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

NCT00547885 | Completed Phase 4 DMC

• 2 other identifiers: OPI 07-0022007-003639-22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Pain

Keywords

dihydrocodeine; opioids, long acting; opioids, short acting; Chronic pain; non-malignant pain

Outcome Measures

Primary Outcomes (1)

• Pain

  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.

  9 weeks

Secondary Outcomes (3)

• sleep quality and duration

  9 weeks

• quality of life

  9 weeks

• Depression and moods

  9 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Active dihydrocodeine, long acting and Placebo dihydrocodeine short acting

Drug: Dihydrocodeine

2

ACTIVE COMPARATOR

Placebo dihydrocodeine, long acting and active dihydrocodeine short acting.

Drug: Dihydrocodeine

Interventions

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

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic pain
• Use 5-10 P.Forte every day for the last two weeks
• years.

You may not qualify if:

• Cancer
• Hepatic failure
• Severe mental disorders
• History of known substance abuse.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

National Competency Centre for Complex Disorders

Trondheim, Sør-Trøndelag, 7049, Norway

Location

Related Publications (1)

• Pedersen L, Borchgrevink PC, Breivik HP, Fredheim OMS. A randomized, double-blind, double-dummy comparison of short- and long-acting dihydrocodeine in chronic non-malignant pain. Pain. 2014 May;155(5):881-888. doi: 10.1016/j.pain.2013.12.016. Epub 2013 Dec 15.

  PMID: 24345428 RESULT

MeSH Terms

Conditions

Pain; Chronic Pain

Interventions

dihydrocodeine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Petter C Borchgrevink, PhD, MD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2007
• First Posted: October 23, 2007
• Study Start: October 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 31, 2014

Record last verified: 2014-12

Locations

NO (1)