Condition category
Not Applicable
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
13/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.lumc.nl/

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

Publication citations

Additional files

Editorial Notes