Comparison of efficacy and safety of Qutenza vs Lyrica

• Conditions: Patients who have a documented diagnosis of probable or definite Peripheral Neuropathic Pain; MedDRA version: 16.0Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-005872-41-BG
• Lead Sponsor: Astellas Pharma Europe Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-21
• Last Update Posted: 10 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 526

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified