers:	ITK-1
Study First Received:	October 15, 2008
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00773760
Health Authority:	Estonia: National Institute for Health Development

Keywords provided by East Tallinn Central Hospital:

opioids
COMT
SNP
analgesia
postoperative pain

Study placed in the following topic categories:

Pain
Interferon Alfa-2b
Pain, Postoperative

ClinicalTrials.gov processed this record on January 14, 2009