NCT00647127

Brief Summary

To compare the analgesic and anti-hyperalgesic effect of Buprenorphine and Fentanyl against experimental pain in skin, muscle and bone. The study will be performed with healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_3 pain

Timeline
Completed

Started Feb 2008

Typical duration for phase_3 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

September 14, 2012

Status Verified

September 1, 2012

Enrollment Period

1.5 years

First QC Date

March 26, 2008

Last Update Submit

September 13, 2012

Conditions

Pain

Keywords

BuprenorphineFentanylAnalgesic effectAnti-hyperalgesic effectExperimental pain

Outcome Measures

Primary Outcomes (1)

  • Data will be electronically recorded or written directly in case report form. Outcome measure will be a subjective rating of the pain with a visual analogue scale.

    Continuously

Study Arms (3)

Buprenorphine

ACTIVE COMPARATOR
Drug: Buprenorphine

Fentanyl

ACTIVE COMPARATOR
Drug: Fentanyl

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BuprenorphineDRUG

Buprenorphine: 20microg/h

Also known as: Norspan
Buprenorphine
FentanylDRUG

Fentanyl: 25microg/h

Also known as: Durogesic
Fentanyl
PlaceboDRUG

Placebo: '5microg/h' (not active drug, it is just called '5microg/h')

Also known as: Norspan
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • written informed consent
  • men \> 18 years

You may not qualify if:

  • women
  • known allergy against the investigated drugs
  • ongoing participation in other experiments or participation in other experiments 14 days before screening
  • previously pain or psychiatric conditions
  • simultaneously use of pain killers
  • alcohol
  • previously drug-addict or member of family with drug-addicts
  • chronic constipation
  • ileus
  • inflammatory bowel syndrome
  • abdominal surgery within the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mech Sense, Department of Gastroenterology

Aalborg, Region Nordjyllan, 9000, Denmark

Location

MeSH Terms

Conditions

Pain

Interventions

BuprenorphineFentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Asbjoern M Drewes, MD, Prof.

    Mech Sense, Department of Gastroenterology, Aalborg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 31, 2008

Study Start

February 1, 2008

Primary Completion

August 1, 2009

Study Completion

January 1, 2010

Last Updated

September 14, 2012

Record last verified: 2012-09

Locations

DK(1)