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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01713426
• Date of registration: 22/10/2012
• Prospective Registration: No
• Primary sponsor: Astellas Pharma Europe Ltd.
• Public title: A Study to Compare QUTENZA With Pregabalin for the Treatment of Peripheral Neuropathic Pain (PNP) After 8 Weeks of Treatment ELEVATE
• Scientific title: Qutenza Versus Pregabalin in Subjects With Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability Study
• Date of first enrolment: July 11, 2012
• Target sample size: 568
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01713426
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Armenia, Austria, Belarus, Belgium, Bulgaria, Czech Republic, Czechia, Finland, France, Georgia, Germany, Greece, Hungary, Italy, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, Spain, Sweden, Turkey, United Kingdom

Contacts

• Name: Clinical Study Manager
• Affiliation: Astellas Pharma Europe Ltd.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Nerve Injury (PNI)

Postherpetic Neuralgia (PHN)

Non-diabetic Painful Peripheral Polyneuropathy

Intervention(s)

Drug: Qutenza

Drug: Pregabalin

Primary Outcome(s)

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]

Secondary Outcome(s)

Change in intensity and area of allodynia [Time Frame: Baseline to Week 8]

Changes in sensory symptoms [Time Frame: Baseline to Week 8]

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]

Reduction in pain [Time Frame: Baseline to Week 8]

Tolerability (Assessed by the number, severity and duration of ADRs) [Time Frame: Baseline to Week 8]

Change in the Medical Outcomes Study (MOS) 6-Item Cognitive Functioning Scale [Time Frame: Baseline to Week 8]

Proportion of subjects in each arm who achieve "optimal Therapeutic effect" [Time Frame: Baseline and week 8]

Change in the EQ-5D-5L (Euroqol-5 dimensions-5 levels) total score [Time Frame: Baseline to Week 8]

MOS - Sleep Scale [Time Frame: Baseline to Weeks 4 and 8]

Time to onset of pain relief (in days) [Time Frame: Up to 8 weeks]

Time to reach optimal maintenance dose for pregabalin [Time Frame: Baseline to Week 8]

Healthcare Resource use [Time Frame: Baseline to Week 8]

Overall subject status using Patient Global Impression of Change (PGIC) questionnaire [Time Frame: At Weeks 4 and 8]

Treatment satisfaction [Time Frame: Baseline to Weeks 4 and 8]

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]

Absolute and percent change in "average pain for the past 24 hours" [Time Frame: Baseline to Week 8]

Treatment satisfaction - continuance of treatment [Time Frame: Week 8]

Secondary ID(s)

2011-005872-41

QTZ-EC-0004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors