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

NCT ID: NCT01225861

Last Updated: 2014-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mundipharma Research Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Western Infirmary, Terrent Institute

Glasgow, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 26547914 (View on PubMed)

Other Identifiers

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241437

Identifier Type: -

Identifier Source: org_study_id

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