pijn nociception pain
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Females 2. Age of 18 to 65 years (inclusive); 3. Body Mass Index (BMI) between 18 and 35 kg/m2 (inclusive) and body weight between 50 kg and 100 kg (inclusive); 4. Subject is able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff; 5. Subject is willing to comply with study restrictions
Exclusion criteria
Exclusion criteria: 1. Clinically relevant abnormal history of physical and mental health, as determined by medical history taking and physical examinations obtained during the screening visit and/or prior to the administration of the initial dose of the study drug (as judged by the investigator); 2. A semi recumbent systolic blood pressure of >150 mmHg and/or diastolic blood pressure of > 90 mmHg at screening; 3. History of alcoholism or substance abuse within three years prior to screening; 4. Positive pregnancy test; 5. Subjects using more than 14 units of alcohol per week; 6. Use of medication during the study period; 8. Female subject is not using oral contraceptives, or is not post-menopausal (last menstrual period > 2 years ago and FSH > 25 IU/L) or surgically sterilized; 9. Subject has a history of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food; 10. Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year; 11. Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject: OxyNorm is contra-indicated in case of hypersensitivity for oxycodone or one of its excipients or in any situation where opioids are contra indicated. This can include the following situations: • Respiratory depression • head injury • paralytic ileus • acute abdomen • chronic constipation • severe obstructive airways disease • severe bronchial asthma • cor pulmonale • hypercarbia • acute hepatic disease • severe hepatic impairment • severe renal impairment (creatinine clearance <10ml/min) • cyanosis • concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain relief in response to a acute painful stimulus | — |
Secondary
| Measure | Time frame |
|---|---|
| none | — |
Countries
Netherlands
Outcome results
None listed