Contact information
Type
Scientific
Primary contact
Prof Albert Dahan
ORCID ID
Contact details
Leiden University Medical Centre (LUMC)
Department of Anesthesiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
adahan@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR229
Study information
Scientific title
Acronym
Study hypothesis
This study is designed to get a full pharmacokinetic-pharmacodynamic (PK/PD) characteristic of the opioid analgesic morphine and its active metabolite M6G after oral and intravenous (iv) infusion and to test whether sex differences exist in the analgesic behaviour of both opioids.
Ethics approval
Received from the local medical ethics committee
Study design
Randomised double blind active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Post-operative pain
Intervention
Drug administration (blinded): morphine or M6G.
Intervention type
Drug
Phase
Not Applicable
Drug names
Morphine
Primary outcome measures
Pain relief related parameters (Visual Analogue Scale [VAS] to heat pain) in males versus females.
Secondary outcome measures
PK parameters
Overall trial start date
01/11/2005
Overall trial end date
01/11/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy volunteers, aged 18+ years
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Body mass index (BMI) greater than 30 kg/m^2
2. Pregnancy or lactation
3. Presence of medical disease
4. Presence of psychiatric disease
5. Allergy to study medication
6. History of drugs or alcohol abuse
Recruitment start date
01/11/2005
Recruitment end date
01/11/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Centre (LUMC) (Netherlands)
Sponsor details
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
CeNes Ltd (UK)
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