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Novel Treatment Option for Neuropathic Pain (NoTOPain)

2016년 11월 7일 업데이트: Sorlandet Hospital HF

A Randomized, Cross-over, Placebo-controlled, Double-blind, Single-center, Phase II Study of Cetuximab in Patients With Treatment-refractory, Non-malignant Severe Chronic Neuropathic Pain

The purpose of this study is to determine whether the EGFR-inhibitor cetuximab is better than placebo for the treatment of neuropathic pain.

연구 개요

연구 유형

중재적

등록 (실제)

15

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Kristiansand, 노르웨이, 4604
        • Center for Cancer Treatment, Sorlandet Hospital HF

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Signed informed consent and anticipated compliance.
  • Pain defined as "definite" neuropathic pain, according to the Special Interest Group on Neuropathic Pain guidelines or defined as "probable" NP, according to the guidelines, if the confirmatory test was a positive diagnostic test. Complex regional pain syndrome can be included despite lack of an offending lesion, as long as the "Budapest criteria" are fulfilled
  • Neuropathic Pain associated with compressive nerve states (including failed surgery) or CRPS (according to the "Budapest criteria")
  • PainDETECT score of at least 13 with average pain intensity of at least 6 /10 over the last four weeks. In addition, a painDETECT pattern indicating that the underlying neuropathic pain is constantly present.
  • Worst pain intensity higher than 6 for five of seven days during the screening phase, according to Brif Pain Inventory.
  • The patient should be able to distinguish between the neuropathic pain and other pain conditions, including elements of nociceptive pain caused by the same disease process.
  • Neuropathic pain duration of between six and thirty months, deemed chronic and likely to be irreversible by clinical history and findings.
  • No new or increased neuropathic pain treatment for the last four weeks.
  • Standard medical treatments for the patients' underlying condition or neuropathic pain must have been considered or tried and must, according to the opinion of the referring or a consulted pain specialist, be judged to be inappropriate or of insufficient potential efficacy.
  • Referring physician agreement to follow up the patient after study completion according to the best possible and available pain treatment and care.
  • Women of childbearing potential and men must use an acceptable method of contraception throughout the study, and for 30 days after the last study drug administration.
  • Negative pregnancy test within 7 days before each treatment period where appropriate.
  • White blood cell count ≥ 3 × 109 with neutrophils ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L and hemoglobin ≥ 6.21 mmol/L (10 g/dL). Total bilirubin ≤ 1.5 × upper limit of reference range and AST and ALT ≤ 2.5 × upper limit of reference range within the last 28 days before inclusion.
  • Aged 18 or above

Exclusion Criteria:

  • Neuropathic pain origin in the central nervous system.
  • Phantom limb pain or a significant component of nociceptive pain.
  • Ascending distal small fiber peripheral neuropathy.
  • Patients primarily experiencing pain 'attacks', i.e. pattern of neuropathic pain depicted in picture 3 of the painDETECT.
  • Other pain state that may interfere with evaluation of the studied neuropathic pain condition.
  • Any underlying medical or psychiatric condition, clinical disorder or laboratory finding, which in the opinion of the investigator may interfere with study objectives.
  • Uncontrolled or unstable diabetes.
  • Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV), unstable angina pectoris, history of myocardial infarction within the last twelve months, significant arrhythmias
  • Severe cerebrovascular disease during the six months prior to inclusion.
  • Active and ongoing eye and skin disorders or newly diagnosed gastric ulcer that may interfere with the study treatment.
  • History of allergic reaction to any of the study treatment components, red meat or tick bites.
  • Previous treatment with any EGFR-pathway inhibitor.
  • Women who are pregnant or breastfeeding.
  • Participation in another clinical trial within the past 90 days.
  • Use of any investigational agent within 90 days prior to day 1 of study drug.
  • Known drug abuse/alcohol abuse, legal incapacity or limited legal capacity or any other reason that, in the opinion of the investigator precludes the subject from participating.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: A: active drug first
Cetuximab in treatment period 1, placebo in treatment period 2, and open-label cetuximab in treatment period 3.
Randomized cross-over between cetuximab and placebo
다른 이름들:
  • 얼비툭스
Randomized cross-over between cetuximab and placebo
실험적: B: placebo first
Placebo in treatment period 1, cetuximab in treatment period 2, and open-label cetuximab in treatment period 3.
Randomized cross-over between cetuximab and placebo
다른 이름들:
  • 얼비툭스
Randomized cross-over between cetuximab and placebo

