Chronic pain
Conditions
Interventions
Experimental group:OTR-OXY
control group:OXY-OTR
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Chinese male or female subjects with histories of chronic pain regardless of the aetiology, aged 18-55 years both inclusive; 2. The average pain over the last 24 hours should be scored < 4 assessed with Numeric Rating Scales (NRS), when not receiving analgesics. The pain condition had been kept stable at least in the past 7 days prior to entering into the screening and was expected to be stable during the study duration; 3. Body weight = 45 kg and a body mass index (BMI) = 18 and = 28 kg/m2; 4. Karnofsky score of Performance Status = 70; 5. Willing to take all the food supplied while the subject was in the Study Center; 6. Be able to read, understand, and sign written Informed Consent Form (ICF) prior to study participation and be willing to follow the protocol requirements; 7. Willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control was defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, some Intrauterine Device (IUD), sexual abstinence, or vasectomised partner; 8. Female subjects, including those up to less than one year post-menopausal, must have a negative serum pregnancy test and be non-lactating.
Exclusion criteria
Exclusion criteria: 1. Subjects who were currently taking opioids or have used opioids in the past 14 days prior to receiving the IMP; 2. Had hypersensitivity history to any opioids, naltrexone, naloxone, or related compounds or any contraindications as detailed in the OTR? and OXYCONTIN? tablet Summary of Product Characteristics; 3. Histories of or any current conditions that might interfere with drug absorption, distribution, metabolism, or excretion; 4. Subjects who were likely to have paralytic ileus or acute abdomen or to require an operation on abdominal region; 5. Subjects with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency; 6. Subjects with respiratory depression, corpulmonale, or chronic bronchial asthma; 7. Any history of seizures or symptomatic head trauma; 8. Subjects with abnormal liver function (values exceeding the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin during the Screening Phase) or abnormal renal function (values exceeding the ULN for serum creatinine during the Screening Phase). Note: if the values of ALT, AST or total bilirubin were between 1 to 1.2 times of ULN and confirmed not clinically significant by the Investigators, the subject may be recruited after getting the approval from Sponsor; 9. Any other significant illness other than the primary disease of chronic pain during the 4 weeks preceding the entry into this study; 10. Subjects who were unable to stop taking monoamine oxidase inhibitors during this trial period or time lapses less than 2 weeks since drug withdrawal prior to the IMP administration; 11. Subjects who were currently taking tricyclic antidepressants or had used tricyclic antidepressants within 4 weeks prior to the IMP administration; 12. Subjects who had used any medicinal product which inhibits CYP3A4 (e.g. troleandomycin, ketoconazole, gestodene, etc.) or induces CYP3A4 (e.g. glucocorticoids, barbiturates, rifampicin, etc.) within 4 weeks prior to the IMP administration; 13. Subjects who had used any medicinal product which inhibits CYP2D6 (e.g. fluoxetine, quinidine, ritonavir, etc.) or induces CYP2D6 (e.g. dexamethasone, rifampicin, glutethimide, etc.) within 4 weeks prior to the IMP administration. 14. Histories of smoking (being a smoker or an occasional smoker) within 45 days prior to the IMP administration and refusal to abstain from smoking during the study. According to World Health Organization (WHO), a smoker is defined as having smoked at least 1 cigarette per day continuously for more than 6 months and an occasional smoker is defined as having smoked for more than 4 times per week and less than 1 cigarette per day continuously for more than 6 months; 15. Subjects with histories of alcoholism or drug abuse. Alcoholism is defined as regular alcohol consumption exceeding 14 drinks/week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor). 16. Consumption of alcoholic beverages within 48 hours before IMPadministration, and refusal to abstain from alcohol for at least 48 hours after IMP administration; 17. Refusal to abstain from food for 10 hours preceding and 4 hours following administration of the IMP and to abstain from caffeine or xanthine entirely during each confinement; 18. Positive Hepatitis B Surface Antigen (HBsAg), anti-Hepatitis C Virus (HCV), anti-Human Immunodeficiency Virus (HIV), or syphilis antibody test result; 19. Urine screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma drug concentration; | — |
Countries
China
Contacts
Public ContactLUO ZHU
West China Hospital, Sichuan University
Outcome results
None listed