NCT00356083

Brief Summary

Patients with non-malignant pain are switched from morphine to methadone with a nine-months' follow-up.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_3

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

January 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

1.2 years

First QC Date

July 24, 2006

Last Update Submit

July 28, 2016

Conditions

Non-malignant Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • pain

    9 months

Study Arms (1)

switch from morphine to methadon

EXPERIMENTAL
Drug: Methadone

Interventions

MethadoneDRUG
switch from morphine to methadon

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • non-malignant chronic pain
  • morphine use

You may not qualify if:

  • addiction
  • kidney disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Fredheim OM, Borchgrevink PC, Hegrenaes L, Kaasa S, Dale O, Klepstad P. Opioid switching from morphine to methadone causes a minor but not clinically significant increase in QTc time: A prospective 9-month follow-up study. J Pain Symptom Manage. 2006 Aug;32(2):180-5. doi: 10.1016/j.jpainsymman.2006.02.010.

    PMID: 16877186BACKGROUND

  • Fredheim OM, Kaasa S, Dale O, Klepstad P, Landro NI, Borchgrevink PC. Opioid switching from oral slow release morphine to oral methadone may improve pain control in chronic non-malignant pain: a nine-month follow-up study. Palliat Med. 2006 Jan;20(1):35-41. doi: 10.1191/0269216306pm1099oa.

    PMID: 16482756RESULT

MeSH Terms

Interventions

Methadone

Intervention Hierarchy (Ancestors)

KetonesOrganic Chemicals

Study Officials

  • Petter C. Borchgrevink, PhD MD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Petter C Borchgrevink, MD PhD

    Norwegian University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2006

First Posted

July 25, 2006

Study Start

January 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

July 29, 2016

Record last verified: 2016-07