Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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16 December 2013 |
Main ID: |
EUCTR2011-005872-41-IT |
Date of registration:
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03/08/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Comparison of efficacy and safety of Qutenza versus Lyrica
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Scientific title:
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QUTENZA versus pregabalin in subjects with peripheral neuropathic pain: an open-label, randomized, multicenter, non-inferiority efficacy and tolerability study. - ELEVATE |
Date of first enrolment:
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05/07/2012 |
Target sample size:
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526 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005872-41 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Austria
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Bulgaria
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Czech Republic
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Finland
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Germany
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Greece
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Hungary
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Italy
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Portugal
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Slovenia
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Spain
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Sweden
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United Kingdom
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Contacts
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Name:
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Servizio Informazione sulla Sperime
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Address:
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Via Delle Industrie
20061
Carugate Milano
Italy |
Telephone:
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02 921381 |
Email:
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CATIA.DICIANNI@IT.ASTELLAS.COM |
Affiliation:
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ASTELLAS PHARMA (AFFILIATE) |
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Name:
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Servizio Informazione sulla Sperime
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Address:
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Via Delle Industrie
20061
Carugate Milano
Italy |
Telephone:
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02 921381 |
Email:
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CATIA.DICIANNI@IT.ASTELLAS.COM |
Affiliation:
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ASTELLAS PHARMA (AFFILIATE) |
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Key inclusion & exclusion criteria
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Inclusion criteria: Subjects are eligible for the study if all of the following apply: 1.Male or female between 18 and 80 years of age, inclusive 2.In good health as determined by the investigator 3.Documented diagnosis of probable or definite PNP [Treede et al, 2008] 4.Localized and well-defined area of PNP, suitable for treatment with QUTENZA 5.Documented diagnosis at the Baseline Visit of either: a.Postherpetic neuralgia (PHN) with pain persisting at least 6 months since shingles vesicle crusting b.Peripheral nerve injury (PNI) including post-surgical or post-traumatic neuropathic pain, persisting for a minimum of 3 months c.Non-diabetic painful peripheral polyneuropathy with pain which has persisted for a minimum of 3 months, including (i) small-fiber neuropathy, as confirmed by quantitative sensory testing (QST), laser evoked potentials (LEP) or skin biopsy, (ii) chemotherapy induced neuropathy in subjects with stable neoplastic disease, (iii) other, adequately characterized painful peripheral polyneuropathy, based on clinical history and examination 6.Average pain score =4 during Screening Period, over a minimum of at least 4 consecutive days (using the “average pain for the past 24 hours” Numeric Pain Rating Scale (NPRS) score 7.Intact, non-irritated, dry skin over the painful area(s) to be treated 8.Is either: a.Naïve to treatment with pregabalin and gabapentin, OR b.In the opinion of the investigator, has not received an adequate trial of treatment with pregabalin or gabapentin 9.Subject is willing to receive pregabalin or QUTENZA as part of the trial 10.Females of child bearing potential must be willing to use highly effective methods of birth control during the study and for 30 days following study termination (a highly effective method of birth control is defined as those which result in a low failure rate (CHMP/ICH/286/95 modified) of less that 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner) 11.Willing and able to comply with protocol requirements for the duration of study participation 12.Given written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 263 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 263
Exclusion criteria: Subjects will be excluded from this clinical study if any of the following apply: 1. Significant ongoing or recurrent pain of etiology other than PHN, PNI or non-diabetic painful peripheral polyneuropathy, for example: compression-related neuropathies (e.g. spinal stenosis), radiculopathy, tumor-related pain, fibromyalgia or arthritis 2. Complex Regional Pain Syndrome (CRPS, Type I or II) 3. Neuropathic pain related to previously administered radiotherapy, diabetes mellitus or HIV-AN 4. Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes 5. Severe loss of heat sensation in the painful area, indicative of C-fiber denervation 6. Reported daily pain score of 10 on the NPRS for at least 4 days during the Screening Period 7. Past or current history of diabetes mellitus 8. Unstable or poorly controlled hypertension or a recent history of a cardiovascular event which, in the opinion of the investigator, would put the subject at risk of adverse cardiovascular reactions related to the patch application procedure 9. Creatinine clearance (CLcr) < 60mL/min according to the Cockcroft-Gault formula 10. Untreated ongoing generalized anxiety disorder according to DSM-IV or ICD-10 criteria 11. Severe ongoing depression according to DSM-IV or ICD-10 criteria 12. 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 13. Planned elective surgery during the trial 14. Changes to stable neuropathic pain background medication in the 4 weeks prior to the Baseline Visit 15. Any prior receipt of QUTENZA patches, including blinded patches administered as part of a clinical trial 16. Hypersensitivity to capsaicin (i.e., chilli peppers or Over-the-counter [OTC] capsaicin products), any QUTENZA excipients, local anesthetics, or adhesives 17. Treatment with pregabalin or gabapentin within 2 months prior to the Baseline Visit 18. Hypersensitivity to pregabalin or any of the excipients 19. Use of opioids exceeding a total daily dose of morphine of 200 mg/day, or equivalent; or any intravenous opioids or tapentadol, regardless of dose, within 7 days preceding the Baseline Visit 20. Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including patch containing lidocaine), steroids or capsaicin products on the painful areas to be treated within 7 days preceding the Baseline Visit 21. Chemotherapy within 3 months of the Baseline Visit, except maintenance hormone treatment 22. Use of any investigational agent within 30 days prior to Baseline Visit 23. Active substance abuse or history of chronic substance abuse within 1 year prior to screening; or any prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator 24. Female subjects of child-bearing potential with a positive serum or urine pregnancy test prior to treatment 25. Subject, who in the opinion of the investigator, is not suitable for the study for any reason.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Patients who have a documented diagnosis of probable or definite Peripheral Neuropathic Pain MedDRA version: 14.1
Level: LLT
Classification code 10054095
Term: Neuropathic pain
System Organ Class: 10029205 - Nervous system disorders
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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Trade Name: QUTENZA*1CER 179MG+1GEL DET Pharmaceutical Form: Medicated plaster INN or Proposed INN: CAPSAICIN CAS Number: 404-86-4 Current Sponsor code: NGX-4010 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 179-
Trade Name: LYRICA*100CPS 75MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: PREGABALIN CAS Number: 148553-50-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75-
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Primary Outcome(s)
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Main Objective: To compare the efficacy of Qutenza versus Pregabalin in subjects with peripheral neuropathic pain (PNP)after 8 weeks.
