Randomized Controlled Double Blind Trial of Short vs Long Acting Dihydrocodeine in Chronic Non-malignant Pain
NCT ID: NCT00547885
Last Updated: 2014-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2007-10-31
2012-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Active dihydrocodeine, long acting and Placebo dihydrocodeine short acting
Dihydrocodeine
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
2
Placebo dihydrocodeine, long acting and active dihydrocodeine short acting.
Dihydrocodeine
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
Interventions
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Dihydrocodeine
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
Eligibility Criteria
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Inclusion Criteria
* Use 5-10 P.Forte every day for the last two weeks
* 18-75 years.
Exclusion Criteria
* Hepatic failure
* Severe mental disorders
* History of known substance abuse.
18 Years
75 Years
ALL
No
Sponsors
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Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Petter C Borchgrevink, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Norwegian University of Science and Technology
Locations
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National Competency Centre for Complex Disorders
Trondheim, Sør-Trøndelag, Norway
Countries
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References
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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.
Other Identifiers
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2007-003639-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OPI 07-002
Identifier Type: -
Identifier Source: org_study_id