PainNCT01625065
Study of Medication Compliance - a Comparison of Patients in Pain Management and Pre-surgical Patients
An observational study of Pain, run by Ruhr University of Bochum at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- How many people
- 343 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: pain management and surgical outpatient department of a University hospital
Who may be able to join
- provided informed consent
- current pain
Who cannot join
- no taking of blood sample possible
- no consent with toxicological analyzes
- insufficient comprehension of the German language
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Pain
- Keywords
- medication compliance, adherence, toxicological analyzes, GC-MS, HPLC, pain patients, opioid misuse, patients with current pain
- Medical subject headings
- Pain, Medication Adherence, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startMay 2010
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Maier, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625065
- Sponsor's protocol ID
- Medi-3889-10
- Status last verified
- Jun 2012
- First submitted
- 19 Jun 2012
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kipping K, Maier C, Bussemas HH, Schwarzer A. Medication compliance in patients with chronic pain. Pain Physician. 2014 Jan-Feb;17(1):81-94.
PubMed 24452648
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01625065
- Acronym / sponsor ID
- Medi-3889-10
- Conditions
- Pain
- Keywords
- medication compliance, adherence, toxicological analyzes, GC-MS, HPLC, pain patients, opioid misuse, patients with current pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pain management and surgical outpatient department of a University hospital
Key inclusion criteria (2 listed)
- provided informed consent
- current pain
Key exclusion criteria (3 listed)
- no taking of blood sample possible
- no consent with toxicological analyzes
- insufficient comprehension of the German language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
- Derived from this study: PubMed 24452648Kipping K, Maier C, Bussemas HH, Schwarzer A. Medication compliance in patients with chronic pain. Pain Physician. 2014 Jan-Feb;17(1):81-94.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01625065, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2012.