Pregabalin in CIPN
2019년 4월 25일 업데이트: simon.haroutounian, Washington University School of Medicine
Investigation of Somatosensory Predictors of Response to Pregabalin in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN)
The investigators seek to investigate certain patient characteristics that would predict the response to a currently approved analgesic, pregabalin, in patients with chronic pain due to nerve damage caused by chemotherapy.
Patients with this painful condition, called chemotherapy-induced peripheral neuropathy (CIPN) have a current or recent history of chemotherapy with particular chemotherapy agents called taxanes or oxaliplatin.
The investigators will recruit potential subjects from both the Siteman Cancer Center and the Washington University Pain Management Center.
Those patients who meet the inclusion and satisfy the exclusion criteria will be enrolled.
Subjects will undergo mechanical and thermal sensitivity testing on their extremities, will provide quality of life information by completing questionnaires and will receive pregabalin followed by placebo, or placebo followed by pregabalin [crossover design] in order to assess how well the sensory tests predict the analgesic effect of pregabalin (compared to placebo).
연구 개요
연구 유형
중재적
등록 (실제)
26
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine/Barnes Jewish Hospital
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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:
- Age >18
- Distal symmetric pain distribution (both feet, with or without pain in hands).
- The pain appeared during or up to 12 weeks after treatment with oxaliplatin, paclitaxel, docetaxel or any combination of these.
- Score of 4 or more on DN4 (Douleur Neuropathique 4) neuropathic pain questionnaire
- Pain duration > 2 months.
- Patient report of average daily pain intensity in the last week >3 on 0-10 Numerical Rating Scale (NRS).
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation.
- Able and willing to sign an IRB-approved written informed consent.
Exclusion Criteria:
- Hypersensitivity to pregabalin.
- Current treatment with pregabalin.
- Current treatment with a vinca alkaloid (e.g. vincristine, vinblastine), or CIPN that may be associated with previous treatment with a vinca alkaloid.
- History of diabetes mellitus or a neurological disorder with any previous signs of distal symmetric polyneuropathy.
- Moderate to severe renal failure (Creatinine clearance < 30mL/min, by Cockcroft-Gault formula).
- ALT (alanine aminotransferase) or AST (aspartate aminotransferase ) > 3 times the upper limit of normal.
- Planned surgeries or radiation treatment within 10 weeks following study inclusion.
- Inability to complete pain self-report.
- Pregnancy or lactation
- Patients with seizure disorders treated with anticonvulsants
- Current participation in a trial with another investigational agent.
Concomitant medication as follows:
- Subjects treated with gabapentin or other anticonvulsant for neuropathic pain will be required to taper the medication and discontinue for at least 2 weeks prior to study initiation.
- Patients on antidepressant treatment for pain or depression (TCAs, SSRI, SNRIs etc. will be allowed to continue their medications provided they have been on a stable dose for at least 4 weeks before study initiation. No dose regimen changes of antidepressants will be allowed during the study period.
- Patients on around-the clock opioid treatment (including tramadol) will be allowed to continue their medication provided they have been on a stable dose for at least 4 weeks before study initiation. The maximum allowed dose of opioid will be equivalent to 60mg oral morphine sulphate. Patients with higher doses will be required to taper down their opioid dose to maximum 60mg oral morphine equivalent, and continue on stable dose for 4 weeks before enrollment in the study. Short-acting opioids for painful CIPN treatment will not be allowed.
- Treatment with non-steroidal anti-inflammatory drugs (NSAIDs) will be discontinued at least 2 weeks before study initiation. However, low-dose aspirin (≤325mg/day) will be allowed.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Pregabalin
Pregabalin administered for 4 weeks, titrated to highest tolerated dose up to 600 mg/day.
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Anticonvulsant
다른 이름들:
Identical, matching inactive substance
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위약 비교기: Placebo
Identical, matching inactive substance administered for 4 weeks following the same dosing regimen.
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Anticonvulsant
다른 이름들:
Identical, matching inactive substance
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Spontaneous Pain Intensity as a Function of Baseline MPT
기간: Baseline to week 4
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Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at the end of 4-week treatment.
The slopes (Pearson coefficients) of the correlation obtained from pregabalin vs. placebo will be compared.
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Baseline to week 4
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Absolute Change in Pain Intensity, Measured on 0-10 Numerical Rating Scale (NRS)
기간: Baseline to week 4
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Absolute change in pain intensity on 0-10 numerical rating scale (NRS) from baseline to 4 weeks with pregabalin vs. placebo NRS: 0= no pain, 10= worst pain
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Baseline to week 4
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Change in NPSI Outcomes
기간: Baseline to week 4
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Change from baseline to week 4 in total NPSI (Neuropathic Pain Symptom Inventory) score The total NPSI score is comprised by adding 5 sub-scores (Burning pain, Pressing pain, Paroxysmal pain, Evoked pain, and Paresthesia/Dysesthesia) and is expressed on a 0-100 scale; 0-minimum (least), and 100 maximum (worst) score
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Baseline to week 4
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Change in BPI Outcomes (SEVERITY)
기간: Baseline to week 4
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Change from baseline to week 4 in BPI (Brief Pain Inventory) pain severity severity score BPI severity score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain severity
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Baseline to week 4
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Change in Sleep Problem Index (SPI) Outcomes
기간: Baseline to week 4
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Change from baseline to week 4 in SPI (Sleep Problem Index) score, on 0-100 scale, where 0= best (least) score, and 100= maximum (worst) score
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Baseline to week 4
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Change in BPI Outcomes (INTERFERENCE)
기간: baseline to week 4
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Change from baseline to week 4 in BPI (Brief Pain Inventory) pain interference score BPI interference score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain interference
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baseline to week 4
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Number of Patients With Significant Pain Reduction
기간: Baseline to week 4
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Number of patients who experienced 50% or more reduction in average daily pain (on 0-10 NRS, Numerical Rating Scale, where 0=least pain, 10=worst pain)
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Baseline to week 4
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Simon Haroutounian, PhD, Washington University School of Medicine
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 4월 1일
기본 완료 (실제)
2018년 4월 2일
연구 완료 (실제)
2018년 4월 2일
연구 등록 날짜
최초 제출
2015년 3월 4일
QC 기준을 충족하는 최초 제출
2015년 3월 16일
처음 게시됨 (추정)
2015년 3월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 5월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 4월 25일
마지막으로 확인됨
2019년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 201501067
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