Neuralgia, PostherpeticPhase 4STRIDENCT01252160
Safety and Effectiveness of Repeated Administration of QUTENZA Patches for Treatment of Pain Caused by Nerve Damage
A Phase 4 study testing QUTENZA in people with Neuralgia, Postherpetic, run by Astellas Pharma Inc at 64 sites in 16 countries.
Trial summary
In this study all patients will be treated with the same medicine, the QUTENZA patch. Subjects will receive up to 6 QUTENZA patch applications over 12 months. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neuralgia, Postherpetic
- What is being tested?
- QUTENZA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 64 sitesin 16 countries
- Study dates
- 28 Oct 2010to 26 Sep 2013
- 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
None listed.
Who cannot join
- Any prior receipt of QUTENZA open label or blinded study patches
- Use of oral or transdermal opioids exceeding a total daily dose of morphine of 80 mg/day, or equivalent; or any parenteral opioids, regardless of dose, within 7 days preceding the first patch application visit
- Lack of an effective pain medication strategy for the subject, such as unwillingness to use opioid analgesics during study treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with oxycodone or other analgesic, as judged by the investigator
- Active substance abuse or history of chronic substance abuse within 1 year prior to enrolment or prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator
- Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics, steroids or capsaicin products on the painful areas within 7 days preceding the first patch application visit
- Current use of any investigational agent (excluding antiretrovirals in Phase 3 evaluation to treat HIV infection)
Show all 20Show fewer
- Unstable or poorly controlled hypertension or a recent history of a cardiovascular event which, in the opinion of the investigator, would put the patient at risk of adverse cardiovascular reactions related to the patch application procedure
- Evidence of another contributing cause for peripheral neuropathy, and/or treatment within 90 days prior to screening visit with any drug that may have contributed to the sensory neuropathy
- Past or current history of Type I or Type II diabetes mellitus
- Current psychotic disorders
- Clinically significant abnormal ECG at screening
- Hypersensitivity to capsaicin (i.e., chilli peppers or Over-the-counter [OTC] capsaicin products), any QUTENZA excipients, local anesthetics, oxycodone, hydrocodone, or adhesives
- Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events
- Significant pain of an aetiology other than painful HIV-AN, PHN, PNI, ISNN or other adequately characterized PNP for example, compression-related neuropathies (e.g., spinal stenosis), fibromyalgia or arthritis
- Posttraumatic neuropathic pain due to Complex Regional Pain Syndrome (CRPS, Type I)
- Active malignancy or history of malignancy during the past 5 years (a history of squamous cell carcinoma or a basal cell carcinoma not involving the area to be treated is allowed)
- Evidence of cognitive impairment including dementia that may interfere with subject's ability to complete study evaluations and recall pain levels in the past 24 hours
- Planned elective surgery during the trial
- Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes
- Female subjects of child-bearing potential with a positive serum or urine pregnancy test prior to treatment
Trial locations and contacts
64 sites in 16 countries.
64 sites in 16 countries
Spain11 sites
Study site
Badalona, 08025
Study site
Barakaldo, 48903
Study site
Barcelona, 08035
Study site
Barcelona, 8025
Study site
Cataluna, 8025
Study site
Ferrol, 15405
Study site
Granada, 18014
Study site
Madrid, 28006
Study site
Madrid, 28034
Study site
Málaga, 29010
Study site
Salamanca, 37007
Italy9 sites
Study site
Chieti, 66100
Study site
Milan, 20132
Study site
Naples, 80131
Study site
Palermo, 90146
Study site
Pavia, 27100
Study site
Rimini, 47900
Study site
Rionero in Vulture, 85028
Study site
Roma, 00149
Study site
Taormina, 98039
United Kingdom9 sites
Study site
Brighton, BN2 1ES
Study site
Edinburgh, EH4 2XU
Study site
Glasgow, G12 0YN
Study site
Liverpool, L97LJ
Study site
London, E11BB
Study site
London, SE1 7EH
Study site
London, SW10 9NH
Study site
London, SW17 0QT
Study site
Solihull, B91 2LJ
France6 sites
Study site
Boulogne-Billancourt, 92100
Study site
Nice, 06002
Study site
Paris, 75012
Study site
Paris, 75018
Study site
Paris, 75651
Study site
Saint-Etienne, 42055
Belgium5 sites
Study site
Antwerp, 2000
Study site
Brussels, 1000
Study site
Edegem, 2650
Study site
Genk, 3600
Study site
Roeselare, 8800
Czechia4 sites
Study site
Brno-Bohunice, 625 00
Study site
Plzen-Lochotin, 304 60
Study site
Prague, 150 06
Study site
Prague, 180 81
Poland4 sites
Study site
Bydgoszcz, 85-094
Study site
Katowice, 40-662
Study site
Lodz, 94-238
Study site
Warsaw, 00-416
About this study
Official title: A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pain
In this study all patients will be treated with the same medicine, the QUTENZA patch. Subjects will receive up to 6 QUTENZA patch applications over 12 months.
