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 |
| Protocol serial number | NTR229 |
| Sponsor | Leiden University Medical Centre (LUMC) (Netherlands) |
| Funder | CeNes Ltd (UK) |
- 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
Scientific
Leiden University Medical Centre (LUMC)
Department of Anesthesiology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| adahan@lumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Post-operative pain |
| Intervention | Drug administration (blinded): morphine or M6G. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Morphine |
| Primary outcome measure(s) |
Pain relief related parameters (Visual Analogue Scale [VAS] to heat pain) in males versus females. |
| Key secondary outcome measure(s) |
PK parameters |
| Completion date | 01/11/2006 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | Healthy volunteers, aged 18+ years |
| Key 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 |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 01/11/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
