Safety and Effectiveness of Repeated Administration of QUTENZA Patches for Treatment of Pain Caused by Nerve Damage (STRIDE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01252160
First received: December 1, 2010
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

In this study all patients will be treated with the same medicine, the QUTENZA patch. Subjects will receive up to 6 QUTENZA patch applications over 12 months.


Condition Intervention Phase
Neuralgia, Postherpetic
Drug: QUTENZA
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pain

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Adverse events (AEs) [ Time Frame: Throughout the study up to 65 weeks ] [ Designated as safety issue: Yes ]
  • Serious adverse events (SAEs) [ Time Frame: Throughout the study up to 65 weeks ] [ Designated as safety issue: Yes ]
  • Treatment-emergent adverse events [ Time Frame: Throughout the study up to 65 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of subjects who prematurely terminate from the study due to an AE [ Time Frame: Throughout the study up to 65 weeks ] [ Designated as safety issue: Yes ]
  • Change in Sensory function [ Time Frame: All visits throughout the study up to 65 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Use of concomitant pain medications following each patch application [ Time Frame: Throughout the study up to 65 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Vital signs [ Time Frame: All visits throughout the study up to 65 weeks ] [ Designated as safety issue: No ]
  • Dermal assessment score [ Time Frame: All visits throughout the study up to 65 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects completing at least 90% of the intended patch application duration [ Time Frame: All visits throughout the study up to 65 weeks ] [ Designated as safety issue: No ]
  • Neurological assessment [ Time Frame: All visits throughout the study up to 65 weeks ] [ Designated as safety issue: No ]
  • Brief Pain Inventory (BPI) [ Time Frame: Throughout the study up to 65 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: All visits throughout the study except the first patch application visit up to 65 weeks ] [ Designated as safety issue: No ]
  • European Quality of life questionnaire in 5 Dimensions (EQ5D) [ Time Frame: All visits throughout the study except the screening visit and unscheduled visits up to 65 weeks ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Score (HADS) [ Time Frame: All visits throughout the study except the screening visit and unscheduled visits up to 65 weeks ] [ Designated as safety issue: No ]
  • Work Productivity and Activity Impairment Questionnaire: Neuropathic Pain (WPAI:NP) [ Time Frame: All visits throughout the study except the screening visit and unscheduled visits up to 65 weeks ] [ Designated as safety issue: No ]
  • Self-Assessment of Treatment (SAT) questionnaire [ Time Frame: At the Week 26 visit and planned or early termination visit no later than week 65 ] [ Designated as safety issue: No ]
  • Change in use of concomitant pain medications [ Time Frame: Throughout the study up to 65 weeks ] [ Designated as safety issue: No ]

Enrollment: 306
Study Start Date: October 2010
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

Detailed Description:

The rationale for the current study is to evaluate the safety of repeated QUTENZA applications, including the effect of QUTENZA on sensory function in subjects diagnosed with different types of Peripheral Neuropathic Pain (PNP). In order to adequately assess the long-term safety QUTENZA in well defined patient populations the current study will enroll a minimum of 100 patients each with HIV-Associated Neuropathy (HIV-AN) and Postherpetic Neuralgia (PHN).

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Common Inclusion Criteria:

  • Be in good health as determined by the investigator
  • Average pain score >=4 during screening period (using the average reported pain from the Brief Pain Inventory [BPI])
  • Intact, non-irritated, dry skin over the painful area(s) to be treated
  • 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
  • Be willing and able to comply with protocol requirements for the duration of study participation

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 PNP 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): Presence of HIV-AN existing for a minimum of 3 months, confirmed using the Brief Peripheral Neuropathy Screen (BPNS) at the time of study entry
  • 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 criteria (e.g. quantitative sensory testing) or skin biopsy

      1. Neuropathy exclusively or predominantly affecting A-δ (small myelinated) and nociceptive C (unmyelinated) nerve fibres
      2. Loss of pinprick and temperature sensation in feet
  • Or

    • Other Peripheral Neuropathic Pain (PNP): Adequately characterized PNP based on clinical history and examination existing at the time of screening

Exclusion Criteria:

  • Any prior receipt of QUTENZA open label or blinded study patches
  • 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
  • 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 oxycodone or other analgesic, as judged by the investigator
  • Active substance abuse or history of chronic substance abuse within 1 year prior to enrolment or prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator
  • Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics, steroids or capsaicin products on the painful areas within 7 days preceding the first patch application visit
  • Current use of any investigational agent (excluding antiretrovirals in Phase 3 evaluation to treat HIV infection)
  • 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
  • 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
  • Past or current history of Type I or Type II diabetes mellitus
  • Current psychotic disorders
  • Clinically significant abnormal ECG at screening
  • Hypersensitivity to capsaicin (i.e., chilli peppers or Over-the-counter [OTC] capsaicin products), any QUTENZA excipients, local anesthetics, oxycodone, hydrocodone, or adhesives
  • 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
  • Significant pain of an aetiology other than painful HIV-AN, PHN, PNI, ISNN or other adequately characterized PNP for example, compression-related neuropathies (e.g., spinal stenosis), fibromyalgia or arthritis
  • Posttraumatic neuropathic pain due to Complex Regional Pain Syndrome (CRPS, Type I)
  • 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)
  • 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
  • Planned elective surgery during the trial
  • Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes
  • 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: NCT01252160

  Show 64 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Europe Ltd.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01252160     History of Changes
Other Study ID Numbers: E05-CL-3001, 2009-016457-18
Study First Received: December 1, 2010
Last Updated: March 28, 2014
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Ministry of Health
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Neuralgia, Postherpetic
QUTENZA

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Capsaicin
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 15, 2014