NCT00269737

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of continuous use of TTS fentanyl (a transdermal patch delivering the narcotic pain reliever fentanyl) for the treatment of chronic cancer pain.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_3 pain

Timeline
Completed

Started May 1986

Typical duration for phase_3 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

May 1, 1986

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 1988

Completed
17.9 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 26, 2005

Completed
Last Updated

May 19, 2011

Status Verified

April 1, 2010

First QC Date

December 22, 2005

Last Update Submit

May 18, 2011

Conditions

PainCancer

Keywords

fentanylpainCancerpatch

Outcome Measures

Primary Outcomes (1)

  • Pain intensity at designated time intervals

Secondary Outcomes (1)

  • Pharmacokinetics; Incidence of adverse events

Interventions

Fentanyl Transdermal Therapeutic System (TTS)DRUG

Eligibility Criteria

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

You may qualify if:

  • Patients with a diagnosis of intermediate stage of malignancy, operationally defined as non-localized or metastatic disease causing moderate to severe pain
  • Having a diagnosis of terminal disease, defined as life expectancy of six months or less, with moderate to severe pain associated with malignancy
  • Requiring treatment with a narcotic analgesic for relief of cancer pain
  • Having normal liver, kidney, and lung function, as determined by liver function tests, BUN, creatinine, and blood gases

You may not qualify if:

  • Patients with a history of allergic reaction to narcotics
  • Having a history of narcotic abuse prior to cancer diagnosis
  • Unable to communicate adequately to provide information assessing the effectiveness of treatment
  • Having active skin disease which precludes application of the transdermal system
  • Having a history of carbon dioxide (CO2) retention or respiratory problems and who, in the physician's judgment, should not use narcotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

PainNeoplasms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alza Corporation Clinical Trial

    Alza Corporation, DE, USA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 22, 2005

First Posted

December 26, 2005

Study Start

May 1, 1986

Study Completion

February 1, 1988

Last Updated

May 19, 2011

Record last verified: 2010-04