Influence of intravenous versus oral administration, arterial versus venous sampling and gender on pharmacokinetic-pharmacodynamic modelling of morphine and morphine-6-glucuronide-induced pain relief in healthy volunteers

ISRCTN ISRCTN80473151
DOI https://doi.org/10.1186/ISRCTN80473151
Secondary identifying numbers NTR229
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
13/05/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Albert Dahan
Scientific

Leiden University Medical Centre (LUMC)
Department of Anesthesiology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Email adahan@lumc.nl

Study information

Study designRandomised double blind active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThis 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(s)Received from the local medical ethics committee
Health condition(s) or problem(s) studiedPost-operative pain
InterventionDrug administration (blinded): morphine or M6G.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Morphine
Primary outcome measurePain relief related parameters (Visual Analogue Scale [VAS] to heat pain) in males versus females.
Secondary outcome measuresPK parameters
Overall study start date01/11/2005
Completion date01/11/2006

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60
Key inclusion criteriaHealthy volunteers, aged 18+ years
Key exclusion criteria1. 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
Date of first enrolment01/11/2005
Date of final enrolment01/11/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Leiden University Medical Centre (LUMC) (Netherlands)
University/education

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Website http://www.lumc.nl/
ROR logo "ROR" https://ror.org/027bh9e22

Funders

Funder type

Industry

CeNes Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan