Peripheral Neuropathic PainNEP-TUNENCT01524796
NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions in Denmark
An observational study of Peripheral Neuropathic Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
Observational study to assess the effectiveness and use of pregabalin (Lyrica) in the treatment of patients with peripheral neuropathic pain in real-life daily clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathic Pain
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Mar 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: When a subject, independently of the study and before consideration for observation in the study has been prescribed pregabalin for treatment of peripheral NeP, the subject can (before first dose of pregabalin is taken) be included in the observational program.
Who may be able to join
- Subjects aged 18 years or over.
- Subjects diagnosed with peripheral neuropathic pain.
- Subjects that independently of the study and before consideration for observation in the study have been prescribed pregabalin for treatment of peripheral neuropathic pain either.
- for the first time ('first prescription patients') or
- that have not used pregabalin within the previous 6 months but are prescribed pregabalin again ('re-treatment patients')
- Subjects that haven't taken the first dose of the prescribed pregabalin yet.
Who cannot join
- Subjects not consenting to participate.
- Subjects that at study inclusion (baseline) are on treatment with pregabalin for generalized anxiety or epilepsy.
About this study
Official title: NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions In Denmark
Observational study to assess the effectiveness and use of pregabalin (Lyrica) in the treatment of patients with peripheral neuropathic pain in real-life daily clinical practice.
Read the detailed description
General practitioners and specialists participate in the study. When a subject, independently of the study and before consideration for observation in the study has been prescribed pregabalin for treatment of peripheral NeP, the subject can (before first dose of pregabalin is taken) be included in the observational program.
- Conditions
- Peripheral Neuropathic Pain
- Being tested
- No intervention. Non-interventional study
- Keywords
- Real-life, non-interventional, observational, peripheral neuropathic pain, Lyrica, pregabalin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. Non-interventional studyOther
Also called pregabalin (Lyrica)
No intervention. Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Patients with peripheral neuropathic pain treated with Lyrica | Not described Receives: Other: No intervention. Non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline In Average Pain Level At Month 3 Telephonic Interview
Pain was assessed on an 11-point numeric rating scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Measured: Baseline, Month 3 Telephonic Interview
Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview
Pain was assessed on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Measured: Baseline, Month 3 Telephonic Interview
Change From Baseline In Least Pain Level At Month 3 Telephonic Interview
Pain was assessed on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Measured: Baseline, Month 3 Telephonic Interview
Secondary outcomes (7)
Sleep Interference Scale Score
Sleep Interference was assessed on an 11-point Sleep Numeric Rating Scale (NRS-11) where a score of 0 indicated "pain did not interfere with sleep" and a score of 10 indicated "pain completely interfered with sleep". Here, "n" signifies "Number of participants" for Baseline and Month 3 telephone interview whereas "n" signifies "number of observations" for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Measured: Baseline, Month 1, 2, 3, Month 3 telephonic interview
Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
Measured: Month 3 telephonic interview
Health-related Quality of Life Scale Score
Health-related Quality of Life was measured using Euro Quality of Life-5 dimensions (EQ-5D) scale. EQ-5D is a standardized generic instrument to assess health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The scale rates current participant's health state on a scale from 0 (worst imaginable health state) to 1 (best imaginable health state); higher scores indicate a better health state. Here, "n" signifies "Number of participants" for Baseline whereas "n" signifies "number of observations" for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Measured: Baseline, Month 1, 2, 3
Work Productivity and Activity Impairment (WPAI) Questionnaire
WPAI questionnaire assess work productivity and impairment. It is a patient-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past seven days. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, "n" signifies "Number of participants" for Baseline whereas "n" signifies "number of observations" for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Measured: Baseline, Month 1, 2, 3
Pregabalin Dose
Here, "n" signifies "Number of participants" for Baseline and Month 3 telephone interview whereas "n" signifies "number of observations" for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Measured: After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic Interview
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.
Measured: Before Baseline, Month 1, 2, 3 Visit
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.
Measured: After Baseline, Month 1, 2, 3 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Neuropathic 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524796
- Sponsor's protocol ID
- A0081292
- Other IDs
- NEP-TUNE
- Acronym
- NEP-TUNE
- Status last verified
- Mar 2015
- First submitted
- 12 Dec 2011
- Last updated
- 28 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions In Denmark
- ClinicalTrials.gov ID
- NCT01524796
- Acronym / sponsor ID
- NEP-TUNE / A0081292
- Conditions
- Peripheral Neuropathic Pain
- Keywords
- Real-life, non-interventional, observational, peripheral neuropathic pain, Lyrica, pregabalin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Posted 31 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study to assess the effectiveness and use of pregabalin (Lyrica) in the treatment of patients with peripheral neuropathic pain in real-life daily clinical practice.
Detailed description
General practitioners and specialists participate in the study. When a subject, independently of the study and before consideration for observation in the study has been prescribed pregabalin for treatment of peripheral NeP, the subject can (before first dose of pregabalin is taken) be included in the observational program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with peripheral neuropathic pain treated with Lyrica | – | Other: No intervention. Non-interventional study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- When a subject, independently of the study and before consideration for observation in the study has been prescribed pregabalin for treatment of peripheral NeP, the subject can (before first dose of pregabalin is taken) be included in the observational program.
Key inclusion criteria (6 listed)
- Subjects aged 18 years or over.
- Subjects diagnosed with peripheral neuropathic pain.
- Subjects that independently of the study and before consideration for observation in the study have been prescribed pregabalin for treatment of peripheral neuropathic pain either.
- Subjects that haven't taken the first dose of the prescribed pregabalin yet.
Key exclusion criteria (2 listed)
- Subjects not consenting to participate.
- Subjects that at study inclusion (baseline) are on treatment with pregabalin for generalized anxiety or epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention. Non-interventional studyAlso: pregabalin (Lyrica)No intervention. Non-interventional study | Other | Patients with peripheral neuropathic pain treated with Lyrica |
Primary outcome
Change From Baseline In Average Pain Level At Month 3 Telephonic Interview
Time frame: Baseline, Month 3 Telephonic Interview
Pain was assessed on an 11-point numeric rating scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview
Time frame: Baseline, Month 3 Telephonic Interview
Pain was assessed on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Change From Baseline In Least Pain Level At Month 3 Telephonic Interview
Time frame: Baseline, Month 3 Telephonic Interview
Pain was assessed on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
7 secondary outcomes
Sleep Interference Scale Score
Time frame: Baseline, Month 1, 2, 3, Month 3 telephonic interview
Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)
Time frame: Month 3 telephonic interview
Health-related Quality of Life Scale Score
Time frame: Baseline, Month 1, 2, 3
Work Productivity and Activity Impairment (WPAI) Questionnaire
Time frame: Baseline, Month 1, 2, 3
Pregabalin Dose
Time frame: After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic Interview
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
Time frame: Before Baseline, Month 1, 2, 3 Visit
Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
Time frame: After Baseline, Month 1, 2, 3 visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Neuropathic Pain, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
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 6 inclusion and 2 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 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 31 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline In Average Pain Level At Month 3 Telephonic Interview (time frame: Baseline, Month 3 Telephonic Interview). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2021.