Read the detailed description
The rationale for the current study is to evaluate the safety of repeated QUTENZA applications, including the effect of QUTENZA on sensory function in subjects diagnosed with different types of Peripheral Neuropathic Pain (PNP). In order to adequately assess the long-term safety QUTENZA in well defined patient populations the current study will enroll a minimum of 100 patients each with HIV-Associated Neuropathy (HIV-AN) and Postherpetic Neuralgia (PHN).
- Conditions
- Neuralgia, Postherpetic
- Being tested
- QUTENZA
- Keywords
- Neuralgia, Postherpetic, QUTENZA
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUTENZADrug
Cutaneous patch
| Study group | Role | What they receive |
|---|---|---|
| QUTENZA | Experimental | Cutaneous patch Receives: Drug: QUTENZA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Measured: Throughout the study up to 65 weeks
Serious adverse events (SAEs)
Measured: Throughout the study up to 65 weeks
Treatment-emergent adverse events
Measured: Throughout the study up to 65 weeks
Proportion of subjects who prematurely terminate from the study due to an AE
Measured: Throughout the study up to 65 weeks
Change in Sensory function
Measured: All visits throughout the study up to 65 weeks
Secondary outcomes (12)
Use of concomitant pain medications following each patch application
Measured: Throughout the study up to 65 weeks
Change from baseline in Vital signs
Measured: All visits throughout the study up to 65 weeks
Dermal assessment score
Measured: All visits throughout the study up to 65 weeks
The proportion of subjects completing at least 90% of the intended patch application duration
Measured: All visits throughout the study up to 65 weeks
Neurological assessment
Measured: All visits throughout the study up to 65 weeks
Brief Pain Inventory (BPI)
Measured: Throughout the study up to 65 weeks
Patient Global Impression of Change (PGIC)
Measured: All visits throughout the study except the first patch application visit up to 65 weeks
European Quality of life questionnaire in 5 Dimensions (EQ5D)
Measured: All visits throughout the study except the screening visit and unscheduled visits up to 65 weeks
Hospital Anxiety and Depression Score (HADS)
Measured: All visits throughout the study except the screening visit and unscheduled visits up to 65 weeks
Work Productivity and Activity Impairment Questionnaire: Neuropathic Pain (WPAI:NP)
Measured: All visits throughout the study except the screening visit and unscheduled visits up to 65 weeks
Self-Assessment of Treatment (SAT) questionnaire
Measured: At the Week 26 visit and planned or early termination visit no later than week 65
Change in use of concomitant pain medications
Measured: Throughout the study up to 65 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study start28 Oct 2010
- Primary completion26 Sep 2013
- Study completion26 Sep 2013
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 Neuralgia, PostherpeticStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252160
- Sponsor's protocol ID
- E05-CL-3001
- Other IDs
- 2009-016457-18, 2009
- Acronym
- STRIDE
- Status last verified
- Apr 2018
- First submitted
- 1 Dec 2010
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
PubMed 36729473
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT01252160
- Acronym / sponsor ID
- STRIDE / E05-CL-3001
- Conditions
- Neuralgia, Postherpetic
- Keywords
- Neuralgia, Postherpetic, QUTENZA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2010 (actual)
- Primary completion
- 26 Sep 2013 (actual)
- Study completion
- 26 Sep 2013 (actual)
- First posted
- 2 Dec 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.
In this study all patients will be treated with the same medicine, the QUTENZA patch. Subjects will receive up to 6 QUTENZA patch applications over 12 months.
Detailed description
The rationale for the current study is to evaluate the safety of repeated QUTENZA applications, including the effect of QUTENZA on sensory function in subjects diagnosed with different types of Peripheral Neuropathic Pain (PNP). In order to adequately assess the long-term safety QUTENZA in well defined patient populations the current study will enroll a minimum of 100 patients each with HIV-Associated Neuropathy (HIV-AN) and Postherpetic Neuralgia (PHN).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QUTENZA | Experimental | Drug: QUTENZACutaneous patch |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- Any prior receipt of QUTENZA open label or blinded study patches
- Use of oral or transdermal opioids exceeding a total daily dose of morphine of 80 mg/day, or equivalent; or any parenteral opioids, regardless of dose, within 7 days preceding the first patch application visit
- Lack of an effective pain medication strategy for the subject, such as unwillingness to use opioid analgesics during study treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with oxycodone or other analgesic, as judged by the investigator
- Active substance abuse or history of chronic substance abuse within 1 year prior to enrolment or prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator
- Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics, steroids or capsaicin products on the painful areas within 7 days preceding the first patch application 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 |
|---|---|---|
| QUTENZACutaneous patch | Drug | QUTENZA |
Primary outcome
Adverse events (AEs)
Time frame: Throughout the study up to 65 weeks
Serious adverse events (SAEs)
Time frame: Throughout the study up to 65 weeks
Treatment-emergent adverse events
Time frame: Throughout the study up to 65 weeks
Proportion of subjects who prematurely terminate from the study due to an AE
Time frame: Throughout the study up to 65 weeks
Change in Sensory function
Time frame: All visits throughout the study up to 65 weeks
12 secondary outcomes
Use of concomitant pain medications following each patch application
Time frame: Throughout the study up to 65 weeks
Change from baseline in Vital signs
Time frame: All visits throughout the study up to 65 weeks
Dermal assessment score
Time frame: All visits throughout the study up to 65 weeks
The proportion of subjects completing at least 90% of the intended patch application duration
Time frame: All visits throughout the study up to 65 weeks
Neurological assessment
Time frame: All visits throughout the study up to 65 weeks
Brief Pain Inventory (BPI)
Time frame: Throughout the study up to 65 weeks
Patient Global Impression of Change (PGIC)
Time frame: All visits throughout the study except the first patch application visit up to 65 weeks
European Quality of life questionnaire in 5 Dimensions (EQ5D)
Time frame: All visits throughout the study except the screening visit and unscheduled visits up to 65 weeks
Hospital Anxiety and Depression Score (HADS)
Time frame: All visits throughout the study except the screening visit and unscheduled visits up to 65 weeks
Work Productivity and Activity Impairment Questionnaire: Neuropathic Pain (WPAI:NP)
Time frame: All visits throughout the study except the screening visit and unscheduled visits up to 65 weeks
Self-Assessment of Treatment (SAT) questionnaire
Time frame: At the Week 26 visit and planned or early termination visit no later than week 65
Change in use of concomitant pain medications
Time frame: Throughout the study up to 65 weeks
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 19 Apr 2018.
- Derived from this study: PubMed 36729473Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
- Link to results on EudraCT websiteLink provided by the sponsor.
Related trials for Neuralgia, Postherpetic
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Active, not recruitingObservational study
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
Herpes Zoster (HZ)
Recruiting
The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
Herpes Zoster, Pain
Not yet recruiting
Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
Herpes Zoster Pain
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.
Use Central Contact study chair
Astellas Pharma Europe Ltd.
64 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing QUTENZA in people with Neuralgia, Postherpetic, run by Astellas Pharma Inc at 64 sites in 16 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 0 inclusion and 20 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 19 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 64 sites in Spain, Italy, United Kingdom, France, Belgium and 11 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?
Adverse events (AEs) (time frame: Throughout the study up to 65 weeks). The study lists 5 primary outcomes in all. 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 NCT01252160, 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 19 Apr 2018.