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


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

This study is currently recruiting patients.

Sponsored by: Cephalon
Information provided by: Cephalon

Purpose

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.

Condition Treatment or Intervention Phase
Pain
Cancer
  Drug: OraVescent fentanyl citrate
 Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Pain

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: Tolerability and safety of OraVescent fentanyl when used long-term
Secondary Outcomes: Assess the effectiveness of OraVescent fentanyl; Assess the development of incremental tolerance
Expected Total Enrollment:  300

Study start: April 2004

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.

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

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

Location and Contact Information


Alabama
      Center for Pain Management, Huntsville,  Alabama,  35801,  United States; Recruiting
Carol Weston  256-265-7248 
John Roberts, MD,  Principal Investigator

Arizona
      Arizona Clinical Research Center, Tucson,  Arizona,  85712,  United States; Recruiting
Sue Logsdon  520-290-2510    slogsdon@acrcresearch.com 
Donald Brooks, MD,  Principal Investigator

      Outcomes Research International, Tucson,  Arizona,  85711,  United States; Recruiting
Chris Arslanian  520-514-7600    ArslanPhD@aol.com 
Larry Putnam, MD,  Principal Investigator

Arkansas
      Hot Spring Pain Clinic, Hot Springs,  Arkansas,  71913,  United States; Recruiting
Mandy Young  501-321-4772    research@cablelynx.com 
Jacob Abraham, MD,  Principal Investigator

      Arkansas Cancer Institute, Pine Bluff,  Arkansas,  71603,  United States; Recruiting
June Long  870-919-5984    jlong@clinicalresearchconnections.com 
Asif Masood, MD,  Principal Investigator

      Saint Joseph's Mercy Cancer Center, Hot Springs,  Arkansas,  71913,  United States; Recruiting
Karen Bolton  501-622-4700    kboltonrn@aol.com 
David Pruitt, MD,  Principal Investigator

      Saint Joseph's Mercy Cancer Center, Hot Springs,  Arkansas,  71913,  United States; Recruiting
Karen Bolton  501-622-4700    kboltonrn@aol.com 
Prabhakara Reddy, MD,  Principal Investigator

California
      The Cancer Prevention and Treatment Center, Soquel,  California,  95073,  United States; Recruiting
Cecilia Rivas  831-462-8750    cecy@cybercancer.com 
J. Talisman Pomeroy, MD,  Principal Investigator

      City of Hope National Medical Center, Duarte,  California,  91010,  United States; Recruiting
Chantal Kerr  626-359-8111    ckerr@coh.org 
Neal Slatkin, MD,  Principal Investigator

Connecticut
      Northwestern Connecticut Oncology & Hematology Associates, Torrington,  Connecticut,  06790,  United States; Recruiting
Roberta Votino  860-482-5384    rvotino@nwctoncology.com 
Debra Brandt, DO,  Principal Investigator

Florida
      Clinical Pharmacology Services, Inc, Tampa,  Florida,  33617,  United States; Recruiting
Pat Dyches  813-983-1500    pdyches@cpshealth.com 
Daniel Buffington, Pharm D.,  Principal Investigator

      Florida Institute of Medical Research, Jacksonville,  Florida,  32207,  United States; Recruiting
Joy Elliot  904-306-9995    jelliott@theipm.com 
Florete Orlando, MD,  Principal Investigator

      University of Florida Shands Cancer Center at Jacksonville, Jacksonville,  Florida,  32209,  United States; Recruiting
Joyce Willis  904-244-1103    joyce.willis@jax.ufl.edu 
Troy Guthrie, MD,  Principal Investigator

      Florida Medical Clinic, PA, Zephyrhills,  Florida,  33542,  United States; Recruiting
Bill Thompson  813-780-8368    bthompson@floridamedicalclinic.com 
Ronald Kawauchi, MD,  Principal Investigator

      Innovative Medical Research of South Florida, Miami Shores,  Florida,  33138,  United States; Recruiting
Louis Saltzman  305-759-1881    innmed1@aol.com 
Marc Saltzman, MD,  Principal Investigator

      Hematology Oncology Associates, Lake Worth,  Florida,  33461-4710,  United States; Recruiting
Tom Voulgaris  561-964-2662    tom.voulgaris@hcahealthcare.com 
James Weick, MD,  Principal Investigator

      Palm Beach Research, West Palm Beach,  Florida,  33409,  United States; Recruiting
Marlene Church  561-689-0606    marlene@palmbeachresearch.com 
Harlan Bieley, MD,  Principal Investigator

      Gulf Coast Oncology Association, St. Petersburg,  Florida,  33705,  United States; Recruiting
Margie Blazek  727-821-0017 
Joseph Mace, MD,  Principal Investigator

Georgia
      Southeastern Gynecologic Oncology, LLC, Atlanta,  Georgia,  30342,  United States; Recruiting
Penny Daugherty  678-420-4154    pdaugherty@segynonc.com 
Jeffrey Hines, MD,  Principal Investigator

Illinois
      North Shore Cancer Research Association, Skokie,  Illinois,  60076,  United States; Recruiting
Darilyn Rhoades  847-675-3900 
Edward Kaplan, MD,  Principal Investigator

Kentucky
      Kentucky Cancer Clinic, Hazard,  Kentucky,  41701,  United States; Recruiting
Denise Queen  606-439-2239    dqueen@setel.com 
Hassan Ghazal, MD,  Principal Investigator

