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

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ClinicalTrials.gov Identifier: NCT01225861
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research Limited

Brief 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.

Condition or disease
Chronic Pain

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.

Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : November 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Treatment patterns [ Time Frame: patients observed for 6 months ]
    Insight into patient profiles treatment patterns and satisfaction.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225861


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mundipharma Research Limited
ClinicalTrials.gov Identifier: NCT01225861     History of Changes
Other Study ID Numbers: 241437
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: May 15, 2014
Last Verified: May 2014

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