A study in which multiple applications of Qutenza are investigated in patients with nerve pain

• Register: EUCTR
• Last refreshed on: 26 November 2013
• Main ID: EUCTR2009-016457-18-FI
• Date of registration: 30/06/2010
• Prospective Registration: Yes
• Primary sponsor: Astellas Pharma Europe Ltd
• Public title: A study in which multiple applications of Qutenza are investigated in patients with nerve pain
• Scientific title: A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pain - STRIDE
• Date of first enrolment: 19/08/2010
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016457-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Austria, Czech Republic, Finland, France, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Slovenia, Spain, United Kingdom

Contacts

• Name: Service Desk
• Affiliation: Astellas Pharma Europe B.V.

• Name: Service Desk
• Affiliation: Astellas Pharma Europe B.V.

Key inclusion & exclusion criteria

Inclusion criteria:
Common Inclusion Criteria:
1. Male or female between 18 and 90 years of age, inclusive
2. Be in good health as determined by the investigator
3. Average pain score >=4 during screening period (using the average reported pain from the Brief Pain Inventory [BPI])
4. Intact, unbroken skin over the painful area(s) to be treated
5. All females of child bearing potential must be willing to use effective methods of birth control during the study and for 30 days following study termination
6. Be willing and able to comply with protocol requirements for the duration of study participation
7. Subject has given written informed consent

Population-specific Inclusion Criteria:
All subjects must meet one (and only one) of the Population-Specific Inclusion Criteria for PHN, HIV-AN, PNI or ISNN or have adequately characterized peripheral neuropathic pain based on clinical history and examination:

Postherpetic Neuralgia (PHN)
Prior diagnosis of PHN with pain persisting at least 3 months since shingles vesicle crusting, documented by the primary treating physician or investigator
Or
Painful HIV-Associated Neuropathy (HIV-AN)
Confirmation of HIV-AN existing for a minimum of 3 months, as assessed using the Brief Peripheral Neuropathy Screen (BPNS)
Or
Peripheral Neuropathic Injury (PNI)
Diagnosis of Post-traumatic Peripheral Neuropathic Pain syndrome, including post-surgical neuropathic pain, neuropathic pain due to peripheral nerve injury, confirmed by a qualified pain specialist and persisting for a minimum of 3 months following the traumatic event
Or
Idiopathic Small Nerve Neuropathy (ISNN)
Diagnosis of ISNN based on clinical and electrodiagnostic criteria:
Neuropathy exclusively or predominantly affecting A-d (small myelinated) and nociceptive C (unmyelinated) nerve fibres
Loss of pinprick and temperature sensation in feet
Or
Other Peripheral Neuropathic Pain (PNP)
Adequately characterized peripheral neuropathic pain based on clinical history and examination existing at the time of screening.


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 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
1. Any prior receipt of QUTENZA open label or blinded study patches
2. Use of oral or transdermal opioids exceeding a total daily dose of morphine of 80 mg/day, or equivalent; or any parenteral opioids, regardless of dose, within 7 days preceding the first patch application visit.
3. Lack of an effective pain medication strategy for the subject, such as unwillingness to use opioid analgesics during study treatment, or high tolerance to opioids precluding the ability to relieve treatment-associated discomfort with oxicodone or other analgesic, as judged by the investigator
4. Active substance abuse or history of chronic substance abuse within 1 year prior to enrolment or prior chronic substance abuse (including alcoholism) judged likely to re-occur during the study period by the investigator
5. Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anaesthetics, steroids or capsaicin products on the painful areas within 7 days preceding the first patch application visit
6. Current use of any investigational agent (excluding antiretrovirals in Phase 3 evaluation to treat HIV infection)
7. Unstable or poorly controlled hypertension or a recent history of a cardiovascular event which, in the opinion of the investigator, would put the patient at risk of adverse cardiovascular reactions related to the patch application procedure
8. Evidence of another contributing cause for peripheral neuropathy, and/or treatment within 90 days prior to screening visit with any drug that may have contributed to the sensory neuropathy
9. Past or current history of Type I or Type II diabetes mellitus
10. Current psychotic disorders
11. Clinically significant abnormal ECG at screening
12. Hypersensitivity to capsaicin (i.e., chilli peppers or Over-the-counter [OTC] capsaicin products),any QUTENZA excipients, local anaesthetics, oxycodone, hydrocodone, or adhesives
13. Significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may interfere either with the ability to complete the study or the evaluation of adverse events
14. Significant pain of an aetiology other than painful HIV-AN, PHN, PNI, ISNN or other adequately characterized peripheral neuropathic pain for example, compression-related neuropathies (e.g., spinal stenosis), fibromyalgia or arthritis
15. Posttraumatic neuropathic pain due to Complex Regional Pain Syndrome (CRPS, Type I)
16. Active malignancy or history of malignancy during the past 5 years (a history of squamous cell carcinoma or a basal cell carcinoma not involving the area to be treated is allowed)
17. 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
18. Planned elective surgery during the trial
19. Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes.
20. Female subjects of child-bearing potential with a positive serum or urine pregnancy test prior to treatment


