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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 14, 2014
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014