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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Dihydrocodeine

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Sør-Trøndelag
    • Trondheim, Sør-Trøndelag, Norway, 7049
      • National Competency Centre for Complex Disorders

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Active dihydrocodeine, long acting and Placebo dihydrocodeine short acting	Drug: 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
Active Comparator: 2; Placebo dihydrocodeine, long acting and active dihydrocodeine short acting.	Drug: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Investigators: Principal Investigator: Petter C Borchgrevink, PhD, MD, Norwegian University of Science and Technology

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: October 22, 2007
• First Submitted That Met QC Criteria: October 22, 2007
• First Posted (Estimate): October 23, 2007

Study Record Updates

• Last Update Posted (Estimate): December 31, 2014
• Last Update Submitted That Met QC Criteria: December 30, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Chronic pain; dihydrocodeine; opioids, long acting; opioids, short acting; non-malignant pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Dihydrocodeine
• Other Study ID Numbers: OPI 07-002; 2007-003639-22 (EudraCT Number)