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Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain

Primary Purpose

Chronic Neuropathic Pain

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 Chronic Neuropathic Pain

Eligibility Criteria

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

Inclusion Criteria: Patients are included in the study if all of the following criteria are met: The patient is willing to provide written informed consent to participate in this study. The patient is 18 through 80 years of age. Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of birth control (ie, barried method with spermicide, steroidal contraceptive [oral, transdermal, implanted, or injected contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD]) and agree to continued use of this method for the duration of the study. The patient has chronic neuropathic pain of at least 3 months duration associated with any of the following conditions: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, or complex regional pain syndrome. Patients with other neuropathic pain etiologies may qualify for the study with permission from the Cephalon medical monitor or designee. The patient is currently using 1 of the following: at least 60 mg of oral morphine/day, or at least 25 mcg transdermal fentanyl/hour, or atleast 30 mg or oxycodone/day, or at least 8 mg hydromorphone/day, or an equianalgesic dose of another opioid/day as a stable dose of around-the-close (ATC) therapy for at least the previous 7 days before enrollment in the study. The patient reports an average pain intensity (PI) score, over the prior 24 hours, of less than 7 (0=no pain through 10=worst pain) for their chronic neuropathic pain. The patient experiences, on average, 1 to 4 BTP episodes (defined as temporary flares of sever or excruciating pain) per day while taking ATC opioid therapy, and on average, the duration of each BTP episode is less than 4 hours. The patient currently uses opioid therapy for alleviation of BTP episodes, occuring at the location of the chronic pain, and achieves at least partial relief. The patient is able to effectively self-administer the study drug. Exclusion Criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met: The patient has uncontrolled or rapidly escalating pain as determined by the investigator (ie, the ATC therapy may be expected to change between the first and last treatments with study drug), or has pain uncontrolled by therapy that could adversely impact the safety of the patient or that could be compromised by treatment with study drug. The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in the study drug. The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse. The patient has cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with potent synthetic opioids. The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data. The patient is expected to have surgery during the study and it is anticipated that the surgery will alleviate the patient's pain. The patient has had therapy before study drug treatment that, in the opinion of the investigator, could alter pain or response to pain medication. The patient is pregnant or lactating. The patient has participated in a previous study with ORAVESCENT fentanyl. The patient has participated in a study involving an investigational drug in the previous 30 days. The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug. The patient has any other medical condition or is receiving concomitant medication/therapy (eg, regional nerve block) that would, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data. The patient is involved in active litigation in regard to their chronic pain. The patient has a positive urin screen (UDS) for a medication not prescribed by their physician or no reasonable explanation can be provided to the Cephalon medical monitor.

Sites / Locations

  • Clopton Clinic
  • Vertex Clinical Research, Inc.
  • San Diego Arthritis Medical
  • Clinical Research of W Florida
  • Florida Institute of Medical R
  • Clinical Pharmacology Services
  • Gold Coast Research
  • Center for Prospective Outcome
  • Georgia Medical Research
  • American Medical Research
  • American Medical Research
  • American Medical Research
  • Iowa Pain Management Clinic, P
  • Mid America Physiatrists, PA
  • Best Clinical Trial, Inc.
  • PharmQuest
  • Northwest Clinical Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
May 8, 2014
Sponsor
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00214955
Brief Title
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain
Official Title
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Neuropathic Pain
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant Patients with Chronic Neuropathic Pain

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ORAVESCENT Fentanyl Citrate

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: Patients are included in the study if all of the following criteria are met: The patient is willing to provide written informed consent to participate in this study. The patient is 18 through 80 years of age. Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of birth control (ie, barried method with spermicide, steroidal contraceptive [oral, transdermal, implanted, or injected contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD]) and agree to continued use of this method for the duration of the study. The patient has chronic neuropathic pain of at least 3 months duration associated with any of the following conditions: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, or complex regional pain syndrome. Patients with other neuropathic pain etiologies may qualify for the study with permission from the Cephalon medical monitor or designee. The patient is currently using 1 of the following: at least 60 mg of oral morphine/day, or at least 25 mcg transdermal fentanyl/hour, or atleast 30 mg or oxycodone/day, or at least 8 mg hydromorphone/day, or an equianalgesic dose of another opioid/day as a stable dose of around-the-close (ATC) therapy for at least the previous 7 days before enrollment in the study. The patient reports an average pain intensity (PI) score, over the prior 24 hours, of less than 7 (0=no pain through 10=worst pain) for their chronic neuropathic pain. The patient experiences, on average, 1 to 4 BTP episodes (defined as temporary flares of sever or excruciating pain) per day while taking ATC opioid therapy, and on average, the duration of each BTP episode is less than 4 hours. The patient currently uses opioid therapy for alleviation of BTP episodes, occuring at the location of the chronic pain, and achieves at least partial relief. The patient is able to effectively self-administer the study drug. Exclusion Criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met: The patient has uncontrolled or rapidly escalating pain as determined by the investigator (ie, the ATC therapy may be expected to change between the first and last treatments with study drug), or has pain uncontrolled by therapy that could adversely impact the safety of the patient or that could be compromised by treatment with study drug. The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in the study drug. The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse. The patient has cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with potent synthetic opioids. The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data. The patient is expected to have surgery during the study and it is anticipated that the surgery will alleviate the patient's pain. The patient has had therapy before study drug treatment that, in the opinion of the investigator, could alter pain or response to pain medication. The patient is pregnant or lactating. The patient has participated in a previous study with ORAVESCENT fentanyl. The patient has participated in a study involving an investigational drug in the previous 30 days. The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug. The patient has any other medical condition or is receiving concomitant medication/therapy (eg, regional nerve block) that would, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data. The patient is involved in active litigation in regard to their chronic pain. The patient has a positive urin screen (UDS) for a medication not prescribed by their physician or no reasonable explanation can be provided to the Cephalon medical monitor.
Facility Information:
Facility Name
Clopton Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Vertex Clinical Research, Inc.
City
Bakersfield
State/Province
California
ZIP/Postal Code
93311
Country
United States
Facility Name
San Diego Arthritis Medical
City
San Diego
State/Province
California
ZIP/Postal Code
92106
Country
United States
Facility Name
Clinical Research of W Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Florida Institute of Medical R
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Clinical Pharmacology Services
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
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
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Georgia Medical Research
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
American Medical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
American Medical Research
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
American Medical Research
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Iowa Pain Management Clinic, P
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
Best Clinical Trial, Inc.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
PharmQuest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Northwest Clinical Research
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

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Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain

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