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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00547885
First Posted: October 23, 2007
Last Update Posted: December 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose

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.


Condition Intervention Phase
Pain Drug: Dihydrocodeine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Double Blind Trial of Short vs Long Acting Dihydrocodeine in Chronic Non-Malignant Pain

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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


Enrollment: 60
Study Start Date: October 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547885


Locations
Norway
National Competency Centre for Complex Disorders
Trondheim, Sør-Trøndelag, Norway, 7049
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Petter C Borchgrevink, PhD, MD Norwegian University of Science and Technology
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00547885     History of Changes
Other Study ID Numbers: OPI 07-002
2007-003639-22 ( EudraCT Number )
First Submitted: October 22, 2007
First Posted: October 23, 2007
Last Update Posted: December 31, 2014
Last Verified: December 2014

Keywords provided by Norwegian University of Science and Technology:
dihydrocodeine
opioids, long acting
opioids, short acting
Chronic pain
non-malignant pain

Additional relevant MeSH terms:
Dihydrocodeine
Codeine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents