MOR and COMT SNP Polymorphism and Pain

NCT00773760 | Unknown DMC

• 1 other identifier: ITK-1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain Relief

Keywords

opioids; COMT; SNP; analgesia; postoperative pain

Outcome Measures

Primary Outcomes (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.

  48 hours

Secondary Outcomes (1)

• No secondary outcome endpoint

  no time frame

Study Arms (1)

dosing

Other: SNP genotyping

Interventions

SNP genotyping OTHER

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.

dosing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with prostate cancer

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• East Tallinn Central Hospital: lead

Study Sites (1)

Yuri Kolesnikov MD PhD

Tallinn, 11312, Estonia

RECRUITING

Related Links

• East Tallinn Central Hospital

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Yuri Kolesnikov, MD PhD

  ETCH

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 6, 2009

Record last verified: 2009-08

Locations

ES (1)