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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:
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00547885
First received: October 22, 2007
Last updated: December 2, 2012
Last verified: December 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Depression
U.S. FDA Resources

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

Primary Outcome Measures:
  • Pain [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 22, 2007
Last Updated: December 2, 2012
Health Authority: Norway: Norwegian Social Science Data Services

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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on June 17, 2013