Chronic Pain
Conditions
Interventions
Arm 1:BUP TDS 20mg for 3 days
Arm 2:BUP TDS 40 mg for 3 days
Arm 3:BUP TDS 40 mg for 4 days
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 chronic pain (regardless of the aetiology, cancer pain excluded), aged 18-55years (both inclusive); 2. The average pain over the last 24 hours should attain = 70; 5. Body mass index (BMI) of 19to 28kg/m2 (both inclusive); and a total body weight >= 50kg; 6. Normal dietary habits (e.g. not vegetarian nor vegan) and willing to only take the food supplied duringthe period of hospitalization; 7. Subjectswho are able to read, understand and sign written informed consent prior to study participation and are willing to follow the protocol requirements; 8. Female subjects of child bearing potential (less than 1 year post-menopausal) must have a negative urine pregnancy test prior to first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of birth control throughout the study such as sterilisation, implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner; Male subjects (surgical history of bilateral vasectomy excluded) with a partner of child bearing potential must be willing to use adequate and highly effective methods of birth control throughout the study.
Exclusion criteria
Exclusion criteria: 1. Unstable condition of the primary disease of chronic pain, which, in the opinion of the investigator, would complicate the subjects participation in the study (e.g. require initiation of new medication); 2. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies); 3. History of seizures or at risk (i.e. head trauma, epilepsy in family, anamnesis, unclear loss of consciousness). 4. Any history of frequent nausea or emesis regardless of aetiology; 5. Malignancy or a history of malignancy; 6. History of orthostatic hypotension; 7. Subjectswho have any medical or surgical conditions that might interfere with transdermal absorption, distribution, metabolism, or excretion of drugs; 8. Positive results for HepatitisB surface antigen (HBsAg), HepatitisC virus antibodies(HCV Ab), human immunodeficiency virus antibodies (HIVAb); 9. Urine screening before study is positive for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, benzodiazepines, phencyclidine, methamphetamine, or cannabinoids or alcohol breath test is positive; 10. Subjects who have a current or past (within 5 years) history of substance or alcohol abuse, or subjects who, in the opinion of the investigator or the sub-investigator, have demonstrated addictive or substance abuse behaviors. Alcohol abuse is defined as.regular alcohol consumption exceeding 14 drinks/week (1 drink = 150 mL of wine or 360 mL of beeror 45 mL of hard liquor); 11. Consumption of alcoholic beverages within 48 hours before patch application, and / or refusal to abstain from alcohol throughout the study until at least 48 hours after patch removal; 12. Use of tobacco-or nicotine-containing products in excess of the equivalent of 5cigarettes per day; 13. Use of any medicinal product which inhibits CYP3A4 (e.g.troleandomycin, ketoconazole, gestodene, etc) or induces CYP3A4 (e.g.glucocorticoids, barbiturates, rifampicin,etc) within 4 weeksprior to first patch administration; 14. Subjects who are currently taking tricyclic antidepressants or have used tricyclic antidepressants within 4 weeks prior to the first patch administration; 15. Subjects taking monoamine oxidase (MAO) inhibiters within the past 14 days prior to the first patch administration; 16. Subjects taking any opioid drug within the past 14 days prior to the first patch administration; 17. Use of prescription or nonprescription drugs, vitamins and dietary supplements within 7days prior to the first patch administration. As an exception, acetaminophen could have been used at doses of =140mm Hg (systolic) or>=90mm Hg (diastolic), following at least 5minutes of rest. If BP is >=40mm Hg (systolic) or >=90mm Hg (diastolic), the BP should be repeated two more times and the average of the three BP values should be used to determine the subjects eligibility; 21. 12-lead ECG demonstrating QTc>450msec or a QRS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability; | — |
Countries
China
Contacts
Public ContactWenping Wang
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Outcome results
None listed