EUCTR2007-001140-47-FR进行中（未招募）1 期
A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894 versus Placebo in Subjects with Diabetic Neuropathic Pain
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject must voluntarily sign and date an informed consent form, approved by an
- •Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to
- •the conduct of any study-specific procedures.
- •2. Subject is male or female between 18 and 70 years of age (inclusive) at the
- •Screening Visit.
- •3. The subject must have a score of 3 or greater on the physical assessment portion of
- •the Michigan Neuropathic Screening Instrument at the Screening Visit.
- •4. At the Baseline Visit the subject must meet the following criteria:
- •? An average score of 4 or greater on the 24-hour average pain score (11-Point
- •Likert Scale) collected for approximately 7 days prior to the Baseline Visit,
- •? A compliance rating of no less than 60% on the 24-hour average pain score
- •(11 Point Likert Scale) collected over approximately 7 days prior to the
- •Baseline Visit.
- •5. Subject must have an average of 4 or greater on the BPI average of pain score at
- •the Baseline Visit.
- •6. Subjects must be able to adhere to the study visit schedule and all other protocol
- •requirements, including the completion of daily pain diaries.
- •7. If female, subject is either not of childbearing potential (defined as
- •postmenopausal for at least two (2) years or surgically sterile [bilateral tubal
- •ligation, bilateral oophorectomy or hysterectomy]) or subject is of childbearing
- •potential and practicing at least one (1) of the following methods of birth control:
- •? Total abstinence from sexual intercourse (minimum 1 complete menstrual
- •? A vasectomized partner
- •? Contraceptives (oral, parenteral or transdermal) for 3 consecutive months
- •prior to study drug administration, or use of an intrauterine device
- •? Double-barrier method (condoms, sponge, diaphragm or vaginal ring with
- •spermicidal jellies or creams) for a minimum of 1 complete menstrual cycle.
- •8. If female, subject must have negative results for pregnancy tests performed:
- •? On serum sample obtained at the Screening Visit within 21 days prior to
- •initial study drug administration, and
- •? Prior to dosing on a urine sample.
- •9. The subject must have a diagnosis of diabetes mellitus (Type 1 or Type 2) and a
- •diagnosis of painful distal symmetric diabetic polyneuropathy.
- •10. Subject's distal symmetric diabetic polyneuropathy must be present for a minimum
- •of six (6) months and should have begun in the feet with relative symmetrical
- •11. Subject has an HgbA1c = 9. Subjects who have an HgbA1c > 9 and = 11 may be
- •included in the study upon the Investigator's consultation with the Abbott Medical
- •12. Subject must be willing to washout of all analgesics (except stable doses of
- •NSAIDs for conditions other than DNP) for at least 5 half-lives of the longest
- •acting analgesic or 2 days whichever is longer and be willing to remain off of
- •medication during the 7 days prior to the Baseline Visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject has a history of an allergic reaction or clinically significant sensitivity or intolerance to acetaminophen or a NNR agonist.
- •2. Subject has a medical condition or illness, which is not well controlled that would, in the opinion of the Investigator, preclude study participation or interfere with the
- •assessment of pain and other symptoms of DNP.
- •3. Subject has a symptomatic diagnosis of fibromyalgia that requires treatment.
- •Subjects who have a diagnosis of fibromyalgia, but do not require treatment, may
- •be included in the study upon the Investigator's consultation with the Abbott Medical Monitor.
- •4. Subject is currently receiving analgesics for conditions other than DNP, except for
- •stable doses of NSAIDs for a non-neuropathic pain condition (e.g. Osteoarthritis).
- •5. Subject has a clinically symptomatic neuropathic pain condition other than DNP.
- •6. Subject requires treatment with a NSAID for a non-neuropathic pain condition (e.g., non-selective or COX-2 inhibitors) at a dose that has not been stable for at least 30 days. If the subject is on a stable dose of NSAIDs (> 30 days), inclusion into the study may be permitted upon discussion with the Abbott Medical Monitor.
- •7. Subject has a functioning implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
- •8. Subject has a history of:
- •? Seizures, including those requiring treatment with anticonvulsant. Febrile seizures will be permitted at the discretion of the Investigator.
- •? Major depressive episode within the past two (2) years (as defined by DSMV IV). Treated major depressive disorder within the past two years may be included upon the Investigator's consultation with the Abbott Medical Monitor.
- •? Major psychiatric disorder including bipolar disorder, schizophrenia or borderline personality disorder.
- •? Other psychiatric disorders as determined by the Investigator.
- •9. Subject has a history of myocardial infarction (MI).
- •10. Subject has unstable angina.
- •11. Subject has ventricular arrhythmia requiring anti-arrhythmic therapy.
- •12. Subject has undergone a cardiac revascularization procedure.
- •13. Subject has New York Heart Association (NYHA) functional heart failure classification of Class III or greater.
- •14. Has stable angina and has had their anti-anginal medication changed or altered
- •within the last 3 months.
- •15. Uncontrolled hypertension (HTN) defined as a systolic BP =150 and/or a diastolic
- •blood pressure = 100 at two consecutive visits (Screening and Baseline).
- •16. Subject has a clinically significant abnormal ECG at Screening.
- •17. Subject has any clinically significant infection/injury/illness within thirty (30) days prior to the Screening Visit.
- •18. Subject has a newly diagnosed clinically significant medical condition that requires therapeutic intervention (within thirty (30) days prior to the Screening
- •Visit) or unstable medical condition that significantly impacts health.
- •19. Subject has an active malignancy of any type or has been diagnosed with or treated for cancer within the past 5 years. Subjects with basal cell carcinoma of the skin that has been successfully treated will be allowed to participate.
- •20. Subject has an active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse judged likely, by the Investigator, to recur during the study period.
- •21. Subject has a positive result for drugs of abuse at Screening with the exception of
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