- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01225861
Prospective Study on the Use of Transdermal Analgesic Buprenorphine Patches for Chronic Pain in the UK
May 14, 2014 updated by: Mundipharma Research Limited
The primary objective of the study is the descriptive analysis of incidence & severity of side effects & reasons for discontinuation of the treatment of chronic pain with transdermal analgesic Buprenorphine patches.
Study Overview
Status
Completed
Conditions
Detailed Description
750 patients that are treated with transdermal Buprenorphine patches for chronic pain will be included in the study.
About 20% of patients are aimed to be patch-naive, ie have received their first prescription of transdermal analgesic patches within 1 month before inclusion in this observational study.
Furthermore the study should not include more than 25% of cancer patients that are treated for chronic pain in order to ensure an appropriate mix of patient population.
Study Type
Observational
Enrollment (Anticipated)
750
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Glasgow, United Kingdom, G11 6NT
- Western Infirmary, Terrent Institute
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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
Non-Probability Sample
Study Population
Patients experiencing pain.
They may be from primary or secondary care.
Description
Inclusion Criteria
- Patient age > 18
- Patient is treated with transdermal Buprenorphine
- The patient is able to answer the patient's survey & has an estimated overall survival of minimum 6 months
- The patient gives his/her informed, written consent to participate in the study
Exclusion Criteria
- Patient Age < 18
- Patient has less than 6 months survival expectancy
- Patient is unable to answer the patient survey for whatever reason in any feasible form
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 |
Measure Description |
Time Frame |
---|---|---|
The incidence and severity of side effects
Time Frame: patients observed for 6 months
|
Descriptive analysis of incidence and severity of side effects and reasons for discontinuation with Buprenorphine patches.
Safety Issue - No
|
patients observed for 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment patterns
Time Frame: patients observed for 6 months
|
Insight into patient profiles treatment patterns and satisfaction.
|
patients observed for 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
November 1, 2010
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
October 20, 2010
First Submitted That Met QC Criteria
October 20, 2010
First Posted (Estimate)
October 21, 2010
Study Record Updates
Last Update Posted (Estimate)
May 15, 2014
Last Update Submitted That Met QC Criteria
May 14, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 241437
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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