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A Study of Efficacy and Safety of Qutenza in Patients With Post-operative Peripheral Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT02171182
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma s.r.o. )

Study Description
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Brief Summary:
The aim of this study is to monitor the effectiveness and used dosage of the 8% capsaicin patch in real-life clinical practice in the treatment of post-operative neuropathic pain.

Condition or disease Intervention/treatment
Post-operative Peripheral Neuropathic Pain Drug: Qutenza

Study Design
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Study Type : Observational
Actual Enrollment : 319 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional Post-registration Clinical Study of Efficacy and Safety of Qutenza in Patients With Post-operative Peripheral Neuropathic Pain
Study Start Date : January 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Groups and Cohorts
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Group/Cohort Intervention/treatment
Qutenza patients w/ post-operative peripheral neuropathic pain Drug: Qutenza
capsaicin patch
Other Names:
  • NGX-4010,
  • A0805,
  • Capsaicin


Outcome Measures
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Primary Outcome Measures :
  1. Percentage rate of responders [ Time Frame: Baseline, Week 13 ]
    at least 30% decrease in pain intensity as compared to the baseline


Secondary Outcome Measures :
  1. Basic demographic parameters [ Time Frame: Baseline ]
    age, gender, history of the disease, other diagnoses

  2. Previous treatment of neuropathy [ Time Frame: Baseline ]
    type of treatment, dosage, combination, treatment line number

  3. Reason for a change in the therapy [ Time Frame: Baseline ]
  4. Dose [ Time Frame: Baseline, Week 13 and Week 26 ]
    number of patches, area of application and frequency of treatment with 8% capsaicin

  5. Size of the area affected by neuropathic pain [ Time Frame: Baseline, Week 13 and Week 26 ]
  6. Concomitant neuropathic medication [ Time Frame: Baseline, Week 13 and Week 26 ]
  7. Efficacy of treatment [ Time Frame: Baseline, Week 8, Week 13 and Week 26 ]
    changes in NPRS score between weeks 0 and week 8, week 13 and week 26

  8. Quality of life questionnaire (EQ-5D) [ Time Frame: Baseline, Week 8, Week 13 and Week 26 ]
  9. Consumption of rescue analgesic medication [ Time Frame: Baseline, Week 8, Week 13 and Week 26 ]
  10. Consumption of additional medical care for neuropathic pain [ Time Frame: Baseline, Week 8, Week 13 and Week 26 ]
    extra visits, hospitalisation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with post-operative peripheral neuropathic pain
Criteria

Inclusion Criteria:

  • diagnosed peripheral post-operative neuropathic pain

Exclusion Criteria:

  • hypersensitivity to capsaicin
  • pregnancy
  • diabetes mellitus
  • treatment of face
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02171182


Locations
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Sponsors and Collaborators
Astellas Pharma s.r.o.
Investigators
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Study Director: Medical and Scientific Affairs manager Astellas Pharma s.r.o.
More Information
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Responsible Party: Astellas Pharma s.r.o.
ClinicalTrials.gov Identifier: NCT02171182    
Other Study ID Numbers: 0805-MA-1001
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Astellas Pharma Inc ( Astellas Pharma s.r.o. ):
Qutenza
8% capsaicin patch
Non-interventional
 Post-operative peripheral neuropathic pain
Observational
Czech Republic
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
 Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs