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OraVescent Fentanyl (OVF) for the 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 citrate
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

Eligibility Criteria

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

Inclusion Criteria: 18-80 years of age Average of 1-4 breakthrough pain episodes per day Opioid tolerant Histologically documented diagnosis of a malignant solid tumor or hematological malignancy Exclusion Criteria: Primary breakthrough pain is not related to cancer in any way Opioid or fentanyl intolerance Chronic obstructive pulmonary disease (COPD) or heart disease Sleep apnea or active brain metastases with increased cranial pressure

Sites / Locations

  • Center for Pain Management
  • Outcomes Research International
  • Arizona Clinical Research Center
  • Hot Spring Pain Clinic
  • Saint Joseph's Mercy Cancer Center
  • Arkansas Cancer Institute
  • City of Hope National Medical Center
  • The Cancer Prevention and Treatment Center
  • Northwestern Connecticut Oncology & Hematology Associates
  • Florida Institute of Medical Research
  • University of Florida Shands Cancer Center at Jacksonville
  • Hematology Oncology Associates
  • Innovative Medical Research of South Florida
  • Gulf Coast Oncology Association
  • Clinical Pharmacology Services, Inc
  • Palm Beach Research
  • Florida Medical Clinic, PA
  • Southeastern Gynecologic Oncology, LLC
  • North Shore Cancer Research Association
  • Kentucky Cancer Clinic
  • Southwest Oncology Associates
  • Hematology and Oncology Specialists
  • St. Agnes Healthcare
  • Huron Medical Center
  • Providence Cancer Institute
  • Bond Clinic, Inc
  • HealthCare Research, LLC
  • North Shore University Hospital
  • Beth Israel Medical Center
  • The Center for Clinical Research, LLC
  • PETC Research Group, Inc.
  • Oncology Associates of Oregon
  • Allegheny Pain Management, PC
  • St. Mary Medical Center
  • Mohamed Haq
  • Cancer Care Centers of South Texas
  • UTHCT (ATTN: Clinical Research)
  • Hunstman Cancer Institute
  • Palliative Care and Pain Medicine
  • Great Basin Clinical Research
  • Cancer Outreach Associates, PC
  • MedSource Inc
  • University of Wisconsin Medical School

Outcomes

Primary Outcome Measures

Tolerability and safety of OraVescent fentanyl when used long-term

Secondary Outcome Measures

Assess the effectiveness of OraVescent fentanyl
Assess the development of incremental tolerance

Full Information

First Posted
March 18, 2005
Last Updated
June 27, 2012
Sponsor
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00105937
Brief Title
OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Official Title
Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cephalon

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant.
Detailed Description
The objective of this study is to determine the tolerability and safety 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

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
OraVescent fentanyl citrate
Primary Outcome Measure Information:
Title
Tolerability and safety of OraVescent fentanyl when used long-term
Secondary Outcome Measure Information:
Title
Assess the effectiveness of OraVescent fentanyl
Title
Assess the development of incremental tolerance

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: 18-80 years of age Average of 1-4 breakthrough pain episodes per day Opioid tolerant Histologically documented diagnosis of a malignant solid tumor or hematological malignancy Exclusion Criteria: Primary breakthrough pain is not related to cancer in any way Opioid or fentanyl intolerance Chronic obstructive pulmonary disease (COPD) or heart disease Sleep apnea or active brain metastases with increased cranial pressure
Facility Information:
Facility Name
Center for Pain Management
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Outcomes Research International
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Hot Spring Pain Clinic
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Saint Joseph's Mercy Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Arkansas Cancer Institute
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
The Cancer Prevention and Treatment Center
City
Soquel
State/Province
California
ZIP/Postal Code
95073
Country
United States
Facility Name
Northwestern Connecticut Oncology & Hematology Associates
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Facility Name
Florida Institute of Medical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Florida Shands Cancer Center at Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Hematology Oncology Associates
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461-4710
Country
United States
Facility Name
Innovative Medical Research of South Florida
City
Miami Shores
State/Province
Florida
ZIP/Postal Code
33138
Country
United States
Facility Name
Gulf Coast Oncology Association
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Clinical Pharmacology Services, Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Palm Beach Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Florida Medical Clinic, PA
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Southeastern Gynecologic Oncology, LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
North Shore Cancer Research Association
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Kentucky Cancer Clinic
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Southwest Oncology Associates
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Hematology and Oncology Specialists
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
St. Agnes Healthcare
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Huron Medical Center
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48067
Country
United States
Facility Name
Providence Cancer Institute
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Bond Clinic, Inc
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65407
Country
United States
Facility Name
HealthCare Research, LLC
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
The Center for Clinical Research, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
PETC Research Group, Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74137
Country
United States
Facility Name
Oncology Associates of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Allegheny Pain Management, PC
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16601
Country
United States
Facility Name
St. Mary Medical Center
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Mohamed Haq
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77504
Country
United States
Facility Name
Cancer Care Centers of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
UTHCT (ATTN: Clinical Research)
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
Hunstman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Palliative Care and Pain Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
Great Basin Clinical Research
City
West Point
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Cancer Outreach Associates, PC
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States
Facility Name
MedSource Inc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
University of Wisconsin Medical School
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-5669
Country
United States

12. IPD Sharing Statement

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OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

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