Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

NCT ID: NCT00105287

Last Updated: 2014-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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OraVescent fentanyl (OVF)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cephalon

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cullman Oncology and Hematology

Cullman, Alabama, United States

Site Status

Advanced Clinical Research Institute

Anaheim, California, United States

Site Status

Pacific Cancer Medical Center

Anaheim, California, United States

Site Status

Compassionate Cancer Care Medical Group

Corona, California, United States

Site Status

Compassionate Cancer Center

Fountain Valley, California, United States

Site Status

Clinical Trials & Research Associates, Inc.

Montebello, California, United States

Site Status

San Diego Hospice & Palliative Care

San Diego, California, United States

Site Status

Pacific Clinical Research

Santa Monica, California, United States

Site Status

Lovelace Scientific Resources

Miami, Florida, United States

Site Status

Gulf Coast Pain Specialists

Pensacola, Florida, United States

Site Status

Hematology Oncology Associates of Treasure Coast

Port Saint Lucie, Florida, United States

Site Status

Center for Prospective Outcome

Marietta, Georgia, United States

Site Status

Iowa Pain Management Clinic, PC

Des Moines, Iowa, United States

Site Status

Donald Berdeaux

Great Falls, Montana, United States

Site Status

Great Falls Clinic, LLP

Great Falls, Montana, United States

Site Status

Southern Nevada Cancer Research

Las Vegas, Nevada, United States

Site Status

NYU Pain Management Center

New York, New York, United States

Site Status

Research Across America

New York, New York, United States

Site Status

Brody School of Medicine

Greenville, North Carolina, United States

Site Status

Gabrail Cancer Center

Canton, Ohio, United States

Site Status

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Charleston Hematology Oncology, PA

Charleston, South Carolina, United States

Site Status

University of Rochester

San Antonio, Texas, United States

Site Status

Lifetree Clinical Research

Salt Lake City, Utah, United States

Site Status

Cache Valley Cancer Treatment and Research Clinic, Inc.

West Point, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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C25608/3039/BP/US

Identifier Type: -

Identifier Source: org_study_id

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