Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-003639-22 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Active dihydrocodeine, long acting and Placebo dihydrocodeine short acting |
|
| 2 | Active Comparator | Placebo dihydrocodeine, long acting and active dihydrocodeine short acting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dihydrocodeine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 weeks |
| quality of life |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Petter C Borchgrevink, PhD, MD | Norwegian University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Competency Centre for Complex Disorders | Trondheim | Sør-Trøndelag | 7049 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24345428 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C014481 | dihydrocodeine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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. |
| 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 | 9 weeks |