Non-malignant Chronic PainPhase 3NCT00356083
Opioid Rotation From Morphine to Methadone in Treatment of Non-malignant Pain
A Phase 3 study testing Methadone in people with Non-malignant Chronic Pain, run by Norwegian University of Science and Technology.
Trial summary
Patients with non-malignant pain are switched from morphine to methadone with a nine-months' follow-up. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-malignant Chronic Pain
- What is being tested?
- Methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Mar 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years of age
- non-malignant chronic pain
- morphine use
Who cannot join
- addiction
- kidney disorders
About this study
Official title: 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.
Patients with non-malignant pain are switched from morphine to methadone with a nine-months' follow-up.
Read the detailed description
Twelve patients with poor pain control or unacceptable side effects during treatment with morphine were switched to methadone and followed for nine months in this open prospective study. Primary outcomes were patient preference for opioid and pain control while physical, cognitive and role functioning were secondary outcomes. The morphine dose was decreased by 1/3 daily and was replaced with an equianalgesic dose of methadone over a three-day period. During switching and a one-week dose titration period, patients were given additional methadone if required. During dose titration one patient experienced sedation requiring naloxone. Four patients were switched back to morphine due to poor pain control, drowsiness or sweating. Seven patients preferred long-term (>nine months) treatment with methadone and reported reduced pain and improved functioning while cognition was not improved. This study brings novel information on the long-term consequences for pain control, health-related quality of life and cognitive functioning with a switch from morphine to methadone in the treatment of chronic non-malignant pain.
- Conditions
- Non-malignant Chronic Pain
- Being tested
- Methadone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
| Study group | Role | What they receive |
|---|---|---|
| switch from morphine to methadon | Experimental | Not described Receives: Drug: Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startJan 2004
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-malignant Chronic PainStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petter C. Borchgrevink, PhD MD, Principal investigator, Norwegian University of Science and TechnologyPetter C Borchgrevink, MD PhD, Study chair, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356083
- Sponsor's protocol ID
- 188-03REK
- Status last verified
- Jul 2016
- First submitted
- 24 Jul 2006
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16877186Fredheim 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.
PubMed 16482756
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00356083
- Acronym / sponsor ID
- 188-03REK
- Conditions
- Non-malignant Chronic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 25 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with non-malignant pain are switched from morphine to methadone with a nine-months' follow-up.
Detailed description
Twelve patients with poor pain control or unacceptable side effects during treatment with morphine were switched to methadone and followed for nine months in this open prospective study. Primary outcomes were patient preference for opioid and pain control while physical, cognitive and role functioning were secondary outcomes. The morphine dose was decreased by 1/3 daily and was replaced with an equianalgesic dose of methadone over a three-day period. During switching and a one-week dose titration period, patients were given additional methadone if required. During dose titration one patient experienced sedation requiring naloxone. Four patients were switched back to morphine due to poor pain control, drowsiness or sweating. Seven patients preferred long-term (>nine months) treatment with methadone and reported reduced pain and improved functioning while cognition was not improved. This study brings novel information on the long-term consequences for pain control, health-related quality of life and cognitive functioning with a switch from morphine to methadone in the treatment of chronic non-malignant pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| switch from morphine to methadon | Experimental | Drug: Methadone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-70 years of age
- non-malignant chronic pain
- morphine use
Key exclusion criteria (2 listed)
- addiction
- kidney disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methadone | Drug | switch from morphine to methadon |
Primary outcome
pain
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
- Background: PubMed 16877186Fredheim 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.
- Results publication: PubMed 16482756Fredheim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petter C. Borchgrevink, PhD MD principal investigator
Norwegian University of Science and Technology
Petter C Borchgrevink, MD PhD study chair
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methadone in people with Non-malignant Chronic Pain, run by Norwegian University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00356083, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.