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Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain

Primary Purpose

Pain

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 Pain focused on measuring diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia, chronic pancreatitis, osteoarthritis

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, barrier method with spermicide, steroidal contraceptive [oral, transdermal, implanted, and 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 pain of at least 3 months' duration associated with any of the following conditions: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia (documented diagnosis), chronic pancreatitis, or osteoarthritis. Other chronic painful conditions may be evaluated for entry upon discussion with, and written approval from, the Cephalon Medical Monitor. The patient is currently using 1 of the following: at least 60 mg of oral morphine/day, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oxycodone/day, or at least 8 mg of hydromorphone/day, or an equianalgesic dose of another opioid/day as a stable dose of ATC therapy for at least the previous 30 days prior to enrollment in the study. The patient reports an average pain intensity score, over the prior 24 hours, of 6 or less (0=no pain through 10=worst pain) for his/her chronic pain. The patient experiences, on average, 1 to 4 BTP episodes (defined as temporary flares of severe 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, occurring at the location of the chronic pain, and achieves at least partial relief. The patient is able to effectively self-administer the study drug and complete the electronic diary. 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 the chronic pain currently being treated. The patient has a positive urine drug screen (UDS) for a medication not prescribed by the physician currently treating the chronic pain.

Sites / Locations

  • Hot Springs Pain Clinic
  • Samaritan Center for Medical
  • Pacific Neuroscience Medical Group, Inc.
  • Centre for Rheumatology
  • Jacksonville Center for Clinical Research
  • Atlas Research
  • Gold Coast Research, LLC
  • Comprehensive Pain Care, PC
  • Drug Studies America
  • Best Clinical Trials, Inc.
  • Best Clinical Trials, LLC
  • Brigham Women's Hospital
  • Pain Management Associates
  • Montana Neuroscience Institute
  • Lovelace Scientific Resources
  • Five Towns Neuroscience Research
  • PharmQuest
  • Center for Clinical Research
  • Legacy Emanuel Pain Management, PC
  • Clinical Research Center
  • Advanced Pain Management

Outcomes

Primary Outcome Measures

The primary objective is to evaluate the efficacy of OraVescent fentanyl treatment compared with placebo treatment following 12 weeks of treatment in alleviating breakthrough pain (BTP) in opioid-tolerant patients with noncancer-related chronic pain.

Secondary Outcome Measures

Full Information

First Posted
June 21, 2006
Last Updated
May 8, 2014
Sponsor
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00343733
Brief Title
Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain
Official Title
A 12-Week Open-Label Study With 3 Within-Patient Double-Blind Placebo-Controlled Periods to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cephalon

4. Oversight

5. Study Description

Brief Summary
The purpose of the study is to evaluate the efficacy and safety of OraVescent fentanyl treatment compared to placebo treatment monthly over a 12-week treatment period in alleviating breakthrough pain (BTP) in opioid-tolerant patients with noncancer-related chronic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia, chronic pancreatitis, osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
OraVescent Fentanyl
Primary Outcome Measure Information:
Title
The primary objective is to evaluate the efficacy of OraVescent fentanyl treatment compared with placebo treatment following 12 weeks of treatment in alleviating breakthrough pain (BTP) in opioid-tolerant patients with noncancer-related chronic pain.

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, barrier method with spermicide, steroidal contraceptive [oral, transdermal, implanted, and 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 pain of at least 3 months' duration associated with any of the following conditions: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia (documented diagnosis), chronic pancreatitis, or osteoarthritis. Other chronic painful conditions may be evaluated for entry upon discussion with, and written approval from, the Cephalon Medical Monitor. The patient is currently using 1 of the following: at least 60 mg of oral morphine/day, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oxycodone/day, or at least 8 mg of hydromorphone/day, or an equianalgesic dose of another opioid/day as a stable dose of ATC therapy for at least the previous 30 days prior to enrollment in the study. The patient reports an average pain intensity score, over the prior 24 hours, of 6 or less (0=no pain through 10=worst pain) for his/her chronic pain. The patient experiences, on average, 1 to 4 BTP episodes (defined as temporary flares of severe 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, occurring at the location of the chronic pain, and achieves at least partial relief. The patient is able to effectively self-administer the study drug and complete the electronic diary. 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 the chronic pain currently being treated. The patient has a positive urine drug screen (UDS) for a medication not prescribed by the physician currently treating the chronic pain.
Facility Information:
Facility Name
Hot Springs Pain Clinic
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Samaritan Center for Medical
City
Los Gatos
State/Province
California
ZIP/Postal Code
92032
Country
United States
Facility Name
Pacific Neuroscience Medical Group, Inc.
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Centre for Rheumatology
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Atlas Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Gold Coast Research, LLC
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Comprehensive Pain Care, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
Facility Name
Best Clinical Trials, Inc.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70065
Country
United States
Facility Name
Best Clinical Trials, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Brigham Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Pain Management Associates
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055
Country
United States
Facility Name
Montana Neuroscience Institute
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Lovelace Scientific Resources
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Five Towns Neuroscience Research
City
Lawrence
State/Province
New York
ZIP/Postal Code
11599
Country
United States
Facility Name
PharmQuest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Legacy Emanuel Pain Management, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Clinical Research Center
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Advanced Pain Management
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain

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