A Study in Participants With Diabetic Peripheral Neuropathic Pain in China
2014년 10월 3일 업데이트: Eli Lilly and Company
Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China: Duloxetine Versus Placebo
The purpose of this trial is to assess the efficacy of duloxetine 60 milligrams (mg) once daily (QD) compared with placebo, on the change in pain severity from baseline to 12 weeks as measured by the weekly mean of the daily pain scores recorded in the participant's diary in participants with diabetic peripheral neuropathic pain.
연구 개요
연구 유형
중재적
등록 (실제)
405
단계
- 3단계
연락처 및 위치
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연구 장소
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Beijing, 중국, 100730
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bengbu, 중국, 233004
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Changchun, 중국, 130021
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Chengdu, 중국, 610072
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Chongqing, 중국
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Guang Zhou, 중국, 510515
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Jinan, 중국, 250001
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Nanjin, 중국, 210006
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Qingdao, 중국, 266003
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Shanghai, 중국, 200040
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Shantou, 중국, 515041
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Shi Jia Zhuang, 중국, 050051
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tianjin, 중국, 300211
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Xi'An, 중국, 710061
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Yueyang, 중국, 414000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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:
Present with pain due to bilateral peripheral neuropathy
- Participants must have pain caused by Type 1 or Type 2 diabetes mellitus
- Pain must begin in the feet with relatively symmetrical onset
- Daily pain should be present for at least 6 months
- Diagnosis must be confirmed by a score of at least 3 on the Michigan Neuropathy Screening Inventory (MNSI)
- Females must test negative for a serum pregnancy test at Screening. Females of child-bearing potential (who are not surgically sterilized and between menarche and 1 year postmenopause) must agree to use a medically acceptable and reliable means of birth control, during the study and for 1 month following the last study dose.
- Stable glycemic control as assessed by a physician investigator and a glycosylated hemoglobin (HbA1c) <12% before randomization
- Score of greater than or equal to 4 on the Brief Pain Inventory (BPI) 24-hour average pain item at Screening.
- Full completion of the daily diaries for at least 80% of the days between the second and third time you come to the hospital (Screening).
Exclusion Criteria:
- Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Current (less than or equal to 1 year) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I diagnosis of major depressive disorder, dysthymia, anxiety disorders (excluding phobias), alcohol or eating disorders as determined by the Mini-International Neuropsychiatric Interview (MINI) or a previous diagnosis
- DSM-IV diagnosis of mania, bipolar disorder, or psychosis determined either by participant history or by diagnosis using specific MNSI modules
- Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition or psychological conditions that in the opinion of investigator would compromise participation or be likely to lead to hospitalization during the course of the study.
- At Screening alanine transaminase (ALT) greater than 2 times upper limit of normal (ULN), based on central laboratory reference ranges times ULN, based on central laboratory reference ranges
- Prior renal transplant, current renal dialysis, or serum creatinine laboratory value >1.5 times ULN, based on central laboratory reference ranges at Screening.
- Historical exposure to drugs known to cause neuropathy, or a history of a medical condition, including pernicious anemia and hypothyroidism, that could have been responsible for neuropathy
- Pain that cannot be clearly differentiated from or conditions that interfere with the assessment of the diabetic neuropathy pain. Examples of painful conditions that could be confused with diabetic neuropathy pain include peripheral vascular disease, neurological disorders unrelated to diabetic neuropathy, skin condition in the area of the neuropathy that could alter sensation, other painful conditions
- Participants who have previously completed or withdrawn from this study or have been previously treated with duloxetine, including participants who participated in study F1J-MC-HMEQ (NCT00408993), even those in the placebo arm
- Participants taking excluded medications that cannot be stopped at Screening
- Treatment with a monoamine oxidase inhibitor (MAOI) or fluoxetine within 30 days of the third Screening
Participants with a positive Hepatitis B surface antigen and/or Hepatitis C antibody are to be excluded if they have any of the following:
- Hepatic dysfunction as determined by the investigator or
- Clinical manifestations of liver disease within the previous year such as unexplained pruritus, unexplained dark urine, jaundice, unexplained right upper quadrant tenderness, unexplained "flu-like" symptoms or
- Aspartate transaminase (AST), ALT, or bilirubin above the normal reference range.
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 |
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위약 비교기: 위약
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Administered po, QD for 12 weeks; administered po, QD for 1 week during taper period
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실험적: 둘록세틴
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30 mg administered orally (po), QD for 1 week; 60 mg administered po, QD for remaining 11 weeks; 30 mg administered po, QD for 1 week during taper period
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean Change From Baseline at 12-Week Endpoint in the Weekly Mean of Pain Severity Score
기간: Baseline, 12 weeks
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24-hour average pain severity scores were recorded daily by the participant on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain).
The weekly mean was calculated.
A negative change indicated an improvement in participant's condition.
Least squares (LS) mean was calculated using mixed model repeating measures (MMRM) and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
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Baseline, 12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Change From Baseline at 12-Week Endpoint in Weekly Mean of Night Pain and Worst Pain
기간: Baseline, 12 weeks
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24-hour average night pain and worst pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale, with scores ranging from 0 (no pain) to 10 (worst possible pain).
A negative change indicated an improvement in the participant's condition.
LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as the baseline score and baseline score-by-visit interaction.
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Baseline, 12 weeks
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Mean Change From Baseline at 12-Week Endpoint in the BPI-Severity Scale
기간: Baseline, 12 weeks
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BPI-Severity Scale was a self-reported scale that measured the severity of pain based on the average pain over the past 24-hours.
The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
A negative change indicated an improvement in the participant's condition.
LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
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Baseline, 12 weeks
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Mean Change From Baseline at 12-Week Endpoint in the CGI-S Scale
기간: Baseline, 12 weeks
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CGI-S was administered by the investigator in the presence of the participant and measured the severity of illness at the time of assessment compared with start of treatment; CGI-S scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
A negative change indicated an improvement in the participant's condition.
LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
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Baseline, 12 weeks
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Patient Global Impression of Improvement (PGI-I) Scale at 12-Week Endpoint
기간: 12 weeks
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PGI-I was self-reported and measured a participant's perception of improvement at the time of assessment compared with the start of treatment.
Scores ranged from 1 (very much better) to 7 (very much worse).
LS mean was calculated using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, as well as baseline score and baseline score-by-visit interaction.
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12 weeks
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Mean Change From Baseline at 12-Week Endpoint in the Sensory Subscale of the SF-MPQ
기간: Baseline, 12 weeks
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SF-MPQ was a self-reported instrument that consisted of 11 sensory descriptors describing pain.
The descriptors were rated on an intensity scale from 0 (none), 1 (mild), 2 (moderate) or 3 (severe).
Three (3) pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors.
The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst pain).
A negative change indicates an improvement.
LS mean was calculated using analysis of covariance (ANCOVA) adjusted for treatment, pooled investigator and baseline.
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Baseline, 12 weeks
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Percentage of Participants Who Experience Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-Week Endpoint in Weekly Mean of Average Daily Pain
기간: Baseline, 12 weeks
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24-hour self-assessment of average daily pain was recorded in the participants diary based on an 11 point Likert scale with scores ranging from 0 (no pain) to 10 (worst possible pain).
Percentage of participants was calculated as: (number of participants with 30% [or 50% or 75%] reduction in average daily pain) divided by (number of participants) multiplied by 100.
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Baseline, 12 weeks
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Percentage of Participants Who Experienced Equal to or Greater Than 30%, 50% or 75% Reduction From Baseline at 12-week Endpoint in BPI-Severity Average Pain Score
기간: Baseline, 12 weeks
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BPI-Severity scale was a self-reported scale that measured the severity of pain based on the average pain experienced over the past 24 hours.
The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
A negative change indicated an improvement in the participant's condition.
Percentage of participants was calculated as: (number of participants with 30% [or 50% or 75%] reduction in BPI-Severity average pain) divided by (number of participants) multiplied by 100.
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Baseline, 12 weeks
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Mean Change From Baseline at 12-week Endpoint in the BPI Interference Score
기간: Baseline, 12 weeks
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BPI-Interference Score was a self-reported scale that measured the interference of pain based on the average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
The average interference scores ranged from 0 (does not interfere) to 10 (completely interferes).
A negative change indicates an improvement in the participant's condition.
LS means was calculated using MMRM and adjusted treatment, pooled investigator, visit, and treatment-by-visit interaction, baseline score and baseline score-by-visit interaction.
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Baseline, 12 weeks
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Mean Change From Baseline at 12 Week Endpoint in the SDS Total Score
기간: Baseline, 12 weeks
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SDS was self-reported and used to assess the effect of the participant's symptoms on their work (Item 1), social life (Item 2), and family life (Item 3).
Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption.
SDS total score was the sum of the 3 items and ranged from 0 to 30, with higher values indicating greater disruption in the participant's work/social/family life.
Scores ≥5 were associated with significant functional impairment.
A negative change indicated an improvement in the participant's condition.
LS mean was adjusted using MMRM and adjusted for treatment, pooled investigator, visit, and treatment-by-visit interaction, baseline score and baseline score-by-visit interaction.
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Baseline, 12 weeks
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
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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
2011년 4월 1일
기본 완료 (실제)
2013년 8월 1일
연구 완료 (실제)
2013년 8월 1일
연구 등록 날짜
최초 제출
2010년 8월 10일
QC 기준을 충족하는 최초 제출
2010년 8월 10일
처음 게시됨 (추정)
2010년 8월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 10월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 10월 3일
마지막으로 확인됨
2014년 10월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 13649
- F1J-MC-HMGV (기타 식별자: Eli Lilly and Company)
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. .