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Chronic Neuropathic PainPhase 3NCT00214955

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

A Phase 3 study testing ORAVESCENT Fentanyl Citrate in people with Chronic Neuropathic Pain, run by Cephalon at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Neuropathic Pain
What is being tested?
ORAVESCENT Fentanyl Citrate
How many people
120 participants
Where
17 sitesUnited States
Study dates
Sep 2005to May 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Vertex Clinical Research, Inc.

    Bakersfield, California, 93311

  • Northwest Clinical Research

    Bellevue, Washington, 98004

  • American Medical Research

    Chicago, Illinois, 60616

  • Clinical Research of W Florida

    Clearwater, Florida, 33765

  • Iowa Pain Management Clinic, P

    Des Moines, Iowa, 50265

  • PharmQuest

    Greensboro, North Carolina, 27401

  • Florida Institute of Medical R

    Jacksonville, Florida, 32207

  • Clopton Clinic

    Jonesboro, Arkansas, 72401

  • Center for Prospective Outcome

    Marietta, Georgia, 30060

  • Georgia Medical Research

    Marietta, Georgia, 30060

  • Best Clinical Trial, Inc.

    New Orleans, Louisiana, 70115

  • American Medical Research

    Oak Brook, Illinois, 60523

  • Mid America Physiatrists, PA

    Overland Park, Kansas, 66211

  • San Diego Arthritis Medical

    San Diego, California, 92106

  • Clinical Pharmacology Services

    Tampa, Florida, 33617

  • American Medical Research

    Valparaiso, Indiana, 46383

  • Gold Coast Research

    Weston, Florida, 33331

Other trials in United States

About this study

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

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

Being tested
ORAVESCENT Fentanyl Citrate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ORAVESCENT Fentanyl CitrateDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Enrolment
120 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00214955
Sponsor's protocol ID
C25608/3041/BP/US
Status last verified
May 2014
First submitted
14 Sep 2005
Last updated
9 May 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ORAVESCENT Fentanyl Citrate in people with Chronic Neuropathic Pain, run by Cephalon at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00214955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2014.

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