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Peripheral Neuropathic Pain in Postherpetic Neuralgia (PHN), Painful HIV-Associated Neuropathy (HIV-AN), Peripheral Neuropathic Injury (PNI), Idiopathic Small Nerve Neuropathy (ISNN) or other Peripheral Neuropathic Pain (PNP).
MedDRA version: 14.1 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Trade Name: QUTENZA (TM)
Product Name: Qutenza
Product Code: N/A
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: CAPSAICIN
CAS Number: 404864
Current Sponsor code: N/A
Other descriptive name: CAPSAICIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 179-

Primary Outcome(s)

Primary end point(s): Adverse events, serious adverse events and treatment emergent adverse events, including the proportion of subjects who prematurely terminate from the study due to an AE

Sensory function: change from screening visit of warm, cold sharp and vibration sensations and allodynia, assessed at patch application visits, week 26 (if applicable) and the planned or early termination visit.

Secondary Objective: To assess the efficacy of repeated treatments of QUTENZA in subjects with peripheral neuropathic pain.

Main Objective: To assess the safety of repeated treatments of QUTENZA in subjects with peripheral neuropathic pain.

Timepoint(s) of evaluation of this end point: at the screening visit, at all patch application visits, at week 26 visit (if applicable), and at the planned or early termination visit.

Secondary Outcome(s)

Secondary end point(s): Secondary Safety Variables:
- Use of concomitant pain medications following each patch application
- Vital signs, including changes from baseline and before and after patch application
- The number and percentage of patients with each dermal assessment score at screening visit, study patch application visits (prior to and after patch application) and at planned or early termination visit
- The proportion of subjects completing at least 90% of the intended patch application duration
- Neurological assessment from screening visit to planned or early termination visit

Secondary Efficacy Variables
- Brief Pain Inventory (BPI) at screening visit, at every patch application visit, weekly between patch application visits and at planned or early termination visit, including changes from baseline and before and after each patch application.
- Patient Global Impression of Change (PGIC) questionnaire at patch application visits (except the first patch application visit), 4 weeks after each patch application visit, at week 26 (if applicable) and at the planned or early termination visit.
- Quality of Life (QoL) information at each study visit, and also 4 weeks after each patch application
- Self-Assessment of Treatment (SAT) questionnaire at week 26 (if applicable) and planned or early termination visit
- Change in use of concomitant pain medications from screening visit to planned or early termination visit

Timepoint(s) of evaluation of this end point: Safety:
at the screening visit, at all patch application visits, at week 26 visit (if applicable), and at the planned or early termination visit.

Efficacy:
at the screening visit, prior to any procedures relating to the painful area(s) at each study application visit, 4 weeks after each patch application visit, at the week 26 visit (if applicable) and at the planned or early termination visit.

Secondary ID(s)

E05-CL-3001

2009-016457-18-IE

Source(s) of Monetary Support

Astellas Pharma Europe Ltd