Moderate-to-severe non-cancerous chronic pain
Conditions
Interventions
A:In D1 intravenous pump of NH600001 emulsion for 1 min at 0.3mg/kg once
in D8 intravenous push of alfentanil for 20s at 5.0µg/kg once
in D15 intravenous push of alfentanil at 5.0µg/kg for 20s then intravenous pump of NH600001 emulsion for 1 min at 0.3mg/kg once
B:5.0µg/kg once by intravenous push of alfentanil for 20s in D1
5.0µg/kg by intravenous push of alfentanil for 20s in D8 followed by 0.3mg/kg once by intravenous pump of NH600001 emulsion for 1min
0.3mg/kg once by intravenous pump of NH600001 emulsion for 1min in D15
C:In D1, 5.0µg/kg of alfentanil was administered intravenously for 20s followed by 0.3mg/kg of NH600001 emulsion for 1min
in D8, 0.3mg/kg of NH600001 emulsion was administered intravenously for 1min
in D15, 5.0µg/kg of alfentanil was administered intravenously for 20s
Sponsors
Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Male and female patients with moderate to severe non-cancerous chronic pain aged 18-60 years (including borderline values) at the time of screening; 2. Those with a body mass index (BMI) (including borderline values) in the range of 19 to 26 kg/m2; 3. Patients with moderate-to-severe non-cancerous chronic pain (e.g. patients with frozen shoulder, chronic low back pain, myofascial pain syndrome) with a score of >= 4 on the pain scale (Brief Pain Assessment Scale "average level of pain in the past 24 hours": 0-10); 4. Subjects who have fully understood the purpose, content, procedure and possible risks of the trial and who have voluntarily signed an informed consent form to participate; 5. The subject is able to communicate well with the investigator and is willing and able to comply with the lifestyle restrictions set out in the protocol and cooperate in the completion of the trial.
Exclusion criteria
Exclusion criteria: 1. The investigator determines that the subject has a current and past history of disease or dysfunction that would interfere with the clinical trial, including, but not limited to, a history of chronic or severe disease of the central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, hematologic and lymphatic system, or psychiatric disease; 2. Abnormalities in general physical examination, vital signs, routine blood count, blood biochemistry (including but not limited to: glutamate transaminase (ALT), creatinine (Cr), urea nitrogen (BUN) or urea exceeding 1.5 times the upper limit of normal, fasting blood glucose 6.1 mmol/L or blood potassium > 5.3 mmol/L), urinary routine, coagulation function, whole chest orthopantomogram, abdominal ultrasound who have clinically significant findings; cortisol and ACTH global rhythms or assay values judged abnormal by the investigator and clinically significant; 3. Persons with known allergy to etomidate, opioids, propofol, naloxone or other narcotic drugs and their similar drug components, soy, peanuts, eggs or egg products, or who are allergic (allergic to two or more drugs, the environment or food), or who are prone to rashes, urticaria, etc., or who have a history of allergic disease; 4. Those with a history of anaesthetic accidents, a history of severe adverse reactions to anaesthesia or a family history of anaesthetic accidents; 5. Those with previous ventilation difficulties or suspected difficult airway or predicted difficult tracheal intubation (e.g. modified Mallampti score grade III-IV, congenital small mouth and large tongue, mandibular dysplasia, etc.); 6. Those with previous or current airway disease such as bronchial asthma, chronic obstructive pulmonary disease, sleep apnoea syndrome; 7. Those with a history of adrenocortical insufficiency or adrenal tumours or a history of hereditary disorders of haemoglobin biosynthesis or hereditary acute porphyria; 8. Clinically significant ECG abnormalities detected at screening, including but not limited to QTcF >= 450 msec (men) or >= 470 msec (women); 9. Persons with a history of substance abuse, drug dependence, drug abuse, or a positive urine drug screen (morphine, methamphetamine, ketamine, tetrahydrocannabinol acid and methylenedioxymethamphetamine) within 1 year prior to screening; 10. Those with a history of alcohol abuse (i.e. drinking more than 14 standard units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits at 40% alcohol or 150 mL of wine) or a positive alcohol breath test (result >0) within the 6 months prior to screening, or who are unable to abstain from alcohol during the test; 11. Those who have a positive result on a smoke test, or who have been addicted to smoking (>= 5 cigarettes per day) in the 6 months prior to screening, or who are unable to abstain from smoking (including use of nicotine gum or transdermal nicotine patches) during the trial; 12. Those who have ingested caffeine-containing foods or beverages (e.g., coffee, strong tea, chocolate and caffeine-containing carbonated beverages, cola, etc.) within 48 hours prior to the first dose of the test drug; 13. Persons who have ingested any grapefruit-rich beverage or food within 48 hours prior to the first administration of the test drug; 14. Persons with special food requirements, who are unable to comply with a uniform diet or who have difficulty swallowing; or who are normally an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;physical examination;vital signs;laboratory test;12-lead ECG;Cardiac monitoring;Pulse oximetry;Plasma cortisol and adrenocorticotropic hormone (ACTH) concentrations;Modified Alerated Alertness Sedation Score (MOAA/S);EEG Bispectral Index (BIS);11-point numerical rating scale (NRS); | — |
Countries
China
Contacts
Public ContactWen Ouyang, Guoping Yang
Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University
Outcome results
None listed