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Completed

NCT Number: NCT02171182

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

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.

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Key information

Conditions

Post-operative Peripheral Neuropathic Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site CZ42019 Hospital, Benešov, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosed peripheral post-operative neuropathic pain

Exclusion criteria

  • hypersensitivity to capsaicin
  • pregnancy
  • diabetes mellitus
  • treatment of face

Treatment and study plan

Qutenza

Drug

capsaicin patch

Other names: NGX-4010,, A0805,, Capsaicin

Primary outcomes

  1. Percentage rate of responders

    Time frame: Baseline, Week 13

    at least 30% decrease in pain intensity as compared to the baseline

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma s.r.o.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 24, 2014
Registry last updated
Feb 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.