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Primary end point(s): The proportion of subjects in each arm who achieve at least a 30% decrease in the “average pain for the past 24 hours” NPRS score from baseline to Week 8
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Secondary Objective: •To compare the optimal therapeutic effect of QUTENZA versus pregabalin in subjects with PNP •To compare the: - onset of treatment effect associated with QUTENZA or pregabalin - tolerability of treatment with QUTENZA or pregabalin - effect of QUTENZA or pregabalin on cognition, sleep and health-related quality of life - satisfaction with treatment with QUTENZA or pregabalin - healthcare resource utilization following treatment with QUTENZA or pregabalin - safety of treatment with QUTENZA or pregabalin • To identify sensory symptoms predictive of a reduction in pain scores for subjects receiving QUTENZA • To evaluate the effect of treatment with QUTENZA or pregabalin on the intensity and area of allodynia • To examine the impact of pain relief and treatment tolerability on health-related quality of life as determined by the relationship between relevant endpoints.
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Timepoint(s) of evaluation of this end point: week 1-8
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Secondary Outcome(s)
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Secondary end point(s): ? Proportion of subjects in each arm who achieve “optimal therapeutic effect” Optimal therapeutic effect is defined as: - No change in background chronic pain medication and no discontinuation of study drug due to lack of efficacy or tolerability prior to Week 8 - At least a 30% reduction in the “average pain for the past 24 hours” NPRS score, from baseline to Week 8, and - No moderate or severe adverse drug reactions (ADRs) during the stable Treatment Period ? Proportion of subjects who achieve at least a 30% decrease in the “average pain for the past 24 hours” NPRS score from baseline to the mean of all scores recorded between Week 1 (Day 8) and Week 8 (Day 57), and complete 8 weeks of treatment ? Proportion of subjects who achieve at least a 50% decrease in the “average pain for the past 24 hours” NPRS score from baseline to Week 8, and from baseline to the mean of all scores recorded between Week 1 (Day 8) and Week 8 (Day 57), and complete 8 weeks of treatment ? Absolute and percent change in “average pain for the past 24 hours” NPRS score from baseline to Week 8, and from baseline to the mean of all scores recorded between Weeks 1 to 8 ? Time to onset of pain relief (in days) as assessed by at least a 30% reduction in “average pain for the past 24 hours” NPRS score ? Overall subject status using Patient Global Impression of Change (PGIC) questionnaire at Weeks 4 and 8 ? Change in the Medical Outcomes Study (MOS) 6-Item Cognitive Functioning Scale from baseline to Week 8 ? Change in the MOS – Sleep Scale from baseline to Weeks 4 and 8 ? Change in the EQ-5D-5L total score from baseline to Week 8 ? Treatment satisfaction as assessed by: - Proportion of subjects who discontinue study drug or withdraw from the study due to either a lack of efficacy or tolerability - Willingness to continue treatment at Week 8 - Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire at Week 4 and 8 ? Time to reach optimal maintenance dose for pregabalin ? Resource use (number of contacts with health professionals) ? Tolerability (assessed by the number, severity and duration of ADRs), collected as self-rated health-related complaints by the subject and then medically confirmed and causality assigned by the investigator ? Change in intensity and area of allodynia from baseline to Week 8 ? Changes in sensory symptoms between baseline and Week 8 assessed using Neuropathic Pain Symptom Inventory (NPSI) scores ? Reduction in pain by the pattern of sensory symptoms as defined using NPSI scores at baseline
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Timepoint(s) of evaluation of this end point: week 1-8
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Secondary ID(s)
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2011-005872-41-SE
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QTZ-EC-0004
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Source(s) of Monetary Support
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Astellas Pharma Europe Ltd
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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