NCT00650182

Brief Summary

The primary objective was to evaluate the safety of D-TRANS fentanyl with naltrexone HCl system compared to the Duragesic (fentanyl transdermal system) in opioid tolerant patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
406

participants targeted

Target at P75+ for phase_2 chronic-pain

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_2 chronic-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

January 1, 2003

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
Last Updated

May 19, 2011

Status Verified

April 1, 2010

First QC Date

March 28, 2008

Last Update Submit

May 18, 2011

Conditions

Chronic Pain

Keywords

patchfentanylchronic pain

Outcome Measures

Primary Outcomes (1)

  • To assess the safety of 2 transdermal formulations of fentanyl (D-TRANS fentanyl with naltrexone transdermal system and Duragesic (fentanyl transdermal system) in patients with chronic pain who were opioid tolerant.

Secondary Outcomes (1)

  • Efficacy assessments included patient global assessments, investigator global assessments, pain intensity, and brief pain inventory. Blood samples were also to be collected for analysis of naltrexone and fentanyl prior to any dose change.

Interventions

fentanyl; naltrexoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of chronic pain who require continuous opioid analgesia
  • Must enter the study on a stable dose of Duragesic for at least 21 days and consent to use a medically acceptable method of contraception throughout the entire study, and for females 1 week after the study is completed and for males 3 months after the study is completed.

You may not qualify if:

  • Skin disease that precluded the use of a transdermal system
  • Clinically significant laboratory abnormalities
  • Significant mental status changes that result in disorientation, memory impairment, or inability to report accurately
  • Illicit drug, prescription drug, or alcohol abuse
  • Cardiopulmonary disease
  • Pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Chronic Pain

Interventions

FentanylNaltrexone

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Alza Corporation Clinical Trial

    ALZA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 1, 2008

Study Start

January 1, 2003

Study Completion

July 1, 2003

Last Updated

May 19, 2011

Record last verified: 2010-04