or Peripheral Nerve Injury (PNI)Phase 4LIFTNCT01416116
Method of Pre-treatment for Application of QUTENZA Capsaicin 8% Patch
A Phase 4 study testing QUTENZA, Lidocaine and Tramadol in people with or Peripheral Nerve Injury (PNI) and Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN), run by Astellas Pharma Inc at 20 sites in 7 countries.
Trial summary
The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic is applied prior to the application of QUTENZA. This is a multi-center, randomized, assessor-blinded study which will investigate the use of an oral analgesic as an alternative form of pre-treatment for QUTENZA. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- or Peripheral Nerve Injury (PNI), Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)
- What is being tested?
- QUTENZA, Lidocaine and Tramadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 20 sitesin 7 countries
- Study dates
- 6 Jul 2011to 25 Apr 2012
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of postherpetic neuralgia or neuropathic pain due to peripheral nerve injury
- Daily pain score ≥ 4 for average pain both at the Screening Visit and at the Treatment Visit
- Intact, non-irritated, dry skin over the painful area(s) to be treated
Who cannot join
- Significant ongoing or recurrent pain other than due to PHN or peripheral nerve injury
- Past or current history of Type I or Type II diabetes mellitus
- Active malignancy or treatment for malignancy within a year prior to the Treatment Visit
Trial locations and contacts
20 sites in 7 countries.
20 sites in 7 countries
United Kingdom4 sites
Site 702
Glasgow
Site 701
Liverpool
Site 704
Manchester
Site 703
Solihull
About this study
Official title: Tolerability of QUTENZATM When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study
The Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic is applied prior to the application of QUTENZA. This is a multi-center, randomized, assessor-blinded study which will investigate the use of an oral analgesic as an alternative form of pre-treatment for QUTENZA.
Read the detailed description
All patients will be treated with QUTENZA for 60 minutes. Patients will be randomized to one of two arms- application of topical anaesthetic (lidocaine cream) or an oral analgesic (tramadol oral tables) prior to application of QUTENZA. Patients will be followed up for 7 days to monitor pain scores and tolerability.
- Conditions
- or Peripheral Nerve Injury (PNI), Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)
- Being tested
- QUTENZA, Lidocaine, Tramadol
- Keywords
- Tramadol, QUTENZA, Pre-treatment, Tolerability
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUTENZADrug
Also called capsaicin 8% patch
topical
LidocaineDrug
topical
TramadolDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| Tramadol | Experimental | Tramadol prior to QUTENZA Receives: Drug: QUTENZA; Drug: Tramadol |
| Lidocaine | Experimental | Lidocaine prior to QUTENZA Receives: Drug: QUTENZA; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who tolerate QUTENZA treatment
A QUTENZA tolerant subject is defined as a subject receiving at least 90% of the intended patch duration.
Measured: 60 minute application period
Secondary outcomes (4)
Duration of patch application
Measured: 60 minutes
Change in pain scores from baseline to subsequent timepoints on the day of patch application
Measured: 5, 25, 55, 85, 115 minutes on day of application and once a day on days 1, 2, 3
Proportion of subjects using pain medications and dose of pain medication(s) administered
Measured: day 1-5
Subject rated tolerability score
Measured: Baseline to end of study visit, day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study start6 Jul 2011
- Primary completion25 Apr 2012
- Study completion25 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for or Peripheral Nerve Injury (PNI)Studies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Study Manager, Late Phase Clinical Development & Operations, Study director, Astellas Pharma Europe Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416116
- Sponsor's protocol ID
- QTZ-EC-0002
- Other IDs
- 2010-023258-34
- Acronym
- LIFT
- Status last verified
- Apr 2018
- First submitted
- 11 Aug 2011
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability of QUTENZATM When Applied After Pre-treatment With Lidocaine or Tramadol in Subjects With Peripheral Neuropathic Pain - A Randomized, Multi-center, Assessor-blinded Study
- ClinicalTrials.gov ID
- NCT01416116
- Acronym / sponsor ID
- LIFT / QTZ-EC-0002
- Conditions
- or Peripheral Nerve Injury (PNI), Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN)
- Keywords
- Tramadol, QUTENZA, Pre-treatment, Tolerability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2011 (actual)
- Primary completion
- 25 Apr 2012 (actual)
- Study completion
- 25 Apr 2012 (actual)
- First posted
- 12 Aug 2011 (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 Summary of product characteristics (SmPC) for QUTENZA advises that topical anaesthetic is applied prior to the application of QUTENZA. This is a multi-center, randomized, assessor-blinded study which will investigate the use of an oral analgesic as an alternative form of pre-treatment for QUTENZA.
Detailed description
All patients will be treated with QUTENZA for 60 minutes. Patients will be randomized to one of two arms- application of topical anaesthetic (lidocaine cream) or an oral analgesic (tramadol oral tables) prior to application of QUTENZA. Patients will be followed up for 7 days to monitor pain scores and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tramadol | Experimental | Drug: QUTENZA, Drug: TramadolTramadol prior to QUTENZA |
| Lidocaine | Experimental | Drug: QUTENZA, Drug: LidocaineLidocaine prior to QUTENZA |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of postherpetic neuralgia or neuropathic pain due to peripheral nerve injury
- Daily pain score ≥ 4 for average pain both at the Screening Visit and at the Treatment Visit
- Intact, non-irritated, dry skin over the painful area(s) to be treated
Key exclusion criteria (3 listed)
- Significant ongoing or recurrent pain other than due to PHN or peripheral nerve injury
- Past or current history of Type I or Type II diabetes mellitus
- Active malignancy or treatment for malignancy within a year prior to the Treatment Visit
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 |
|---|---|---|
| QUTENZAAlso: capsaicin 8% patchtopical | Drug | Lidocaine, Tramadol |
| Lidocainetopical | Drug | Lidocaine |
| Tramadoloral | Drug | Tramadol |
Primary outcome
The proportion of subjects who tolerate QUTENZA treatment
Time frame: 60 minute application period
A QUTENZA tolerant subject is defined as a subject receiving at least 90% of the intended patch duration.
4 secondary outcomes
Duration of patch application
Time frame: 60 minutes
Change in pain scores from baseline to subsequent timepoints on the day of patch application
Time frame: 5, 25, 55, 85, 115 minutes on day of application and once a day on days 1, 2, 3
Proportion of subjects using pain medications and dose of pain medication(s) administered
Time frame: day 1-5
Subject rated tolerability score
Time frame: Baseline to end of study visit, day 7
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 23 Apr 2018.
- Individual participant dataSharing planned: Undecided
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.
Senior Study Manager, Late Phase Clinical Development & Operations study director
Astellas Pharma Europe Limited
20 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing QUTENZA, Lidocaine and Tramadol in people with or Peripheral Nerve Injury (PNI) and Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN), run by Astellas Pharma Inc at 20 sites in 7 countries.
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 3 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 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Ireland, United Kingdom, Belgium, Czechia, Denmark and 2 more countries. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 proportion of subjects who tolerate QUTENZA treatment (time frame: 60 minute application period). 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 23 Apr 2018.