NL-OMON40164已完成2 期
Efficacy, safety and tolerability of multiple doses of oral cebranopadol in subjects with moderate to severe chronic pain due to diabetic peripheral neuropathy - KF6005/08 study
Grunenthal0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Informed consent signed (Visit 1).
- •2. Male or female subjects aged 18 years to 80 years inclusive at the
- •Enrollment Visit (Visit 1).
- •3. All subjects must have type 1 or type 2 diabetes mellitus and must
- •have a documented clinical diagnosis of painful DPN with
- •symptoms and signs for at least 3 months and pain present at the
- •Enrollment Visit (Visit 1).
- •4. The investigator considers the subject*s blood glucose to be
- •controlled by a diet, oral anti-hyperglycemic medication, and/or insulin for at least 3 months prior to Enrollment Visit. This control should be documented. Hemoglobin (HbA1C) should not be greater than 11% at the Enrollment Visit (Visit 1).
- •5. Subject must require medication (e.g., non-opioids or opioids up to
- •an equivalent dose of 160 mg oral morphine/day) for the treatment of pain due to DPN for at least 1 month prior to Visit 1 and must be dissatisfied with the current treatment (in terms of efficacy and/or tolerability). Medication for the treatment of pain due to DPN should be required on at least 4 of 7 consecutive days.
- •6. Subjects must be using medically acceptable and highly effective methods of birth control (and willing to use them during the trial):
- •For women of childbearing potential: A medically acceptable and highly effective method of birth control is defined as any form of contraception with a low failure rate defined as <1% per year. For example:
- •Hormonal contraceptives for at least 2 months prior to the
- •Enrollment Visit and until at least 4 weeks after Visit 7.
- •An intra-uterine device.
- •Additional barrier contraception must be used by the partner for the duration of the trial. A double-barrier method should be supplemented by the use of spermicidal agents.
- •Women of non-childbearing potential may be included if surgically sterile (i.e., after hysterectomy) or post-menopausal for at least
- •For men: Men have to use barrier contraception (condom) during sexual intercourse for the duration of the trial. The male subject has to take care that the female sexual partner uses at least 1 additional method of contraception with a low failure rate defined as <1% per year (e.g., oral contraceptives) during this time frame.
- •7. Women of childbearing potential must have a negative urine
- •β-human chorionic gonadotropin (β-hCG) pregnancy test at the
- •Enrollment Visit (Visit 1) and at the Baseline Visit (Visit 3).
- •8. A baseline pain intensity score >=5 on the 11-point NRS without
- •intake of any analgesic (including rescue medication) at Visit 3. For each of the last 3 days prior to Visit 3, a 24-hour NRS score >=4 is required.
- •The baseline pain will be calculated as the average over the three
- •24-hour pain assessments of the last 3 days prior to the Baseline
- •Visit (Visit 3).
排除标准
- •Presence of other pain that could confound the assessment of, or
- •contribute to, painful DPN. Such pain could include, but is not
- •limited to, pain due to nerve entrapment (e.g., tarsal tunnel syndrome, osteoarthritis of the knee), peripheral vascular disease, radiculopathy, plantar fasciitis, tendonitis, mononeuritis multiplex, postherpetic neuralgia, complex regional pain syndrome, or fibromyalgia.
- •2. Neuropathy due to etiologies other than diabetes. These
- •neuropathies include, but are not limited to, those associated with
- •autoimmune disorders, inflammatory neuropathies (e.g., chronic inflammatory demyelinating polyneuropathy), thyroid disease or endocrine disorders (other than diabetes), heavy metal or toxic neuropathy, nutritional deficiency, metabolic disorders, vasculitis, infections, injury, or paraneoplastic syndromes.
- •3. Severe or extensive diabetic ulcers or amputations of the limbs (i.e.,
- •more than 2 toes) or Charcot*s joints due to diabetes. Subjects who
- •have had an amputation for a reason other than diabetes (e.g., injury) may be eligible for this trial.
- •4. Any clinically significant disease or laboratory findings that in the investigator*s opinion may affect efficacy or safety assessments or
- •may compromise the subject*s safety during trial participation, e.g., significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, metabolic, neurological, or psychiatric disorders.
- •5. Any medical or other reason (e.g., known or suspected inability of
- •the subject to comply with the protocol and with the use of the
- •IMP) that, in the investigator*s opinion, might indicate that the subject is unsuitable for the trial.
- •6. Conditions that require treatment with forbidden medication (see
- •Section 10.6.2).
- •7. Use of forbidden concomitant medication as specified in
- •Section 10.6.2.
- •8. Previous or current alcohol or drug abuse or opioid dependency,
- •according to the investigator*s judgment, based on the subject*s
- •history, examination, and the result of the drugs of abuse test. Subjects with positive urine drug test explained by a medically indicated treatment are allowed to participate in the trial as long as not specified otherwise in Section 10.6.2.
- •9. Subjects with severe functional hepatic impairment corresponding
- •to Child-Pugh classification C. Subjects with impaired hepatic cellular integrity indicated by AST or ALT greater than 3 x ULN.
- •10. History of acute hepatitis within 3 months of Visit 1 or chronic
- •hepatitis or a positive result on anti-hepatitis A IgM antibody within the past 6 months, hepatitis B surface antigen, or anti-hepatitis C antibody.
- •11. Subjects with impaired renal function with a creatinine clearance
- •less than 60 mL/min at the Enrollment Visit (Visit 1) (calculated from the Cockcroft-Gault [1976] formula).
- •12. History of any major gastrointestinal prior procedures (e.g., gastric bypass) or gastrointestinal conditions (e.g., acute diarrhea, blind
- •loop syndrome, gastric dumping syndrome, Whipple*s disease) that might affect the absorption or metabolism of cebranopadol.
- •13. Presence of risk factors for (e.g., heart failure, hypokalemia, or
- •bradycardia), or history of, torsade de pointes and/or marked prolongation of the corrected QT (Fridericia) (QTcF >450 ms).
- •14. History of seizure disorder and/or epilepsy or any condition
- •associated with a significant risk for seizure disorder
研究者
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