NCT00269763

Brief Summary

The purpose of this study is to establish the clinical utility and safety of fentanyl TTS (a transdermal patch delivering the narcotic pain reliever fentanyl) in the treatment of pain in patients with cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_3 pain

Timeline
Completed

Started Oct 1987

Shorter than P25 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

October 1, 1987

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 1988

Completed
17.7 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

patchpainfentanylnarcoticCancer

Outcome Measures

Primary Outcomes (1)

  • Assessment of pain relief; Rescue medication usage

Secondary Outcomes (1)

  • Incidence and severity 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 currently taking narcotic analgesics for relief of cancer pain
  • Able to communicate effectively
  • Living with a constant caretaker
  • Who have achieved a stabilized morphine dose that provides adequate pain control

You may not qualify if:

  • Patients with a life expectancy of less than 30 days
  • Having history of carbon dioxide (CO2) retention or other cardiac, respiratory or nervous system disease (precludes participation because of the potential for respiratory depression)
  • Has severe renal or hepatic insufficiency, active skin disease, a history of allergic reactions to narcotics, or a history of narcotic abuse prior to treatment with narcotics for cancer-related pain
  • Has a mental or psychiatric disease
  • If female of child-bearing potential, currently pregnant or not practicing an acceptable method contraception

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

October 1, 1987

Study Completion

April 1, 1988

Last Updated

May 19, 2011

Record last verified: 2010-04