Chronic PainNCT01225861
Prospective Study on the Use of Transdermal Analgesic Buprenorphine Patches for Chronic Pain in the UK
An observational study of Chronic Pain, run by Mundipharma Research Limited at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- How many people
- 750 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2010to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients experiencing pain. They may be from primary or secondary care.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Western Infirmary, Terrent Institute
Glasgow, G11 6NT
About this study
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.
Read the 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.
- Conditions
- Chronic Pain
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: patients observed for 6 months
Secondary outcomes (1)
Treatment patterns
Insight into patient profiles treatment patterns and satisfaction.
Measured: patients observed for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionAug 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mundipharma Research Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225861
- Sponsor's protocol ID
- 241437
- Status last verified
- May 2014
- First submitted
- 20 Oct 2010
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26547914
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Use of Transdermal Analgesic Buprenorphine Patches for Chronic Pain in the UK
- ClinicalTrials.gov ID
- NCT01225861
- Acronym / sponsor ID
- 241437
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Mundipharma Research LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 21 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients experiencing pain. They may be from primary or secondary care.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Treatment patterns
Time frame: patients observed for 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
- Derived from this study: PubMed 26547914Serpell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Mundipharma Research Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of side effects (time frame: patients observed for 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01225861, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2014.