NCT00237341

Brief Summary

The purpose of this study is to assess physical functionality changes over a minimum of 9 weeks in patients with non-malignant chronic low back pain who are taking short-acting opioids (narcotic pain medications) for 4 or more weeks, and who start taking the long-acting opioid fentanyl in the form of a transdermal (skin) patch.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
358

participants targeted

Target at P75+ for phase_4 low-back-pain

Timeline
Completed

Started Jun 2002

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

June 1, 2002

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
1.8 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

November 20, 2013

Status Verified

November 1, 2013

First QC Date

October 7, 2005

Last Update Submit

November 19, 2013

Conditions

Low Back Pain

Keywords

chronic low back painopioidfentanyl

Interventions

fentanylDRUG

Eligibility Criteria

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

You may qualify if:

  • Chronic low back pain (not related to cancer) for at least 3 months
  • current use of short-acting opioid (narcotic pain medication) for at least 4 weeks
  • initiating fentanyl transdermal patch.

You may not qualify if:

  • Confusion or reduced level of consciousness
  • skin disease
  • malignancies (cancer)
  • currently hospitalized
  • treated with a long-acting opioid within the last 2 months
  • pregnant or breast-feeding
  • abusing drugs or alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Low Back Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial

    PriCara, Unit of Ortho-McNeil, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

June 1, 2002

Study Completion

January 1, 2004

Last Updated

November 20, 2013

Record last verified: 2013-11