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Double Bedtime Dosing During Immediate-release Morphine Administration to Cancer Patients

NCT00201539 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2015-04-08

No results posted yet for this study

Summary

This is a double -blind randomized crossover study to provide evidence for the expert advice based recommendation of the Expert Working Group of the European Association for Palliative Care (EAPC) that patients during treatment with IR morphine are given a double dose at bed-time that replaces the next 4-hourly dose during night. In addition to the primary, blinded clinical part of the study, an experimental part is also included. This part consists of two open study days were morphine IR is given in the same fashion as the clinical study. The aim is to study whether pharmacokinetic data supports the clinical data.

The use of a double-bedtime IR morphine dose is equal to regularly scheduled IR morphine every 4-hour during night in respect to pain relief during night for patients with pain caused by malignant disease

Conditions

Interventions

DRUG

single dose Morphine

DRUG

double dose Morphine

DRUG

placebo

purchased from the manufacturer of morphine tablets (Nycomed Pharma, Oslo, Norway)

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Paal Klepstad, Md,PhD · St.Olavs University Hospital, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2006-11-30
Completion
2008-02-29

Countries

  • Norway

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00201539 on ClinicalTrials.gov