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

Sponsor

Cephalon (Industry)

Overall Status

Completed

CT.gov ID

NCT00228605

Collaborator

(none)

500

Enrollment

Locations

Duration (Months)

13.2

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain Migraine Diabetic Neuropathies Osteoarthritis	Drug: OraVescent Fentanyl	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2005

Actual Study Completion Date :

May 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MedSearch	Calera	Alabama	United States	35040
2	Clinical Research Consultants, Inc.	Hoover	Alabama	United States	35216
3	Arizona Research Center	Phoenix	Arizona	United States	85023
4	NEA Clinic	Jonesboro	Arkansas	United States	72404
5	Lynn Institute of the Rockies	Colorado Springs	Colorado	United States	80909
6	Radiant Research-Daytona Beach	Daytona Beach	Florida	United States	32114
7	Advent Clinical Research Centers, Inc.	St. Petersburg	Florida	United States	33703
8	Gold Coast Research	Weston	Florida	United States	33331
9	Center for Prospective Outcome Studies, Inc.	Atlanta	Georgia	United States	30327
10	Advent Clinical Research Centers, Inc.	Atlanta	Georgia	United States	30342
11	Center for Prospective Outcome Studies, Inc.	Marietta	Georgia	United States	30060
12	North Fulton Regional Hospital Pain Center	Roswell	Georgia	United States	30076
13	Carmen Research	Smyrna	Georgia	United States	30080
14	Orthopedic Health Care	Boise	Idaho	United States	83702
15	Medisphere Medical Research Center, LLC	Evansville	Indiana	United States	47714
16	Tri-State Arthritis & Rheumatology Center, LLC	Evansville	Indiana	United States	47714
17	Iowa Pain Management Clinic, PC	Des Moines	Iowa	United States	50265
18	Mid-America Physiatrists, PA	Overland Park	Kansas	United States	66211
19	Capital Clinical Research Associates, LLC	Rockville	Maryland	United States	20852
20	Brigham Women's Hospital, Attn: Pain Trials Center	Boston	Massachusetts	United States	02115
21	MedVadis Research	Wellesley Hills	Massachusetts	United States	02481-2106
22	Medex Healthcare Research Center	St. Louis	Missouri	United States	63108
23	Radiant Research - St. Louis	St. Louis	Missouri	United States	63141
24	Clinical Research Center of Nevada	Las Vegas	Nevada	United States	89104
25	Northshore University Hospital	Beth Page	New York	United States	11714
26	NYU Pain Management Center	New York	New York	United States	10016
27	Research Across America	New York	New York	United States	10022
28	The Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
29	Southern Oregon Health & Wellness	Medford	Oregon	United States	97504
30	Clinical Research Center of Reading, LLP	West Reading	Pennsylvania	United States	19611
31	Healthstar Physicians	Morristown	Tennessee	United States	37813
32	Biopharma Research Associates	Sugar Land	Texas	United States	77479
33	Lifetree Clinical Research	Salt Lake City	Utah	United States	84106
34	Radiant Research	Salt Lake City	Utah	United States	84107
35	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112
36	Pain Management Center	South Burlington	Vermont	United States	05403
37	Northwest Clinical Research Center	Bellevue	Washington	United States	98004
38	Rowan Research	Spokane	Washington	United States	99207