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Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain

Primary Purpose

Low Back Pain, Migraine, Diabetic Neuropathies

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

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Pain, Sudden Pain, Flares, noncancer, low back pain, neuropathic pain, osteoarthritis pain, migraine, chronic headache, diabetic peripheral neuropathy

Eligibility Criteria

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

Inclusion Criteria: Chronic pain diagnosis Opioid tolerant Has on average 1-4 breakthrough pain episodes per day Exclusion Criteria: Drug abuse history Cardiopulmonary disease Monoamine oxidase inhibitors (MAOIs) Expected to have surgery to relieve the pain

Sites / Locations

  • MedSearch
  • Clinical Research Consultants, Inc.
  • Arizona Research Center
  • NEA Clinic
  • Lynn Institute of the Rockies
  • Radiant Research-Daytona Beach
  • Advent Clinical Research Centers, Inc.
  • Gold Coast Research
  • Center for Prospective Outcome Studies, Inc.
  • Advent Clinical Research Centers, Inc.
  • Center for Prospective Outcome Studies, Inc.
  • North Fulton Regional Hospital Pain Center
  • Carmen Research
  • Orthopedic Health Care
  • Medisphere Medical Research Center, LLC
  • Tri-State Arthritis & Rheumatology Center, LLC
  • Iowa Pain Management Clinic, PC
  • Mid-America Physiatrists, PA
  • Capital Clinical Research Associates, LLC
  • Brigham Women's Hospital, Attn: Pain Trials Center
  • MedVadis Research
  • Medex Healthcare Research Center
  • Radiant Research - St. Louis
  • Clinical Research Center of Nevada
  • Northshore University Hospital
  • NYU Pain Management Center
  • Research Across America
  • The Lynn Health Science Institute
  • Southern Oregon Health & Wellness
  • Clinical Research Center of Reading, LLP
  • Healthstar Physicians
  • Biopharma Research Associates
  • Lifetree Clinical Research
  • Radiant Research
  • Huntsman Cancer Institute
  • Pain Management Center
  • Northwest Clinical Research Center
  • Rowan Research

Outcomes

Primary Outcome Measures

Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients

Secondary Outcome Measures

Assess the patients' quality of life through questionnaires
Assess the patients' overall medication preferences
Assess the patients' overall medication performance

Full Information

First Posted
September 27, 2005
Last Updated
May 8, 2014
Sponsor
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00228605
Brief Title
Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain
Official Title
An Open-Label 12 Month Study to Evaluate the Safety, Tolerability and Efficacy of OraVescent Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Noncancer Pain
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

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 for the potential treatment of breakthrough pain episodes in patients who have chronic noncancer pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Migraine, Diabetic Neuropathies, Osteoarthritis
Keywords
Pain, Sudden Pain, Flares, noncancer, low back pain, neuropathic pain, osteoarthritis pain, migraine, chronic headache, diabetic peripheral neuropathy

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
OraVescent Fentanyl
Primary Outcome Measure Information:
Title
Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients
Secondary Outcome Measure Information:
Title
Assess the patients' quality of life through questionnaires
Title
Assess the patients' overall medication preferences
Title
Assess the patients' overall medication performance

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: Chronic pain diagnosis Opioid tolerant Has on average 1-4 breakthrough pain episodes per day Exclusion Criteria: Drug abuse history Cardiopulmonary disease Monoamine oxidase inhibitors (MAOIs) Expected to have surgery to relieve the pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwendolyn Neibler, DO
Organizational Affiliation
Cephalon
Official's Role
Study Director
Facility Information:
Facility Name
MedSearch
City
Calera
State/Province
Alabama
ZIP/Postal Code
35040
Country
United States
Facility Name
Clinical Research Consultants, Inc.
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
NEA Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72404
Country
United States
Facility Name
Lynn Institute of the Rockies
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Radiant Research-Daytona Beach
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Advent Clinical Research Centers, Inc.
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
Facility Name
Gold Coast Research
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Center for Prospective Outcome Studies, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Advent Clinical Research Centers, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Center for Prospective Outcome Studies, Inc.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
North Fulton Regional Hospital Pain Center
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Carmen Research
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Orthopedic Health Care
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Medisphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Tri-State Arthritis & Rheumatology Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
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
Mid-America Physiatrists, PA
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Capital Clinical Research Associates, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Brigham Women's Hospital, Attn: Pain Trials Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
MedVadis Research
City
Wellesley Hills
State/Province
Massachusetts
ZIP/Postal Code
02481-2106
Country
United States
Facility Name
Medex Healthcare Research Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Radiant Research - St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Northshore University Hospital
City
Beth Page
State/Province
New York
ZIP/Postal Code
11714
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
10022
Country
United States
Facility Name
The Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Southern Oregon Health & Wellness
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Clinical Research Center of Reading, LLP
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Healthstar Physicians
City
Morristown
State/Province
Tennessee
ZIP/Postal Code
37813
Country
United States
Facility Name
Biopharma Research Associates
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Radiant Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Pain Management Center
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Rowan Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain

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