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


Phase 3
18 Years
80 Years
Not Enrolling
Both
Pain, Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerability and safety of OraVescent fentanyl when used long-term

Authority:

United States: Food and Drug Administration

Study ID:

099-15

NCT ID:

NCT00105937

Start Date:

April 2004

Completion Date:

November 2006

Related Keywords:

  • Pain
  • Cancer
  • Cancer
  • Pain

Name

Location

Beth Israel Medical CenterNew York, New York  10003
North Shore University HospitalManhasset, New York  11030
City of Hope National Medical CenterLos Angeles, California  91010
Hematology Oncology AssociatesAtlantis, Florida  33462
Saint Joseph's Mercy Cancer CenterHot Springs, Arkansas  71913
Arizona Clinical Research CenterTucson, Arizona  85712
St. Agnes HealthcareBaltimore, Maryland  21229
Innovative Medical Research of South FloridaMiami Shores, Florida  33138
Outcomes Research InternationalTucson, Arizona  85711
Hematology and Oncology SpecialistsNew Orleans, Louisiana  70115
Southwest Oncology AssociatesLafayette, Louisiana  70503
Providence Cancer InstituteSouthfield, Michigan  48075
Kentucky Cancer ClinicPikeville, Kentucky  41501
Florida Medical Clinic, PAZephyrhills, Florida  33542
Center for Pain ManagementHuntsville, Alabama  35801
Florida Institute of Medical ResearchJacksonville, Florida  32207
PETC Research Group, Inc.Tulsa, Oklahoma  74137
North Shore Cancer Research AssociationSkokie, Illinois  60076
University of Wisconsin Medical SchoolMadison, Wisconsin  53792-0001
Hot Spring Pain ClinicHot Springs, Arkansas  71913
Arkansas Cancer InstitutePine Bluff, Arkansas  71603
The Cancer Prevention and Treatment CenterSoquel, California  95073
Northwestern Connecticut Oncology & Hematology AssociatesTorrington, Connecticut  06790
University of Florida Shands Cancer Center at JacksonvilleJacksonville, Florida  32209
Gulf Coast Oncology AssociationSt. Petersburg, Florida  33705
Clinical Pharmacology Services, IncTampa, Florida  33617
Palm Beach ResearchWest Palm Beach, Florida  33409
Southeastern Gynecologic Oncology, LLCAtlanta, Georgia  30342
Huron Medical CenterPort Huron, Michigan  48067
Bond Clinic, IncRolla, Missouri  65407
HealthCare Research, LLCSt. Louis, Missouri  63141
The Center for Clinical Research, LLCWinston-Salem, North Carolina  27103
Oncology Associates of OregonEugene, Oregon  97401
Allegheny Pain Management, PCAltoona, Pennsylvania  16601
St. Mary Medical CenterLanghorne, Pennsylvania  19047
Mohamed HaqPasadena, Texas  77504
Cancer Care Centers of South TexasSan Antonio, Texas  78229
UTHCT (ATTN: Clinical Research)Tyler, Texas  75708
Hunstman Cancer InstituteSalt Lake City, Utah  84112
Palliative Care and Pain MedicineSalt Lake City, Utah  84157
Great Basin Clinical ResearchWest Point, Utah  84015
Cancer Outreach Associates, PCAbingdon, Virginia  24211
MedSource IncRichmond, Virginia  23229