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Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Primary Purpose

Pain, Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
OraVescent fentanyl (OVF)
Sponsored by
Cephalon
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring cancer, pain, Breakthrough Pain in cancer patients

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cullman Oncology and Hematology
  • Advanced Clinical Research Institute
  • Pacific Cancer Medical Center
  • Compassionate Cancer Care Medical Group
  • Compassionate Cancer Center
  • Clinical Trials & Research Associates, Inc.
  • San Diego Hospice & Palliative Care
  • Pacific Clinical Research
  • Lovelace Scientific Resources
  • Gulf Coast Pain Specialists
  • Hematology Oncology Associates of Treasure Coast
  • Center for Prospective Outcome
  • Iowa Pain Management Clinic, PC
  • Donald Berdeaux
  • Great Falls Clinic, LLP
  • Southern Nevada Cancer Research
  • NYU Pain Management Center
  • Research Across America
  • Brody School of Medicine
  • Gabrail Cancer Center
  • Lehigh Valley Hospital
  • University of Pennsylvania
  • Charleston Hematology Oncology, PA
  • University of Rochester
  • Lifetree Clinical Research
  • Cache Valley Cancer Treatment and Research Clinic, Inc.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 11, 2005
Last Updated
May 8, 2014
Sponsor
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00105287
Brief Title
Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Official Title
Multi-center Study Evaluating OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cephalon

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Cancer
Keywords
cancer, pain, Breakthrough Pain in cancer patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
OraVescent fentanyl (OVF)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cullman Oncology and Hematology
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Pacific Cancer Medical Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Compassionate Cancer Care Medical Group
City
Corona
State/Province
California
ZIP/Postal Code
92882
Country
United States
Facility Name
Compassionate Cancer Center
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Clinical Trials & Research Associates, Inc.
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
San Diego Hospice & Palliative Care
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Pacific Clinical Research
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Lovelace Scientific Resources
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Gulf Coast Pain Specialists
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Hematology Oncology Associates of Treasure Coast
City
Port St. Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Center for Prospective Outcome
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Iowa Pain Management Clinic, PC
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Donald Berdeaux
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Great Falls Clinic, LLP
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Southern Nevada Cancer Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
NYU Pain Management Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Research Across America
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Brody School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Charleston Hematology Oncology, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
University of Rochester
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Cache Valley Cancer Treatment and Research Clinic, Inc.
City
West Point
State/Province
Utah
ZIP/Postal Code
84015
Country
United States

12. IPD Sharing Statement

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Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

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