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

Chronic Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01225861
• Other study ID #: 241437
• Status: Completed
• Phase: N/A
• First received: October 20, 2010
• Last updated: May 14, 2014
• Start date: November 2010
• Est. completion date: January 2014

Study information

• Verified date: May 2014
• Source: Mundipharma Research Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: January 2014
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain

Locations

Country	Name	City	State
United Kingdom	Western Infirmary, Terrent Institute	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Research Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence and severity of side effects	Descriptive analysis of incidence and severity of side effects and reasons for discontinuation with Buprenorphine patches. Safety Issue - No	patients observed for 6 months	No
Secondary	Treatment patterns	Insight into patient profiles treatment patterns and satisfaction.	patients observed for 6 months	No