Louisiana
      Southwest Oncology Associates, Lafayette,  Louisiana,  70503,  United States; Recruiting
Marleen King  337-234-4535    marleenking@swonc.com 
Meza Luis A., MD,  Principal Investigator

      Hematology and Oncology Specialists, New Orleans,  Louisiana,  70115,  United States; Recruiting
Allison Kron-Berkowitz  504-894-7115    ssonnier@salco.net 
Scott Sonnier, MD,  Principal Investigator

Maryland
      St. Agnes Healthcare, Baltimore,  Maryland,  21229,  United States; Recruiting
Sheetal Vinayek  410-368-8619    svinayek@stagnes.org 
Armando Sardi, MD,  Principal Investigator

Michigan
      Providence Cancer Institute, Southfield,  Michigan,  48075,  United States; Recruiting
Jaswinder Grewal  248-849-5337    jaswinder.grewal@providence-stjohnhealth.org 
Howard Terebelo, MD,  Principal Investigator

      Huron Medical Center, Port Huron,  Michigan,  48067,  United States; Recruiting
Karen Pfaff  810-982-5200 
Youssef Hanna, MD,  Principal Investigator

Missouri
      Bond Clinic, Inc, Rolla,  Missouri,  65407,  United States; Recruiting
Rhonda Drewel  573-364-8823    rhonda@bondclinicinc.com 
Vinay Raja, MD,  Principal Investigator

      HealthCare Research, LLC, St. Louis,  Missouri,  63141,  United States; Recruiting
Brian Springer  314-432-8035    subq22@hotmail.com 
Andrea Baxter, MD,  Principal Investigator

New York
      Beth Israel Medical Center, New York,  New York,  10003,  United States; Recruiting
Lorraine Manco  212-844-1481    lmanco@chpnet.org 
Russell Portenoy, MD,  Principal Investigator

      North Shore University Hospital, Manhasset,  New York,  11030,  United States; Recruiting
Barbara Barile-Thiem  516-562-8900 
James D'Olimpio, MD,  Principal Investigator

North Carolina
      The Center for Clinical Research, LLC, Winston Salem,  North Carolina,  27103,  United States; Recruiting
John Darnell  336-714-8389    jdarnell@ccrpain.com 
Richard Rauck, MD,  Principal Investigator

Oklahoma
      PETC Research Group, Inc., Tulsa,  Oklahoma,  74137,  United States; Recruiting
Lisa Vaughn  918-477-9381 
Raymond Sorensen, MD,  Principal Investigator

Oregon
      Oncology Associates of Oregon, Eugene,  Oregon,  97401,  United States; Recruiting
Virginia Valentin  541-681-4930    virginia.valentin@usoncology.com 
Gary Lee, MD,  Principal Investigator

Pennsylvania
      Allegheny Pain Management, PC, Altoona,  Pennsylvania,  16601,  United States; Recruiting
Lori Letcher  814-946-7798    lletcher@altoonahospital.org 
Michael Drass, MD,  Principal Investigator

      St. Mary Medical Center, Langhorne,  Pennsylvania,  19047,  United States; Recruiting
Christine Armetta  215-710-5328    carmetta@che-east.org 
Robert Reilly, MD,  Principal Investigator

Texas
      Mohamed Haq, Pasadena,  Texas,  77504,  United States; Recruiting
Mazher Jaweed  713-628-8897    mazher.jaweed@neeman-medical.com 
Mohamed Haq, MD,  Principal Investigator

      UTHCT (ATTN: Clinical Research), Tyler,  Texas,  75708,  United States; Recruiting
Nancy Creech  903-877-7349    nancy.creech@uthct.edu 
Rafael Gallardo, MD,  Principal Investigator

      Cancer Care Centers of South Texas, San Antonio,  Texas,  78229,  United States; Recruiting
Annelies Burnley  210-595-5324    annelies.burnley@usoncology.com 
Gregory Guzley, MD,  Principal Investigator

Utah
      Palliative Care and Pain Medicine, Salt Lake City,  Utah,  84157,  United States; Recruiting
Karen George  801-288-0607    kgeorge@wasatchcrc.com 
Greg Miller, MD,  Principal Investigator

      Great Basin Clinical Research, West Point,  Utah,  84015,  United States; Recruiting
Carrie Briscoe  801-525-8837    cabriscoe@msn.com 
Michael Jacobson, MD,  Principal Investigator

      Hunstman Cancer Institute, Salt Lake City,  Utah,  84112,  United States; Recruiting
Deborah Thorpe  801-585-0244    deborah.thorpe@hci.utah.edu 
Sharon Weinstein, MD,  Principal Investigator

Virginia
      Cancer Outreach Associates, PC, Abingdon,  Virginia,  24211,  United States; Recruiting
Karen Taylor  279-676-1863    ktaylor@canceroutreach.com 
Forrest Swan, MD,  Principal Investigator

      MedSource Inc, Richmond,  Virginia,  23229,  United States; Recruiting
Joanne Sydnor  804-282-9501    jsydnor@medsourceresearch.com 
G. Dastigar Qureshi, MD,  Principal Investigator

Wisconsin
      University of Wisconsin Medical School, Madison,  Wisconsin,  53792-5669,  United States; Recruiting
Renae Quale  608-265-2789    qualere@biostat.wisc.edu 
James Cleary, MD,  Principal Investigator

More Information

Study ID Numbers:  099-15
Record last reviewed:  March 2005
Last Updated:  March 18, 2005
Record first received:  March 18, 2005
ClinicalTrials.gov Identifier:  NCT00105937
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 18, 2008


Page Updated: June 1, 2005
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