NCT00201539

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_3 cancer

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_3 cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

4.6 years

First QC Date

September 16, 2005

Last Update Submit

April 7, 2015

Conditions

Cancer

Keywords

analgesics, opioid/pharmacokineticshumansmorphine/therapeutic use*neoplasmspain/drugtherapy

Outcome Measures

Primary Outcomes (2)

  • Primary efficacy variable

  • Patient rating of average pain intensity during night measured on a 11-point nu-meric rate scale

Secondary Outcomes (10)

  • Secondary efficacy variables

  • Pain rating of "pain now" before scheduled morning dose measured on a 11-point numeric rate scale

  • Number of rescue opioid medications during night

  • Patient overall rating of sleep quality during night measured on a 11-point nu-meric rate scale

  • Number of episodes being awake during night

  • +5 more secondary outcomes

Study Arms (2)

double dose once

ACTIVE COMPARATOR

double dose immediate-release oral morphine at bedtime in cancer patients, placebo after 4 hours

Drug: double dose MorphineDrug: placebo

single dose twice

EXPERIMENTAL

single dose immediate-release oral morphine at bedtime in cancer patients, second single dose after 4 hrs

Drug: single dose Morphine

Interventions

single dose MorphineDRUG
single dose twice
double dose MorphineDRUG
double dose once
placeboDRUG

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

double dose once

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with malignant disease
  • Age more than 18 year
  • Regular use of oral morphine or pain that indicates start of opioids for moderate or severe pain according to the WHO guidelines for treatment of cancer pain

You may not qualify if:

  • Known morphine intolerance
  • History of drug abuse
  • Decreased gastrointestinal uptake of oral medications
  • Pregnancy or breast-feeding
  • General health condition, psychiatric disease or cognitive function failure giving that the patient is not competent to complete questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Norwegian Univeristy of tecknology and science

Trondheim, Trondheim, 7006, Norway

Location

St Olavs University Hospital

Trondheim, 7006, Norway

Location

Related Publications (1)

  • Dale O, Piribauer M, Kaasa S, Moksnes K, Knobel H, Klepstad P. A double-blind, randomized, crossover comparison between single-dose and double-dose immediate-release oral morphine at bedtime in cancer patients. J Pain Symptom Manage. 2009 Jan;37(1):68-76. doi: 10.1016/j.jpainsymman.2007.12.016. Epub 2008 May 27.

    PMID: 18504090RESULT

MeSH Terms

Conditions

Neoplasms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Paal Klepstad, Md,PhD

    St.Olavs University Hospital, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 20, 2005

Study Start

April 1, 2002

Primary Completion

November 1, 2006

Study Completion

February 1, 2008

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

NO(2)