NCT00236327

Brief Summary

The purpose of this study is to determine the safety and efficacy of pain control by fentanyl, administered via adhesive skin patches, at doses of 25 to 100 micrograms per hour in 80 out-patients with intense chronic cancer pain. Higher doses are allowed by permission of the investigator and rescue oral morphine medication is allowed.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Jun 2003

Status
terminated

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

June 1, 2003

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
Last Updated

May 17, 2011

Status Verified

April 1, 2010

First QC Date

October 7, 2005

Last Update Submit

May 16, 2011

Conditions

Pain

Keywords

FentanylAnalgesiaPainCancer painOpioid analgesiaTransdermal fentanylPatient-controlled analgesia

Outcome Measures

Primary Outcomes (1)

  • Pain control level using a visual analog scale (VAS) at various time points and at the end of 56-day study. Percent pain reduction and percentage of patients having a score of 4 or lower compared to the baseline. Use of rescue medication.

Secondary Outcomes (1)

  • Constipation and recorded use of laxatives, patient-assessed quality of life obtained by questionnaires and overall tolerance assessed at the end of 56-day study.

Interventions

fentanylDRUG

Eligibility Criteria

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

You may qualify if:

  • Less than a month of opioid treatment over the past 3 months
  • Proven cancer and chronic stable, cancer-related pain
  • Pain control medication (aside from opioids) at the maximum authorized dose in the 24-hours preceding the first study visit
  • A pain score of at least 4 on the VAS scale and pain that justifies intervention by opium-derived drugs in the opinion of the investigator

You may not qualify if:

  • Liver or kidney problems
  • Previous heart, lung or nervous disorders
  • Allergy to fentanyl
  • Skin condition that might interfere with absorption of the fentanyl through the skin
  • Surgery or chemotherapy in the month preceding the study or scheduled during the 56 days of the study
  • History of substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

PainAgnosiaCancer Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Janssen-Cilag S.A.S. Clinical Trial

    Janssen Cilag S.A.S.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

June 1, 2003

Study Completion

May 1, 2004

Last Updated

May 17, 2011

Record last verified: 2010-04