NL-OMON54257招募中4 期
Reversal of opioid-induced respiratory depression with opioid antagonists - a study in opioid naïve individuals and chronic opioid users under real-life conditions - Reversal of OIRD
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 24
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
- •Healthy volunteers
- •1. Signed the informed consent form (ICF) and able to comply with the study
- •requirements and restrictions listed therein;
- •2. Male and female subjects, age 18 to 70 years, inclusive;
- •3. Women of childbearing potential (defined as all women who are not surgically
- •sterile or postmenopausal for at least 1 year prior to informed consent) must
- •have a negative serum pregnancy test prior to enrolment and must agree to use a
- •medically acceptable means of contraception from screening through at least 1
- •month after the last dose of study drug;
- •4. Body Mass Index (BMI) 18 to 30 kg/m2, inclusive;
- •5. Healthy as defined by the Investigator, based on a medical evaluation that
- •includes the subject*s medical and surgical history, physical examination,
- •vital signs;
- •6. No history of substance use disorder;
- •7. Normal renal function, normal liver function
- •8. negative serology: HIV, hepatitic B and C
- •Chronic opioid users
- •1. Signed the consent form and able to comply with the requirements and
- •restrictions listed therein;
- •2. Males or females age 18 to 70 years, inclusive;
- •3. Women of childbearing potential (defined as all women who are not surgically
- •sterile or postmenopausal for at least 1 year prior to informed consent) must
- •have a negative serum pregnancy test prior to enrolment and must agree to use a
- •medically acceptable means of contraception from screening through at least 3
- •months after the last dose of study drug.
- •4. BMI 18 to 32 kg/m2, inclusive;
- •5. Opioid tolerant patients administered prescription opioids at daily doses >=
- •60 mg oral morphine equivalents (See Table 3);
- •6. Stable as defined by the Investigator, based on a medical evaluation that
- •includes the subject*s medical and surgical history, physical examination,
- •vital signs, 12-lead ECG, hematology, and blood chemistry;
- •7. positive opioid urine drug screening;
- •8. positive naloxone challenge.
排除标准
- •1. Currently meet the criteria for diagnosis of substance use disorder
- •according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5
- •criteria on any substance;
- •2. Any other active medical condition, organ disease or concurrent medication
- •or treatment that may either compromise subject safety or interfere with study
- •3. Consume, on average, >27 20 units/week of alcohol in men and > 20 13
- •units/week of alcohol in women (1 unit = 1 glass (250 mL) beer, 125 mL glass of
- •wine or 25 mL of 40% spirit);
- •4. Previous or current treatment with opioid agonist, partial agonist, or
- •antagonist treatment within 30 days prior to the first study drug
- •administration;
- •5. Significant traumatic injury, major surgery, or open biopsy within the prior
- •4 weeks of informed consent;
- •6. History of suicidal ideation within 30 days prior to informed consent or
- •history of a suicide attempt in the 6 months prior to informed consent;
- •7. Measured systolic blood pressure greater than 160 or less than 95 mmHg or
- •diastolic pressure greater than 95 mmHg at screening;
- •8. History or presence of allergic response to fentanyl, sufentanil or naloxone
- •or nalmefene;
- •9. Subjects who have demonstrated allergic reactions (e.g., food, drug, atopic
- •reactions or asthmatic episodes) which, in the opinion of the Investigator and
- •sponsor, interfere with their ability to participate in the trial;
- •10. Treatment with another investigational drug within 3 months prior to dosing
- •or having participated in more than 4 investigational drug studies within 1
- •year prior to screening;
- •11. Site staff or subjects affiliated with, or a family member of, site staff
- •directly involved in the study;
- •Chronic opioid users
- •1. Currently meet the criteria for diagnosis of moderate or severe substance
- •use disorder according to the DSM-5 criteria on any substances other than
- •opioids, caffeine, or nicotine;
- •2. Any active medical condition, organ disease or concurrent medication or
- •treatment that may either compromise subject safety or interfere with study
- •3. Consume, on average, >27 units/week of alcohol in men and >20 units/week of
- •alcohol in women (1 unit = 1 glass (250 mL) beer, 125 mL glass of wine or 25 mL
- •of 40% spirit);
- •4. Currently receiving medication-assisted treatment for the treatment of
- •opioid-use disorder;
- •5. Significant traumatic injury, major surgery, or open biopsy within the prior
- •4 weeks of informed consent;
- •6. History of suicidal ideation within 30 days prior to informed consent or
- •history of a suicide attempt in the 6 months prior to informed consent;
- •7. Measured systolic blood pressure greater than 160 or less than 95 mmHg or
- •diastolic pressure greater than 95 mmHg at screening;
- •8. History or presence of allergic response to study medicationfentanyl,
- •sufentanil, nalmefene or naloxone;
- •9. Opioid tolerant patients who have demonstrated allergic reactions (e.g.,
- •food, drug, atopic reactions or asthmatic episodes) which, in the opinion of
- •the Investigator and sponsor, interfere with their ability to participate in
- •10. Estimated glomerular filtration rate <60 mL/min as estimated by the CKD-EPI
- 另有 3 项未显示
研究者
相似试验
进行中（未招募）
1 期
Treatment of respiratory depression from opioids in healthy volunteers and opioid usersEUCTR2021-005373-51-NLeiden University Medical Center24
进行中（未招募）
1 期
Reversal of opioid-induced respiratory depression by ketamine in healthy volunteersRespiratory depressionMedDRA version: 19.0Level: LLTClassification code 10069144Term: Acute respiratory insufficiencySystem Organ Class: 100000004855MedDRA version: 19.0Level: LLTClassification code 10038701Term: Respiratory insufficiencySystem Organ Class: 100000004855EUCTR2016-002148-17-NLMC12
招募中
不适用
Reversal of opioid-induced respiratory depression (OIRD) by ketamine in healthy volunteersNL-OMON24921MC12
已完成
不适用
Reversal of opioid-induced respiratory depression (OIRD) by ketamine in healthy volunteers * the ORKA trialopioid-geinduceerde ademdepressieOpioid-induced respiratory depressionNL-OMON43104eids Universitair Medisch Centrum12
已完成
不适用
PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY)Patients monitored by capnoGraphYJPRN-UMIN000026993Covidien Japan Inc.1,650