Observation of the Use of QUTENZA™ in Standard Clinical Practice (ASCEND)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier:
NCT01737294
First received: October 22, 2012
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

This non-interventional study will evaluate the efficacy, tolerability, health related quality of life and use of health resources associated with QUTENZA treatment when QUTENZA is used in standard clinical practice.

The patient's primary diagnosis of peripheral neuropathic pain (PNP) will be classified into subtypes: post-herpetic neuralgia (PHN); HIV-associated neuropathy (HIV-AN); neuropathic back pain; cancer-related neuropathic pain; post-operative & post-traumatic neuropathic pain; and 'other' neuropathies.


Condition Intervention
Peripheral Neuropathic Pain
Drug: Qutenza exposure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of QUTENZA™ in Standard Clinical Practice: a Phase IV, Multicentre, European Non-interventional Study

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Percent change in average pain NPRS (Numeric Pain Rating Scale) scores [ Time Frame: From Baseline to mean of all scores recorded between week 2 and week 8 following first treatment ] [ Designated as safety issue: No ]
  • Time to retreatment [ Time Frame: Between 1st & 2nd treatments (up to a maximum of 24 months) ] [ Designated as safety issue: No ]
    From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)


Secondary Outcome Measures:
  • Proportion of patients achieving 30% decrease in average pain NPRS score [ Time Frame: From Baseline to mean of all scores recorded between weeks 2 & 8 following 1st treatment ] [ Designated as safety issue: No ]
  • Proportion of patients achieving 50% decrease in average pain NPRS score [ Time Frame: From Baseline to mean of all scores recorded between weeks 2 & 8 following 1st treatment ] [ Designated as safety issue: No ]
  • Percent change in "average pain" NPRS score [ Time Frame: From baseline to mean of all scores between Week 2 and Week 8 and Weeks 2 and Week 12 following retreatment(s) ] [ Designated as safety issue: No ]
    From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)

  • Proportion of patients achieving a 30% decrease in their "average pain" NPRS score (maintenance response) [ Time Frame: From Baseline to the mean of all scores between week 2 and week 8 and between week 2 and week 12 following retreatment(s) ] [ Designated as safety issue: No ]
    From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)

  • Proportion of patients achieving a 50% decrease in their "average pain" NPRS score (maintenance response) [ Time Frame: From Baseline to the mean of all scores between week 2 and week 8 and between week 2 and week 12 following retreatment(s) ] [ Designated as safety issue: No ]
    From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)

  • Absolute change in "average pain" NPRS score [ Time Frame: From baseline to the average of pain scores assessed between Weeks 2 & 12 following 1st and subsequent treatment(s) ] [ Designated as safety issue: No ]
    From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)

  • Proportion of patients achieving a 2-point absolute decrease in their "average pain" NPRS score [ Time Frame: From baseline to the average of pain scores assessed between Weeks 2 & 12 following 1st and subsequent treatment(s) ] [ Designated as safety issue: No ]
    From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)

  • Mean "Average pain" NPRS score [ Time Frame: At each time point following 1st and subsequent treatment(s) (up to a maximum of 24 months) ] [ Designated as safety issue: No ]
    From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)

  • Time (in days) between successive retreatments [ Time Frame: Between successive retreatments (up to a maximum of 24 months) ] [ Designated as safety issue: No ]
    From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)

  • Number of QUTENZA patches used with each treatment [ Time Frame: Day 1 of each treatment ] [ Designated as safety issue: No ]
  • Relative change in treatment area size [ Time Frame: At first treatment and each retreatment (up to a maximum of 24 months) ] [ Designated as safety issue: No ]
    From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)

  • Change in concomitant pain medications [ Time Frame: From baseline to End of Study (up to 24 months) ] [ Designated as safety issue: No ]
    Percentage remaining on opioids, anticonvulsants, antidepressants

  • Change in health-related quality of life [ Time Frame: From baseline to End of Study (up to 24 months) ] [ Designated as safety issue: No ]
    Measured by the EQ-5D (Euroqol-5 dimensions) index

  • Change in health resource use [ Time Frame: From baseline to End of Study (up to 24 months) ] [ Designated as safety issue: No ]
    Number of contacts with health professionals in prior 4 weeks

  • Patient Global Impression of Change [ Time Frame: At each follow-up after 1st and subsequent treatment(s) (up to a maximum of 24 months) ] [ Designated as safety issue: No ]
    Percentage reporting any degree of improvement. Week 2 after 1st Treatment to End of Study

