NCT00105287

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl when used long-term to relieve breakthrough pain in opioid tolerant cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3 pain

Timeline
Completed

Started Jan 2005

Typical duration for phase_3 pain

Geographic Reach
1 country

26 active sites

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, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

May 9, 2014

Status Verified

May 1, 2014

Enrollment Period

1.7 years

First QC Date

March 11, 2005

Last Update Submit

May 8, 2014

Conditions

PainCancer

Keywords

cancerpainBreakthrough Pain in cancer patients

Interventions

OraVescent fentanyl (OVF)DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented diagnosis of a malignant solid tumor or hematological malignancy causing cancer related pain
  • Currently taking around the clock opioid therapy for pain
  • Experience on average, 1-4 breakthrough pain episodes per day

You may not qualify if:

  • Opioid or fentanyl intolerance
  • Sleep apnea or active brain metastases with increased intracranial pressure
  • COPD (chronic obstructive pulmonary disease); cardiopulmonary disease; heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Cullman Oncology and Hematology

Cullman, Alabama, 35058, United States

Location

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Pacific Cancer Medical Center

Anaheim, California, 92801, United States

Location

Compassionate Cancer Care Medical Group

Corona, California, 92882, United States

Location

Compassionate Cancer Center

Fountain Valley, California, 92708, United States

Location

Clinical Trials & Research Associates, Inc.

Montebello, California, 90640, United States

Location

San Diego Hospice & Palliative Care

San Diego, California, 92103, United States

Location

Pacific Clinical Research

Santa Monica, California, 90404, United States

Location

Lovelace Scientific Resources

Miami, Florida, 33143, United States

Location

Gulf Coast Pain Specialists

Pensacola, Florida, 32503, United States

Location

Hematology Oncology Associates of Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

Center for Prospective Outcome

Marietta, Georgia, 30060, United States

Location

Iowa Pain Management Clinic, PC

Des Moines, Iowa, 50265, United States

Location

Donald Berdeaux

Great Falls, Montana, 59405, United States

Location

Great Falls Clinic, LLP

Great Falls, Montana, 59405, United States

Location

Southern Nevada Cancer Research

Las Vegas, Nevada, 89106, United States

Location

NYU Pain Management Center

New York, New York, 10016, United States

Location

Research Across America

New York, New York, 10021, United States

Location

Brody School of Medicine

Greenville, North Carolina, 27858, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Charleston Hematology Oncology, PA

Charleston, South Carolina, 29403, United States

Location

University of Rochester

San Antonio, Texas, 78229, United States

Location

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

Cache Valley Cancer Treatment and Research Clinic, Inc.

West Point, Utah, 84015, United States

Location

MeSH Terms

Conditions

PainNeoplasms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

March 11, 2005

First Posted

March 14, 2005

Study Start

January 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2007

Last Updated

May 9, 2014

Record last verified: 2014-05

Locations

US(26)