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A Study of Effectiveness and Safety of JNJ-42160443 in Patients With Diabetic Painful Neuropathy

2016년 5월 9일 업데이트: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Subjects With Diabetic Painful Neuropathy, Followed by a Double-Blind Safety Extension and an Open-Label Safety Extension

The purpose of this study is to evaluate the analgesic efficacy, safety and tolerability of multiple doses of JNJ-42160443 when administered as a single, subcutaneous injection every 28 days to patients with diabetic painful neuropathy (a disease condition in diabetic patients that affects all peripheral nerves including pain fibers, motor neurons and the autonomic nervous system).

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

This is a multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), double-blind (neither investigator nor the patient knows the treatment that the patient receives), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), dose-ranging study (study carried out at different doses) to evaluate the analgesic efficacy, safety, and tolerability of multiple doses of JNJ-42160443 in patients with neuropathic pain, followed by a double-blind safety extension and an open-label (all people know the identity of the intervention) safety extension. The study will consist of 5 sequential phases: 1) screening, 2) a 12-week double-blind efficacy, 3) a 40-week double-blind safety extension, 4) a 52-week open-label safety extension, and 5) a 26-week post-treatment/follow-up. After the screening phase, patient randomization will be stratified by current pain medication use (patients who are currently using or who are not currently using permitted pain medication). The planned doses for the double-blind efficacy phase and double blind safety extension phase are placebo, JNJ-42160443 1, 3, or 10 mg administered as a single, subcutaneous injection every 28 days. Safety assessment will include adverse events, injection site evaluations, clinical laboratory tests, electrocardiogram, vital signs, physical examinations, neurological examinations, and joint safety which will be monitored throughout the study. The total study duration (including all the 5 phases) will be approximately 131 weeks.

연구 유형

중재적

등록 (실제)

77

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 미국
    • Arkansas
      • Jonesboro, Arkansas, 미국
    • California
      • Fresno, California, 미국
      • La Jolla, California, 미국
      • Long Beach, California, 미국
      • Redondo Beach, California, 미국
      • Tustin, California, 미국
      • Walnut Creek, California, 미국
    • Florida
      • Bradenton, Florida, 미국
      • Palm Beach Gardens, Florida, 미국
    • Maryland
      • Baltimore, Maryland, 미국
    • New York
      • Albany, New York, 미국
      • Syracuse, New York, 미국
    • North Carolina
      • Winston Salem, North Carolina, 미국
      • Winston-Salem, North Carolina, 미국
    • Ohio
      • Toledo, Ohio, 미국
    • Oklahoma
      • Tulsa, Oklahoma, 미국
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국
    • South Carolina
      • Greer, South Carolina, 미국
    • Tennessee
      • Tullahoma, Tennessee, 미국
    • Texas
      • Austin, Texas, 미국
      • Houston, Texas, 미국
      • Plano, Texas, 미국
      • San Antonio, Texas, 미국
    • Washington
      • Renton, Washington, 미국

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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Chronic neuropathic pain (pain persistent for greater than 6 months) that is moderate to severe in the opinion of the investigator
  • Currently taking neuropathic pain medication limited to maximal allowed doses according to guidelines provided, but are not adequately controlled by standard of care
  • Currently not taking neuropathic pain medications because they are intolerable to, or not willing to use, standard of care
  • Mean average pain intensity score of at least 5, but less than 10, over 7 consecutive days on an 11-point numerical rating scale
  • Pain due to bilateral peripheral neuropathy caused by type 1 or type 2 diabetes mellitus
  • Required to have stable glycemic control

Exclusion Criteria:

