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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Dihydrocodeine

• Registration Number: NCT00547885
• Lead Sponsor: Norwegian University of Science and Technology

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-23
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-30
• Last Update Posted: 2014-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Dihydrocodeine	Active dihydrocodeine, long acting and Placebo dihydrocodeine short acting
2	Dihydrocodeine	Placebo dihydrocodeine, long acting and active dihydrocodeine short acting.

Primary Outcome Measures

Name	Time	Method
Pain	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.

Secondary Outcome Measures

Name	Time	Method
quality of life	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.
sleep quality and duration	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.
Depression and moods	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

Trial Locations

Locations (1)

National Competency Centre for Complex Disorders; 🇳🇴 Trondheim, Sør-Trøndelag, Norway