  • Patient Self Assessment of Treatment [ Time Frame: At 12 weeks, 6 months, 9 months, and 12 months after 1st and subsequent retreatment(s) ] [ Designated as safety issue: No ]
    Week 2 after 1st Treatment to End of Study

  • Change in Work Productivity and Activity Impairment scores [ Time Frame: Baseline, week 12, 6 months, 9 months, and 12 months after 1st and subsequent treatment(s) ] [ Designated as safety issue: No ]
    Week 2 after 1st Treatment to End of Study

  • Percentage of patients requiring rescue measures during and after treatment with QUTENZA [ Time Frame: From Baseline to End of Study (up to 24 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: February 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment with QUTENZA
Patients with Peripheral Neuropathic Pain
Drug: Qutenza exposure
Cutaneous patch
Other Name: Capsaicin

Detailed Description:

A detailed medical history will be taken, with particular emphasis on the primary PNP diagnosis. In addition to all current neuropathic pain medications, all previous therapies (pharmacological and surgical) for PNP from the point of primary diagnosis will be documented.

QUTENZA treatments may be repeated up to every 90 days, in line with the Summary of Product Characteristics document (SPC) as determined by the persistence or return of pain.

Patients who have not required treatment for 365 days or longer may re-enter a treatment cycle if their treating physician decides to retreat them with QUTENZA in the course of standard clinical management.

The duration of participation for each patient will be at least 12 months following first QUTENZA treatment.

Short questionnaires will be completed by the investigator whilst in contact with the patient (either in person or by telephone) at the following time points: 1) Screening prior to the first QUTENZA treatment; 2) at each QUTENZA treatment visit; 3) 2 weeks, 8 weeks following the first QUTENZA treatment 4) 12 weeks following each QUTENZA treatment; 5) any additional contact with the patient outside the protocol schedule.

For patients not returning for retreatment with QUTENZA within any of 6 months, 9 months, and 1 year of their previous QUTENZA treatment further follow-up questionnaires will be completed.

End of study (EoS) is defined as one year after the last patient enrolled receives their first QUTENZA treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients receiving QUTENZA for PNP in routine clinical practice

Criteria

Inclusion Criteria:

  • 1. The investigator has decided to treat the patient with QUTENZA as part of provision of standard care for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain
  • 2. The patient is willing and able to comply with protocol requirements for the duration of study participation

Exclusion Criteria:

  • 1. The neuropathic painful areas are located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes
  • 2. The patient has a history of Type I or Type II diabetes mellitus
  • 3. The patient has a diagnosis of any major psychiatric disorder or evidence of cognitive impairment including dementia that, in the opinion of the investigator, may interfere with patient's ability to complete study evaluations
  • 4. The patient has received any prior treatment with QUTENZA patches, including blinded patches administered as part of a clinical trial
  • 5. The patient has hypersensitivity to capsaicin (i.e. chilli peppers or over-the-counter [OTC] capsaicin products), any QUTENZA excipients or adhesives, or local anesthetics
  • 6. The patient has participated in any other clinical study or received an investigational drug within 30 days prior to Screening Visit
  • 7. The patient currently engages in any active substance abuse or has a history of chronic substance abuse within 1 year prior to the Screening Visit; or any prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator
  • 8. The patient, in the opinion of the investigator, is not suitable to participate in this NIS for any reason
  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: NCT01737294

Contacts
Contact: Late Phase Clinical Development & Operations +31 (0)71 54 55 878 contact@astellas.com

  Show 65 Study Locations
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
Study Director: Company Medical Expert Astellas Pharma Europe Ltd.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
ClinicalTrials.gov Identifier: NCT01737294     History of Changes
Other Study ID Numbers: QTZ-EC-0003
Study First Received: October 22, 2012
Last Updated: March 18, 2014
Health Authority: Hungary: Scientific and Medical Research Council Ethics Committee
Italy: Ethics Committee
Greece: Ethics Committee
Portugal: Health Ethic Committee
United Kingdom: Research Ethics Committee
Spain: Departament de Salut de la Generalitat de Catalunya
Switzerland: Ethikkommission
Austria: Agency for Health and Food Safety

Keywords provided by Astellas Pharma Inc:
Phase IV
Peripheral Neuropathic Pain
QUTENZA

Additional relevant MeSH terms:
Neuralgia
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 30, 2014