  • Patients with severe diabetic neuropathy defined by severe autonomic dysfunction or blood pressure instability Separate pain condition (e.g., joint osteoarthritis) that is more severe than their pain due to their diagnosis of Diabetic Peripheral Neuropathy
  • Patients with evidence of another neuropathic pain not under the study, such as pain resulting from post-traumatic neuralgia, post-surgical neuropathy, complex regional pain, sensory neuropathies or pain caused by radiation, chemotherapy, alcohol, Human Immunodeficiency Virus (HIV) infection
  • Major surgeries, trauma, and non-healing wounds/ulcers within 3 months prior to study medication
  • History of severe traumatic brain injury within the past 15 years
  • Other peripheral neuropathy, parasthesia or dyesthesia or previously diagnosed neurological condition causing these symptoms not related with diabetic painful neuropathy under study

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: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: JNJ-42160443 (1 mg)
JNJ-42160443 1 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
의약품: JNJ-42160443 (1 mg)
JNJ-42160443 1 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
실험적: JNJ-42160443 (3 mg)
JNJ-42160443 3 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
의약품: JNJ-42160443 (3 mg)
JNJ-42160443 3 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
실험적: JNJ-42160443 (10 mg)
JNJ-42160443 10 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
의약품: JNJ-42160443 (10 mg)
JNJ-42160443 10 mg will be administered as a single, subcutaneous injection every 28 days for up to first 52 weeks in the blinded fashion and then every 28 days for up to an additional 52 weeks in the open-label fashion.
위약 비교기: Placebo
Placebo will be administered as a single, subcutaneous injection every 28 days for up to 52 weeks.
의약품: Placebo
Patients will receive single injection of matching placebo every 28 days for up to 52 weeks.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Average pain intensity
기간: Baseline to Week 13
The mean of the daily evening assessment of average pain intensity is measured by using 11-point numerical rating scale (NRS), where 0 = no pain and 10 = pain as bad as the patient can imagine.
Baseline to Week 13

2차 결과 측정

결과 측정
측정값 설명
기간
Pain at its worst
기간: Baseline to Week 13
The assessment of pain at its worst in the past 24 hours will be performed once daily, in the evening, using an 11-point numerical rating scale (NRS), where 0 = no pain and 10 = pain as bad as the patient can imagine.
Baseline to Week 13
Brief Pain Inventory
기간: Up to Week 105
The Brief Pain Inventory short form (BPI-SF) includes 4 items assessing pain intensity (pain intensity subscales) and 7 items assessing how much pain has interfered with daily activities (pain interference subscales). The intensity of pain is assessed with 4 items using an 11-point NRS from 0 = no pain to 10 = higher severity of pain. This assessment will be conducted on daily basis.
Up to Week 105
Neuropathic pain symptom inventory (NPSI)
기간: Up to Week 105
The NPSI contains 12 questions designed to evaluate the different symptoms of neuropathic pain. The questions make up the following 5 subscales: burning (superficial) spontaneous pain, pressing (deep) spontaneous pain, paroxysmal pain, evoked pain and paresthesia/dysesthesia. Subscale scores can be derived from averaging the scores from the item scores that make up the subscales, ranging from 0 to 10. A total intensity score is the sum of the subscale scores, ranging from 0 to 100. Higher scores indicate worse pain. This assessment will be conducted on daily basis.
Up to Week 105
Patient Global Impression of Change (PGIC)
기간: Up to week 105
The patient will be asked to rate their change in their neuropathic pain with the following responses: very much improved, much improved, minimally improved, not changed, minimally worse, much worse, or very much worse. This assessment will be conducted on daily basis.
Up to week 105
Number of patients with adverse events
기간: Up to week 105 and 26 weeks after the last dose of study medication
Up to week 105 and 26 weeks after the last dose of study medication

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

2009년 11월 1일

기본 완료 (실제)

2011년 6월 1일

연구 완료 (실제)

2011년 6월 1일

연구 등록 날짜

최초 제출

2009년 10월 8일

QC 기준을 충족하는 최초 제출

2009년 10월 8일

처음 게시됨 (추정)

2009년 10월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 6월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 5월 9일

마지막으로 확인됨

2016년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CR016438
  • 42160443NPP2002 (기타 식별자: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)
  • 2008-007676-13 (EudraCT 번호)

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. .

JNJ-42160443 (1 mg)에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

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CROs in Spain

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다