Randomized Controlled Double Blind Trial of Short vs Long Acting Dihydrocodeine in Chronic Non-malignant Pain

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Controlled Double Blind Trial of Short vs Long Acting Dihydrocodeine in Chronic Non-Malignant Pain

Conditions
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Pain

Intervention / Treatment
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* Drug: Dihydrocodeine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic pain Use 5-10 P.Forte every day for the last two weeks 18-75 years. Exclusion Criteria: Cancer Hepatic failure Severe mental disorders History of known substance abuse.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Active dihydrocodeine, long acting and Placebo dihydrocodeine short acting | Drug: Dihydrocodeine<br>* 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<br>|
| Active Comparator: 2<br>Placebo dihydrocodeine, long acting and active dihydrocodeine short acting. | Drug: Dihydrocodeine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dihydrocodeine, opioids, long acting, opioids, short acting, Chronic pain, non-malignant pain