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Study of Medication Compliance - a Comparison of Patients in Pain Management and Pre-surgical Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01625065
First Posted: June 21, 2012
Last Update Posted: June 21, 2012
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.
Information provided by (Responsible Party):
Christoph Maier, Ruhr University of Bochum
  Purpose
In this study medication compliance regarding current drug use is investigated using toxicological analyzes in two patient groups: patients from a pain management department and pre-surgical control patients. The aim is to explore the incidence of concealed and feigned substances and to determine the respective substance classes. Expecting that noncompliance is higher in the pain patient group, the investigators want to identify clinical risk factors for noncompliant drug report.

Condition
Pain

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Toxicological Analyses of Blood and Urine Samples in Pain Patients and Pre-surgical Control Patients to Investigate Incidences of Concealed and Feigned Substances

Further study details as provided by Christoph Maier, Ruhr University of Bochum:

Biospecimen Description:
serum, urine

Enrollment: 343
Study Start Date: May 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
pain patients
patients from a specific pain management department, patients with long duration of pain, mostly insufficiently treated pain
pre-surgical patients
patients from a surgical outpatient department with current pain

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pain management and surgical outpatient department of a University hospital
Criteria

Inclusion Criteria:

  • provided informed consent
  • current pain

Exclusion Criteria:

  • no taking of blood sample possible
  • no consent with toxicological analyzes
  • insufficient comprehension of the German language
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01625065


Locations
Germany
University hospital Bergmannsheil
Bochum, Germany
Sponsors and Collaborators
Ruhr University of Bochum
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christoph Maier, Prof. Dr. med., Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT01625065     History of Changes
Other Study ID Numbers: Medi-3889-10
First Submitted: June 19, 2012
First Posted: June 21, 2012
Last Update Posted: June 21, 2012
Last Verified: June 2012

Keywords provided by Christoph Maier, Ruhr University of Bochum:
medication compliance
adherence
toxicological analyzes
GC-MS
HPLC
pain patients
opioid misuse
patients with current pain