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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547885
• Other study ID #: OPI 07-002
• Secondary ID: 2007-003639-22
• Status: Completed
• Phase: Phase 4
• First received: October 22, 2007
• Last updated: December 30, 2014
• Start date: October 2007
• Est. completion date: June 2012

Study information

• Verified date: December 2014
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Norway	National Competency Centre for Complex Disorders	Trondheim	Sør-Trøndelag

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Pedersen L, Borchgrevink PC, Breivik HP, Fredheim OM. A randomized, double-blind, double-dummy comparison of short- and long-acting dihydrocodeine in chronic non-malignant pain. Pain. 2014 May;155(5):881-8. doi: 10.1016/j.pain.2013.12.016. Epub 2013 Dec 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No