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

NCT00547885 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-12-31

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Petter C Borchgrevink, PhD, MD · Norwegian University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00547885 on ClinicalTrials.gov