To estimate the onset of analgesia of the oxycodone IR formulation OxyNorm Instant using an acute pain model in healthy volunteers.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain relief in response to a acute painful stimulus
Secondary outcome
none
Background summary
Despite the availability of various treatment strategies, the treatment of
chronic pain remains a tedious and sometimes difficult task. Pharmacological
interventions rely predominantly on the administration of slow-release strong
opioids. While these strong opioids do take care of low intensity background
pain, high intensity breakthrough pain remains a serious problem that is often
difficult to treat. One option is the administration of rapidly acting opioids
when breakthrough pain occurs. However, there is a large variability in the
onset of analgesia between rapid acting opioids (ranging from 5 minutes to 25
min) depending on the physicochemical properties of the drug, the route of
administration and the preparation (oral, sublingual, rectal, etc.). Since
breakthrough pain occurs often suddenly without prior warning, knowledge on the
onset of analgesia is important and consequently the choice of a specific
treatment is most importantly dependent on the onset of analgesia.
Various opioids are available for the treatment of breakthrough pain in a
variety of formulations and administration routes. Most of these opioids have
an onset of analgesia ranging from 10-20 min. A relatively new opioid
formulation is the oxycodone IR oral melt tablet, OxyNorm Instant, registered
for the treatment of severe pain which requires the use of strong opioids.
Although this is a simple and well acceptable method of opioid administration,
also in the severely-ill patient, knowledge on the onset of analgesia is
lacking. In the current study we will assess the onset of analgesia of 20 mg
Oxynorm Instant in healthy volunteers in a randomized controlled cross-over
design. We will compare the OxyNorm Instant effect versus Paracetamol as this
drug is available as a melt tablet as well.
Study objective
To estimate the onset of analgesia of the oxycodone IR formulation OxyNorm
Instant using an acute pain model in healthy volunteers.
Study design
Randomized double-blind crossover
Study burden and risks
The burden is small. Risks or better side effects include
sedation
nausea
respiratory depression
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-002227-15-NL |
| CCMO | NL40882.058.12 |