Study of Medication Compliance - a Comparison of Patients... | NCT01625065

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

NCT01625065

Sponsor

Ruhr University of Bochum

Status

Completed

Last Update Posted

Jun 21, 2012Estimated

Enrollment

343Actual

Phase

Not provided

Conditions

Pain

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Jun 19, 2012

First Submission Date that Met QC Criteria

Jun 20, 2012

First Posted Date

Jun 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2012

Last Update Posted Date

Jun 21, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Not provided

Description

Enrollment

343Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

pain management and surgical outpatient department of a University hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital Bergmannsheil		Bochum			Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24452648	Derived	Kipping K, Maier C, Bussemas HH, Schwarzer A. Medication compliance in patients with chronic pain. Pain Physician. 2014 Jan-Feb;17(1):81-94.

ID	Term
D010146	Pain
D055118	Medication Adherence
D009293	Opioid-Related Disorders

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010349	Patient Compliance