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Change in average neuropathic pain score using an 11-point numeric rating scale.
기간: Days 4-8 after each infusion of cetuximab and placebo
Days 4-8 after each infusion of cetuximab and placebo

2차 결과 측정

결과 측정
기간
Comparison of frequency, in all patients on active treatment of at least a 30% reduction of average neuropathic pain score using an 11-point numeric rating scale.
기간: Days 4-8 after each infusion of cetuximab and placebo
Days 4-8 after each infusion of cetuximab and placebo
Comparison of frequency in all patients on active treatment of at least a 50% reduction of average neuropathic pain score using an 11-point numeric rating scale.
기간: Days 4-8 after each infusion of cetuximab and placebo
Days 4-8 after each infusion of cetuximab and placebo
Comparison of change in average worst neuropathic pain score using an 11-point numeric rating scale.
기간: Days 4-8 after each infusion of cetuximab and placebo
Days 4-8 after each infusion of cetuximab and placebo
Comparison of frequency, in all patients on active treatment of at least a 30% reduction of average worst neuropathic pain score using an 11-point numeric rating scale.
기간: Days 4-8 after each infusion of cetuximab and placebo
Days 4-8 after each infusion of cetuximab and placebo
Comparison of frequency in all patients on active treatment of at least a 50% reduction of average worst neuropathic pain score using an 11-point numeric rating scale.
기간: Days 4-8 after each infusion of cetuximab and placebo
Days 4-8 after each infusion of cetuximab and placebo
Patient Global Impression of Change.
기간: 7 days after each infusion.
7 days after each infusion.
Brief Pain Iinventory (short form) interference scores, comparing cetuximab to the placebo.
기간: Days 4-8 after each infusion during treatment periods 1 and 2.
Days 4-8 after each infusion during treatment periods 1 and 2.
Brief Pain Iinventory (short form) total scores, comparing cetuximab to the placebo.
기간: Days 4-8 after each infusion during treatment periods 1 and 2.
Days 4-8 after each infusion during treatment periods 1 and 2.
2-hourly waking time 11-point numeric rating scale (item #6 from the Brief Pain Inventory) in the first 24 hours and daily thereafter.
기간: 2-hourly in first 24 hours after infusion and daily thereafter until end of study (day 86).
2-hourly in first 24 hours after infusion and daily thereafter until end of study (day 86).
Number of AE and SAE recording
기간: From signing informed consent (within 28 days prior to first study treatment) and until 30 days after the last study infusion.
From signing informed consent (within 28 days prior to first study treatment) and until 30 days after the last study infusion.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Christian Kersten, MD PhD, Center for Cancer Treatment, Sørlandet Hospital, Kristiansand

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2015년 10월 1일

기본 완료 (실제)

2016년 10월 1일

연구 완료 (실제)

2016년 10월 1일

연구 등록 날짜

최초 제출

2015년 6월 5일

QC 기준을 충족하는 최초 제출

2015년 7월 2일

처음 게시됨 (추정)

2015년 7월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 11월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 11월 7일

마지막으로 확인됨

2016년 11월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • SFK3 / 062202_281
  • 2015-001195-21 (EudraCT 번호)
  • 2015/618/REK sør-øst D (기타 식별자: Regional Committees for Medical and Health Research Ethics)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Cetuximab에 대한 임상 시험

3
구독하다