Chronic Pain
Conditions
Interventions
Test Group:OTR 10 mg
Control Group:OXYCOTIN 10 mg
Sponsors
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
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 etiology, aged 18-55 years both inclusive; 2. The average pain over the last 24 hours was scored =45 kg and a body mass index (BMI) 18 to 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 unit; 6. Was able to read, understand, and sign written Informed Consent Form (ICF) prior to study participation and was 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 resulted in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, some Intrauterine Device (IUD), sexual abstinence, or vasectomised partner; 8. Female subjects, including those up to less than one year post-menopausal, had a negative serum pregnancy test and were non-lactating.
Exclusion criteria
Exclusion criteria: 1. Subjects who were taking opioids during the study or had used opioids in the past 14 days prior to receiving the study drug; 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 abnormal regions; 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 minotransferase [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 study drug administration; 11. Subjects who were currently taking tricyclic antidepressants or had used tricyclic antidepressants within 4 weeks prior to the study drug administration; 12. Subjects who had used any medicinal product which inhibited CYP3A4 (e.g. troleandomycin, ketoconazole, gestodene, etc.) or induced CYP3A4 (e.g. glucocorticoids, barbiturates, rifampicin, etc.) within 4 weeks prior to the study drug administration; 13. Subjects who had used any medicinal product which inhibited CYP2D6 (e.g. fluoxetine, quinidine, ritonavir, etc.) or induced CYP2D6 (e.g. dexamethasone, rifampicin, glutethimide, etc.) within 4 weeks prior to the study drug administration; 14. Histories of smoking (being a smoker or an occasional smoker) within 45 days prior to the study drug administration and refusal to abstain from smoking during the study. According to World Health Organization (WHO), a smoker was defined as having smoked at least 1 cigarette per day continuously for more than 6 months and an occasional smoker was 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 was 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 study drug administration, and refusal to abstain from alcohol for at least 48 hours after study drug administration; 17. Refusal to abstain from food for 10 hours preceding and 4 hours following administration of the study drug 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 Immunodefic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactWenping Wang
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Outcome results
None listed