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

Norwegian University of Science and Technology

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Dihydrocodeine

Study type: Interventional

Funder types: Other

Identifiers

NCT00547885

2007-003639-22 (EudraCT Number)

OPI 07-002

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

1

Active Comparator group

Description:

Active dihydrocodeine, long acting and Placebo dihydrocodeine short acting

Treatment:

Drug: Dihydrocodeine

2

Active Comparator group

Description:

Placebo dihydrocodeine, long acting and active dihydrocodeine short acting.

Treatment:

Drug: Dihydrocodeine