Main
|
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:
|
EUCTR |
Last refreshed on:
|
10 June 2014 |
Main ID: |
EUCTR2011-005872-41-BG |
Date of registration:
|
21/08/2012 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Comparison of efficacy and safety of Qutenza vs Lyrica
|
Scientific title:
|
QUTENZA versus pregabalin in subjects with peripheral
neuropathic pain: an open-label, randomized, multicenter, noninferiority efficacy and tolerability study - ELEVATE |
Date of first enrolment:
|
10/10/2012 |
Target sample size:
|
526 |
Recruitment status: |
Not Recruiting |
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005872-41 |
Study type:
|
Interventional clinical trial of medicinal product |
Study design:
|
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
|
Phase:
|
|
|
Countries of recruitment
|
Armenia
|
Austria
|
Belarus
|
Belgium
|
Bulgaria
|
Czech Republic
|
Finland
|
France
|
Georgia
|
Germany
|
Greece
|
Hungary
|
Italy
|
Netherlands
|
Poland
|
Portugal
|
Romania
|
Russian Federation
|
Slovakia
|
Slovenia
|
Spain
|
Sweden
|
Turkey
|
United Kingdom
|
Contacts
|
Name:
|
Departamento Médico
|
Address:
|
Paseo del club deportivo, nº 1, bloque 14, 2ª planta
28223
Pozuelo de Alarcón (Madrid)
Spain |
Telephone:
|
0034914 952 700 |
Email:
|
emilio.pedrosa@es.astellas.com |
Affiliation:
|
Astellas Pharma S.A. |
|
Name:
|
Departamento Médico
|
Address:
|
Paseo del club deportivo, nº 1, bloque 14, 2ª planta
28223
Pozuelo de Alarcón (Madrid)
Spain |
Telephone:
|
0034914 952 700 |
Email:
|
emilio.pedrosa@es.astellas.com |
Affiliation:
|
Astellas Pharma S.A. |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: 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. PHN with pain persisting at least 6 months since shingles vesicle crusting
b. 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 QST 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” 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: 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: 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
|
Health Condition(s) or Problem(s) studied
|
Patients who have a documented diagnosis of probable or definite Peripheral Neuropathic Pain MedDRA version: 16.0
Level: LLT
Classification code 10054095
Term: Neuropathic pain
System Organ Class: 100000004852
|
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
|
Intervention(s)
|
Trade Name: Qutenza 179 mg cutaneous patch Product Name: Qutenza 179 mg cutaneous patch Product Code: N/A Pharmaceutical Form: Medicated plaster INN or Proposed INN: capsaicin CAS Number: 404-86-4 Current Sponsor code: NGX-4010 Other descriptive name: CAPSAICIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 179-
Trade Name: Lyrica 75 mg hard capsules Product Name: Lyrica Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pregabalin CAS Number: 148553-50-8 Current Sponsor code: NA Other descriptive name: PREGABALIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75-
|
Primary Outcome(s)
|
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 hrs” NPRS score from baseline to week 8.
|
Main Objective: To compare the efficacy of QUTENZA versus pregabalin in subjects with peripheral neuropathic pain (PNP) after 8 weeks
|
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 cogintion, 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 vs pregabalin • To identify sensory symptoms that are predictive of a reduction in pain scores for subjects receiving QUTENZA. • To evaluate the effect of treatment with QUTENZA or pregabalin on the intensity 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.
|
Timepoint(s) of evaluation of this end point: wk 1-8
|
Secondary Outcome(s)
|
Secondary end point(s): ? Proportion of subjects in each arm who achieve "optimal therapeutic
effect".
Optimal therapeutic effect is defined as:
o No change in background chronic pain medication or discontinuation
of study drug due to lack of efficacy or tolerability prior to Week 8
o At least a 30% reduction in the "average pain for the past
24 hours"
o Treatment Satisfaction Questionnaire for Medication (TSQM)
questionnaire at Week 4 and Week 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
NPRS score, from baseline to Week 8, and
o No moderate or severe adverse drug reactions (ADRs) during the
stable treatment period (see section 5.5.4),
? 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)
? 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)
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
? Overall subject status using Patient Global Impression of Change
(PGIC) questionnaire at Weeks 4 and 8
? Change in the Medical Outcomes Study (MOS) – Cognitive Functioning
Scale from baseline to Week 8
? 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:
o Proportion of subjects who discontinue study drug or withdraw from
the study due to either a lack of efficacy or tolerability
o Willingness to continue treatment at Week 8
|
Timepoint(s) of evaluation of this end point: wk 1-8
|
Secondary ID(s)
|
2011-005872-41-SE
|
QTZ-EC-0004
|
Source(s) of Monetary Support
|
Astellas Pharma Europe Ltd.
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|