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: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition
Chronic Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Mundipharma Research Limited:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Treatment patterns [ Time Frame: patients observed for 6 months ] [ Designated as safety issue: No ]
    Insight into patient profiles treatment patterns and satisfaction.


Estimated Enrollment: 750
Study Start Date: November 2010
Study Completion Date: January 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225861

Locations
United Kingdom
Western Infirmary, Terrent Institute
Glasgow, United Kingdom, G11 6NT
Sponsors and Collaborators
Mundipharma Research Limited
  More Information

No publications provided

Responsible Party: Mundipharma Research Limited
ClinicalTrials.gov Identifier: NCT01225861     History of Changes
Other Study ID Numbers: 241437
Study First Received: October 20, 2010
Last Updated: February 13, 2014
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on April 23, 2014