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Completed

NCT Number: NCT00547885

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.

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Key information

Conditions

Pain Chronic Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Competency Centre for Complex Disorders

Trondheim, Sør-Trøndelag, 7049, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dihydrocodeine

Drug

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

Primary outcomes

  1. Pain

    Time frame: 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 outcomes

  1. sleep quality and duration

    Time frame: 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.

  2. quality of life

    Time frame: 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.

  3. Depression and moods

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Oct 23, 2007
Registry last updated
Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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