OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

June 27, 2012 updated by: Cephalon

Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

The purpose of this study is to evaluate the long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of this study is to determine the tolerability and safety of OraVescent fentanyl when used long term to relieve breakthrough pain in opioid tolerant cancer patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Center for Pain Management
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Center
      • Tucson, Arizona, United States, 85711
        • Outcomes Research International
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Saint Joseph's Mercy Cancer Center
      • Hot Springs, Arkansas, United States, 71913
        • Hot Spring Pain Clinic
      • Pine Bluff, Arkansas, United States, 71603
        • Arkansas Cancer Institute
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Soquel, California, United States, 95073
        • The Cancer Prevention and Treatment Center
    • Connecticut
      • Torrington, Connecticut, United States, 06790
        • Northwestern Connecticut Oncology & Hematology Associates
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Florida Institute of Medical Research
      • Jacksonville, Florida, United States, 32209
        • University of Florida Shands Cancer Center at Jacksonville
      • Lake Worth, Florida, United States, 33461-4710
        • Hematology Oncology Associates
      • Miami Shores, Florida, United States, 33138
        • Innovative Medical Research of South Florida
      • St. Petersburg, Florida, United States, 33705
        • Gulf Coast Oncology Association
      • Tampa, Florida, United States, 33617
        • Clinical Pharmacology Services, Inc
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, PA
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Southeastern Gynecologic Oncology, LLC
    • Illinois
      • Skokie, Illinois, United States, 60076
        • North Shore Cancer Research Association
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Kentucky Cancer Clinic
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Southwest Oncology Associates
      • New Orleans, Louisiana, United States, 70115
        • Hematology and Oncology Specialists
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • St. Agnes Healthcare
    • Michigan
      • Port Huron, Michigan, United States, 48067
        • Huron Medical Center
      • Southfield, Michigan, United States, 48075
        • Providence Cancer Institute
    • Missouri
      • Rolla, Missouri, United States, 65407
        • Bond Clinic, Inc
      • St. Louis, Missouri, United States, 63141
        • Healthcare Research, LLC
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research, LLC
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74137
        • PETC Research Group, Inc.
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oncology Associates of Oregon
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • Allegheny Pain Management, PC
      • Langhorne, Pennsylvania, United States, 19047
        • St. Mary Medical Center
    • Texas
      • Pasadena, Texas, United States, 77504
        • Mohamed Haq
      • San Antonio, Texas, United States, 78229
        • Cancer Care Centers of South Texas
      • Tyler, Texas, United States, 75708
        • UTHCT (ATTN: Clinical Research)
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Hunstman Cancer Institute
      • Salt Lake City, Utah, United States, 84157
        • Palliative Care and Pain Medicine
      • West Point, Utah, United States, 84015
        • Great Basin Clinical Research
    • Virginia
      • Abingdon, Virginia, United States, 24211
        • Cancer Outreach Associates, Pc
      • Richmond, Virginia, United States, 23229
        • MedSource Inc
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-5669
        • University of Wisconsin Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-80 years of age
  • Average of 1-4 breakthrough pain episodes per day
  • Opioid tolerant
  • Histologically documented diagnosis of a malignant solid tumor or hematological malignancy

Exclusion Criteria:

  • Primary breakthrough pain is not related to cancer in any way
  • Opioid or fentanyl intolerance
  • Chronic obstructive pulmonary disease (COPD) or heart disease
  • Sleep apnea or active brain metastases with increased cranial pressure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Tolerability and safety of OraVescent fentanyl when used long-term

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Assess the effectiveness of OraVescent fentanyl
Assess the development of incremental tolerance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cephalon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2004

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 099-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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