Prospective Study on the Use of Transdermal Analgesic Bup... | NCT01225861

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

NCT01225861

Sponsor

Mundipharma Research Limited

Status

Completed

Last Update Posted

May 15, 2014Estimated

Enrollment

750Estimated

Phase

Not provided

Conditions

Chronic Pain

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Aug 2013Actual

Completion Date

Jan 2014Actual

First Submitted Date

Oct 20, 2010

First Submission Date that Met QC Criteria

Oct 20, 2010

First Posted Date

Oct 21, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2014

Last Update Posted Date

May 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

750Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Treatment patterns	Insight into patient profiles treatment patterns and satisfaction.	patients observed for 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Western Infirmary, Terrent Institute		Glasgow		G11 6NT	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26547914	Derived	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.

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms