- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01052155
Accuracy of Point of Care (POC) or In-office Urine Drug Testing (Immunoassay) in Chronic Pain Patients
March 11, 2011 updated by: Pain Management Center of Paducah
Accuracy of Point of Care (POC) or In-office Urine Drug Testing (Immunoassay) in Chronic Pain Patients: A Prospective Analysis of Immunoassay and Liquid Chromatography Tandem Mass Spectometry (LC/MS/MS)
Accuracy of Point of Care (POC) or In-office Urine Drug Testing (Immunoassay) in Chronic Pain Patients: A Prospective Analysis of Immunoassay and Liquid Chromatography Tandem Mass Spectometry (LC/MS/MS)
Study Overview
Detailed Description
Recruitment is indicated in patients with chronic pain management with or without controlled substance therapy.
This is a diagnostic accuracy study performed in an interventional pain management referral center in the United States.
Study Type
Observational
Enrollment (Anticipated)
1000
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with chronic pain management with or without controlled substance therapy.
Description
Inclusion criteria:
• Chronic pain management with or without controlled substance therapy.
Exclusion criteria:
None
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diagnostic accuracy
Time Frame: 72 hours
|
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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.
General Publications
- Manchikanti L, Malla Y, Wargo BW, Fellows B. Comparative evaluation of the accuracy of benzodiazepine testing in chronic pain patients utilizing immunoassay with liquid chromatography tandem mass spectrometry (LC/MS/MS) of urine drug testing. Pain Physician. 2011 May-Jun;14(3):259-70.
- Manchikanti L, Malla Y, Wargo BW, Fellows B. Comparative evaluation of the accuracy of immunoassay with liquid chromatography tandem mass spectrometry (LC/MS/MS) of urine drug testing (UDT) opioids and illicit drugs in chronic pain patients. Pain Physician. 2011 Mar-Apr;14(2):175-87.
- Manchikanti L, Malla Y, Wargo BW, Cash KA, Pampati V, Damron KS, McManus CD, Brandon DE. Protocol for accuracy of point of care (POC) or in-office urine drug testing (immunoassay) in chronic pain patients: a prospective analysis of immunoassay and liquid chromatography tandem mass spectometry (LC/MS/MS). Pain Physician. 2010 Jan-Feb;13(1):E1-E22.
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
February 1, 2010
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
January 18, 2010
First Submitted That Met QC Criteria
January 18, 2010
First Posted (Estimate)
January 20, 2010
Study Record Updates
Last Update Posted (Estimate)
March 14, 2011
Last Update Submitted That Met QC Criteria
March 11, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocol 26
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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