PainPhase 4NCT00547885
Randomized Controlled Double Blind Trial of Short vs Long Acting Dihydrocodeine in Chronic Non-malignant Pain
A Phase 4 study testing Dihydrocodeine in people with Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
We wish to compare the effect of long acting vs short acting opioids in chronic non-malignant pain. The study opioid is Dihydrocodeine Continus and Dihydrocodeine 30 mg tablets. We measure pain relief, health related quality of life, sleep, breakthrough pain and depression with validated questionnaires to compare the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Dihydrocodeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2007to Jun 2012
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic pain
- Use 5-10 P.Forte every day for the last two weeks
- 18-75 years.
Who cannot join
- Cancer
- Hepatic failure
- Severe mental disorders
- History of known substance abuse.
Trial locations and contacts
1 site in 1 country.
Norway1 site
National Competency Centre for Complex Disorders
Trondheim, Sør-Trøndelag, 7049
About this study
Official title: Randomized Controlled Double Blind Trial of Short vs Long Acting Dihydrocodeine in Chronic Non-Malignant Pain
We wish to compare the effect of long acting vs short acting opioids in chronic non-malignant pain. The study opioid is Dihydrocodeine Continus and Dihydrocodeine 30 mg tablets. We measure pain relief, health related quality of life, sleep, breakthrough pain and depression with validated questionnaires to compare the two treatment arms.
Hypothesis: The pain relief will be better and more stable with long acting opioids. Quality of sleep, breakthrough pain and quality of life will also be improved with long acting dihydrocodeine.
- Conditions
- Pain
- Being tested
- Dihydrocodeine
- Keywords
- dihydrocodeine, opioids, long acting, opioids, short acting, Chronic pain, non-malignant pain
- Medical subject headings
- Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DihydrocodeineDrug
Group 1: 2* 60 mg dihydrocodeine long acting + up to four placebo short action
Group 2: 3* 60 mg dihydrocodeine long acting + up to six placebo short action
Group 3: 4* 60 mg dihydrocodeine long acting + up to eight placebo short action
Group 4: 2 placebo for long acting + up to 4*30 mg dihydrocodeine short acting
Group 5: 3 placebo for long acting + up to 6*30 mg dihydrocodeine short acting
Group 6: 3 placebo for long acting + up to 8*30 mg dihydrocodeine short acting
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Active dihydrocodeine, long acting and Placebo dihydrocodeine short acting Receives: Drug: Dihydrocodeine |
| 2 | Active comparator | Placebo dihydrocodeine, long acting and active dihydrocodeine short acting. Receives: Drug: Dihydrocodeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Validated questionaires which have been properly translated to Norwegian will be used in the assessment of each outcome variable:Pain, Quality and duration of sleep, Quality of life, Depression, Moods and breakthrough pain will be measured.
Measured: 9 weeks
Secondary outcomes (3)
sleep quality and duration
Validated questionaires which have been properly translated to Norwegian will be used in the assessment of each outcome variable:Pain, Quality and duration of sleep, Quality of life, Depression, Moods and breakthrough pain will be measured.
Measured: 9 weeks
quality of life
Validated questionaires which have been properly translated to Norwegian will be used in the assessment of each outcome variable:Pain, Quality and duration of sleep, Quality of life, Depression, Moods and breakthrough pain will be measured.
Measured: 9 weeks
Depression and moods
Validated questionaires which have been properly translated to Norwegian will be used in the assessment of each outcome variable:Pain, Quality and duration of sleep, Quality of life, Depression, Moods and breakthrough pain will be measured
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 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 Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547885
- Sponsor's protocol ID
- OPI 07-002
- Other IDs
- 2007-003639-22
- Status last verified
- Dec 2014
- First submitted
- 22 Oct 2007
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pedersen L, Borchgrevink PC, Breivik HP, Fredheim OMS. A randomized, double-blind, double-dummy comparison of short- and long-acting dihydrocodeine in chronic non-malignant pain. Pain. 2014 May;155(5):881-888. doi: 10.1016/j.pain.2013.12.016. Epub 2013 Dec 15.
PubMed 24345428
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Double Blind Trial of Short vs Long Acting Dihydrocodeine in Chronic Non-Malignant Pain
- ClinicalTrials.gov ID
- NCT00547885
- Acronym / sponsor ID
- OPI 07-002
- Conditions
- Pain
- Keywords
- dihydrocodeine, opioids, long acting, opioids, short acting, Chronic pain, non-malignant pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Oct 2007 (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.
We wish to compare the effect of long acting vs short acting opioids in chronic non-malignant pain. The study opioid is Dihydrocodeine Continus and Dihydrocodeine 30 mg tablets. We measure pain relief, health related quality of life, sleep, breakthrough pain and depression with validated questionnaires to compare the two treatment arms.
Hypothesis: The pain relief will be better and more stable with long acting opioids. Quality of sleep, breakthrough pain and quality of life will also be improved with long acting dihydrocodeine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: DihydrocodeineActive dihydrocodeine, long acting and Placebo dihydrocodeine short acting |
| 2 | Active comparator | Drug: DihydrocodeinePlacebo dihydrocodeine, long acting and active dihydrocodeine short acting. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic pain
- Use 5-10 P.Forte every day for the last two weeks
- 18-75 years.
Key exclusion criteria (4 listed)
- Cancer
- Hepatic failure
- Severe mental disorders
- History of known substance abuse.
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 |
|---|---|---|
| DihydrocodeineGroup 1: 2* 60 mg dihydrocodeine long acting + up to four placebo short action Group 2: 3* 60 mg dihydrocodeine long acting + up to six placebo short action Group 3: 4* 60 mg dihydrocodeine long acting + up to eight placebo short action Group 4: 2 placebo for long acting + up to 4*30 mg dihydrocodeine short acting Group 5: 3 placebo for long acting + up to 6*30 mg dihydrocodeine short acting Group 6: 3 placebo for long acting + up to 8*30 mg dihydrocodeine short acting | Drug | 1, 2 |
Primary outcome
Pain
Time frame: 9 weeks
Validated questionaires which have been properly translated to Norwegian will be used in the assessment of each outcome variable:Pain, Quality and duration of sleep, Quality of life, Depression, Moods and breakthrough pain will be measured.
3 secondary outcomes
sleep quality and duration
Time frame: 9 weeks
quality of life
Time frame: 9 weeks
Depression and moods
Time frame: 9 weeks
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 31 Dec 2014.
- Results publication: PubMed 24345428Pedersen L, Borchgrevink PC, Breivik HP, Fredheim OMS. A randomized, double-blind, double-dummy comparison of short- and long-acting dihydrocodeine in chronic non-malignant pain. Pain. 2014 May;155(5):881-888. doi: 10.1016/j.pain.2013.12.016. Epub 2013 Dec 15.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dihydrocodeine in people with Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 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 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 weeks). 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 NCT00547885, which also lists 1 linked publication.
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 31 Dec 2014.