Breakthrough pain Signs and Symptoms
Conditions
Interventions
Patients are randomised to two groups: administration of either oxycodone 20 mg or paracetamol 500 mg. Participants are then crossed over and the treatment is swapped. Antinociceptive responses to ele
Sponsors
Leiden University Medical Center (Netherlands)
Eligibility
Sex/Gender
Female
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. 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: 11.1. Respiratory depression 11.2. Head injury 11.3. Paralytic ileus 11.4. Acute abdomen 11.5. Chronic constipation 11.6. Severe obstructive airways disease 11.7. Severe bronchial asthma 11.8. Cor pulmonale 11.9. Hypercarbia 11.10 Acute hepatic disease 11.11.Severe hepatic impairment 11.12. Severe renal impairment (creatinine clearance <10 ml/min) 11.13. Cyanosis 11.14. Concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Efficacy is measured as a difference in pain threshold and pain tolerance scores of the OxyNorm Instant treated subjects as compared to paracetamol treated subjects at different time points 2. To determine the onset of analgesia of OxyNorm Instant. Onset of analgesia is defined as the time point at which the OxyNorm Instant treated patients display significantly increased levels of pain threshold and/or pain tolerance | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
Netherlands
Outcome results
None listed