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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01225861
First Posted: October 21, 2010
Last Update Posted: May 15, 2014
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):
Mundipharma Research Limited
October 20, 2010
October 21, 2010
May 15, 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 ]
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 ]
Insight into patient profiles treatment patterns and satisfaction.
Same as current
Not Provided
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
Not Provided
Not Provided
Non-Probability Sample
Patients experiencing pain. They may be from primary or secondary care.
Chronic Pain
Not Provided
Not Provided
Serpell M, Tripathi S, Scherzinger S, Rojas-Farreras S, Oksche A, Wilson M. Assessment of Transdermal Buprenorphine Patches for the Treatment of Chronic Pain in a UK Observational Study. Patient. 2016 Feb;9(1):35-46. doi: 10.1007/s40271-015-0151-y.

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01225861
241437
No
Not Provided
Not Provided
Mundipharma Research Limited
Mundipharma Research Limited
Not Provided
Not Provided
Mundipharma Research Limited
May 2014