A Study to Compare QUTENZA With Pregabalin for the Treatment of Peripheral Neuropathic Pain (PNP) After 8 Weeks of Treatment (ELEVATE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier:
NCT01713426
First received: October 22, 2012
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

This study is comparing the efficacy and tolerability of Qutenza with that of pregabalin in patients suffering from peripheral neuropathic pain. Treatment allocation will be to one of these treatments and the duration of the study will be about 10 weeks (assuming that from screening to treatment allocation takes 2 weeks). Participants will be asked to complete questionnaires about various aspects relating to their condition throughout the study.

This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve Injury or Non Diabetic peripheral polyneuropathy.


Condition Intervention Phase
Postherpetic Neuralgia (PHN)
Peripheral Nerve Injury (PNI)
Non-diabetic Painful Peripheral Polyneuropathy
Drug: Qutenza
Drug: Pregabalin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Qutenza Versus Pregabalin in Subjects With Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability Study

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Proportion of subjects in each arm who achieve at least 30% decrease in the "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score from baseline to week 8 [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects in each arm who achieve "optimal Therapeutic effect" [ Time Frame: Baseline and week 8 ] [ Designated as safety issue: No ]

    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" [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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" [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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" [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: At Weeks 4 and 8 ] [ Designated as safety issue: No ]
  • Change in the Medical Outcomes Study (MOS) 6-Item Cognitive Functioning Scale [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • MOS - Sleep Scale [ Time Frame: Baseline to Weeks 4 and 8 ] [ Designated as safety issue: No ]
  • Change in the EQ-5D-5L (Euroqol-5 dimensions-5 levels) total score [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Treatment satisfaction [ Time Frame: Baseline to Weeks 4 and 8 ] [ Designated as safety issue: No ]

    As assessed by:

    • Proportion of subjects who discontinue study drug or withdraw from the study due to either a lack of efficacy or tolerability
    • Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire at Week 4 and Week 8

  • Treatment satisfaction - continuance of treatment [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    As assessed by willingness to continue treatment at Week 8

  • Time to reach optimal maintenance dose for pregabalin [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Healthcare Resource use [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    Number of contacts with health professionals

  • Tolerability (Assessed by the number, severity and duration of ADRs) [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Changes in sensory symptoms [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    Assessed using Neuropathic Pain Symptom Inventory (NPSI) scores

  • Reduction in pain [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
    By the pattern of sensory symptoms as defined using NPSI scores at baseline.


Enrollment: 568
Study Start Date: July 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Qutenza Drug: Qutenza
Cutaneous patch
Other Name: Capsaicin
Active Comparator: Pregabalin Drug: Pregabalin
Oral capsule

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Documented diagnosis of probable or definite PNP
  • 2. Localized and well-defined area of PNP, suitable for treatment with QUTENZA
  • 3. Documented diagnosis at the Baseline Visit of either:

    • Postherpetic neuralgia (PHN) with pain persisting at least 6 months since shingles vesicle crusting
    • Peripheral nerve injury (PNI) including post-surgical or post-traumatic neuropathic pain, persisting for a minimum of 3 months
    • 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
  • 4. 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
  • 5. Intact, non-irritated, dry skin over the painful area(s) to be treated
  • 6. Is either:

    • Naïve to treatment with pregabalin and gabapentin, OR
    • In the opinion of the investigator, has not received an adequate trial of treatment with pregabalin or gabapentin
  • 7. Subject is willing to receive pregabalin or QUTENZA as part of the trial
  • 8. 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713426

  Show 98 Study Locations
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier: NCT01713426     History of Changes
Other Study ID Numbers: QTZ-EC-0004, 2011-005872-41
Study First Received: October 22, 2012
Last Updated: September 4, 2014
Health Authority: Armenia: Ministry of Health
Austria: Ministry of Health
Belarus: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Ministry of Health
Georgia: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health and Welfare
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Italy: National Institute of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Agency for Medicines and Medical Devices
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Post herpetic neuralgia
Peripheral Neuropathic Pain
Qutenza
Pregabalin
NGX-4010

Additional relevant MeSH terms:
Neuralgia
Polyneuropathies
Neuralgia, Postherpetic
Peripheral Nerve Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Trauma, Nervous System
Wounds and Injuries
Pregabalin
Capsaicin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on September 30, 2014