Prospective Study on the Use of Transdermal Analgesic Buprenorphine Patches for Chronic Pain in the UK

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research Limited
ClinicalTrials.gov Identifier:
NCT01225861
First received: October 20, 2010
Last updated: May 14, 2014
Last verified: May 2014

October 20, 2010
May 14, 2014
November 2010
August 2013   (final data collection date for primary outcome measure)
The incidence and severity of side effects [ Time Frame: patients observed for 6 months ] [ Designated as safety issue: No ]
Descriptive analysis of incidence and severity of side effects and reasons for discontinuation with Buprenorphine patches. Safety Issue - No
Same as current
Complete list of historical versions of study NCT01225861 on ClinicalTrials.gov Archive Site
Treatment patterns [ Time Frame: patients observed for 6 months ] [ Designated as safety issue: No ]
Insight into patient profiles treatment patterns and satisfaction.
Same as current
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Not Provided
 
Prospective Study on the Use of Transdermal Analgesic Buprenorphine Patches for Chronic Pain in the UK
Not Provided

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients experiencing pain. They may be from primary or secondary care.

Chronic Pain
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
750
January 2014
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01225861
241437
No
Mundipharma Research Limited
Mundipharma Research Limited
Not Provided
Not Provided
Mundipharma Research Limited
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP