Plain English Summary
Background and study aims
Acute and breakthrough pain (sudden additional acute pain on top of the long-term pain) is difficult to treat, especially since the pain requires immediate relief. Various drugs are available with different timings of pain relief. Here we compare the effect of a new painkiller drug in the form of a melt tablet, OxyNorm instant (oxycodone formulation), with an active placebo (dummy) tablet, a paracetamol melt tablet, to assess the speed of pain relief.
Who can participate?
The study will be performed in twelve healthy female volunteers, aged 18 to 65.
What does the study involve?
Pain will be induced experimentally through electrical and pressure pain stimulus. Participants will be randomly allocated to one of two groups. For pain relief, OxyNorm instant will be given to one group and paracetamol to the other. Pain will be recorded over 5 hours following drug intake. Participants are then crossed over (i.e., the treatment is swapped). A mathematical model will be used to analyse the data and get an indication of onset of pain relief.
What are the possible benefits and risks of participating?
There will be no benefit for the participants. However, it will be useful for treating patients appropriately in future. As the drug doses are low, the risks of the study are minimal and include vomiting and itch.
Where is the study run from?
The study is run from the Leiden University Medical Center, Netherlands.
When is the study starting and how long is it expected to run for?
The study started in January 2013 and will run until February 2014.
Who is funding the study?
Mundipharma Pharmaceuticals BV, Netherlands.
Who is the main contact?
Prof. Albert Dahan
a.dahan@lumc.nl
Trial website
Additional identifiers
EudraCT number
2012-002227-15
ClinicalTrials.gov number
Protocol/serial number
POXY/12-124
Study information
Scientific title
A randomized cross-over study on the onset of analgesia with OxyNorm Instant in healthy volunteers
Acronym
Oxy Study
Study hypothesis
Oxycodone produces greater analgesia than the active comparator and meaningful analgesia, as defined by a 15% increase in response thresholds, within 10 min.
Ethics approval
Medical Ethics Committee (Commissie Mediche Ethiek), Leiden University Medical Center, Leiden, The Netherlands, 01/08/2012, Ref: P12.124
Study design
Randomized placebo-controlled double-blind crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet
Condition
Breakthrough pain
Intervention
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 electrical and pressure pain are measured.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 outcome measures
Not provided at time of registration
Overall trial start date
01/01/2013
Overall trial end date
01/02/2014
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
12
Participant 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
Recruitment start date
01/01/2013
Recruitment end date
01/02/2014
Locations
Countries of recruitment
Netherlands
Trial participating centre
Albinusdreef 2
Leiden
2333 ZA
Netherlands
Sponsor information
Organisation
Leiden University Medical Center (Netherlands)
Sponsor details
Albinusdreef 2
Leiden
2333 ZA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Partly by Mundipharma Pharmaceuticals BV (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary