NCT00886002

Brief Summary

The primary objective of this pilot trial is to identify pain model(s) which allow(s) to compare and differentiate the analgesic effects between transdermal fentanyl 25µg/h, transdermal fentanyl 12µg/h and placebo in a dose dependent way. The second objective is to compare the effects of transdermal buprenorphine 35µg/h in these models with the effect of the two transdermal fentanyl dosages. Therefore four different treatments are given; all treatments will be by means of a patch that is attached to the back for 72 hours.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_1 pain

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_1 pain

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

November 1, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

First QC Date

April 20, 2009

Last Update Submit

June 18, 2010

Conditions

Pain

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • The first objective of the trial is to identify which acute pain model differentiates best between placebo and transdermal fentanyl 25µg/h.

Secondary Outcomes (1)

  • The second objective is to investigate, whether a significant dosage effect correlation exists in the target model between transdermal fentanyl 25µg/h, 12µg/h and placebo and TRANSTEC 35 mcg/h.

Interventions

Fentanyl; Buprenorphine; NaloxoneDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy on the basis of a pre-study physical examination
  • Subjects who are willing to be hospitalized
  • subjects who are willing and able to participate in the pain tests and show responsive pain pattern

You may not qualify if:

  • History or presence of liver or renal insufficiency
  • acute liver inflammation, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, haematologic, psychiatric or metabolic disturbances
  • severe restriction of respiratory function
  • treatment with MAO inhibitors during the last four weeks
  • active skin disease or skin irritation at designated patch locations
  • history of chronic pain (episodes of more than three months of chronic pain)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

FentanylBuprenorphineNaloxone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Janssen-Cilag A.G. Clinical Trial

    Janssen-Cilag A.G.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 22, 2009

Study Start

November 1, 2004

Study Completion

January 1, 2005

Last Updated

June 22, 2010

Record last verified: 2010-06