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

Sponsored by:	Norwegian University of Science and Technology
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00547885

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 questionaires to compare the two treatment arms.

Hypothesis: The painrelief 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 IV

MedlinePlus related topics: Depression

Drug Information available for: Dihydrocodeine Dihydrocodeine Bitartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Controlled Double Blind Trial of Short vs Long Acting Dihydrocodeine in Chronic Non-Malignant Pain

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

Primary Outcome Measures:

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. [ Time Frame: nine weeks ]

Estimated Enrollment:	60
Study Start Date:	October 2007

Arms	Assigned Interventions
1: Active Comparator Active dihydrocodeine, long acting and Placebo dihydrocodeine short acting	Drug: Dihydrocodeine Group 1: 2* 60 mg dihydrocodeine long acting + up to four placebo for short act. Group 2: 3* 60 mg dihydrocodeine long acting + up to six placebo for short act. Group 3: 4* 60 mg dihydrocodeine long acting + up to eight placebo for shortact. Group 4: 2 placebo for long acting + up to 430 mg dihydrocodeine short acting. Group 5: 3 placebo for long acting + up to 630 mg dihydrocodeine short acting. Group 6: 3 placebo for long acting + up to 8*30 mg dihydrocodeine short acting.
2: Active Comparator Placebo dihydrocodeine, long acting and active dihydrocodeine short acting.	Drug: Dihydrocodeine Group 1: 2* 60 mg dihydrocodeine long acting + up to four placebo for short act. Group 2: 3* 60 mg dihydrocodeine long acting + up to six placebo for short act. Group 3: 4* 60 mg dihydrocodeine long acting + up to eight placebo for shortact. Group 4: 2 placebo for long acting + up to 430 mg dihydrocodeine short acting. Group 5: 3 placebo for long acting + up to 630 mg dihydrocodeine short acting. Group 6: 3 placebo for long acting + up to 8*30 mg dihydrocodeine short acting.

Arms

Assigned Interventions

1: Active Comparator

Active dihydrocodeine, long acting and Placebo dihydrocodeine short acting

Drug: Dihydrocodeine

Group 1: 2* 60 mg dihydrocodeine long acting + up to four placebo for short act.

Group 2: 3* 60 mg dihydrocodeine long acting + up to six placebo for short act. Group 3: 4* 60 mg dihydrocodeine long acting + up to eight placebo for shortact.

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.

2: Active Comparator

Placebo dihydrocodeine, long acting and active dihydrocodeine short acting.

Drug: Dihydrocodeine

Group 1: 2* 60 mg dihydrocodeine long acting + up to four placebo for short act.

Group 2: 3* 60 mg dihydrocodeine long acting + up to six placebo for short act. Group 3: 4* 60 mg dihydrocodeine long acting + up to eight placebo for shortact.

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

Contacts

Contact: Petter C Borchgrevink, Phd, Professor	73868766 ext 0047	petter.borchgrevink@ntnu.no
Contact: Line Pedersen, Medical student	99306346 ext 0047	linep@stud.ntnu.no

Locations

Norway, Sør-Trøndelag
National Competency Centre for Complex Disorders	Recruiting
Trondheim, Sør-Trøndelag, Norway, 7049
Contact: Petter C Borchgrevink, Phd, MD 73868766 ext 0047 petter.borchgrevink@ntnu.no
Contact: Line Pedersen, Medical student 99306346 ext 0047 linep@stud.ntnu.no
Principal Investigator: Petter C Borchgrevink, Phd, MD

Sponsors and Collaborators

Norwegian University of Science and Technology

Investigators

Principal Investigator:

Petter C Borchgrevink, Phd, MD, Professor

Norwegian University of Science and Technology

More Information

No publications provided

Responsible Party:	Norwegian University of Science and Technology ( Petter Borchgrevink, Professor )
Study ID Numbers:	OPI 07-002, Eudra-CT nr: 2007-003639-22
Study First Received:	October 22, 2007
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00547885 History of Changes
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

Chronic
non-malignant

Study placed in the following topic categories:

Naphazoline
Dihydrocodeine
Guaifenesin
Central Nervous System Depressants
Narcotics
Pain

Phenylpropanolamine
Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid
Codeine

Additional relevant MeSH terms:

Respiratory System Agents
Dihydrocodeine
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Codeine
Pharmacologic Actions

Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 07, 2009