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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00105937
Recruitment Status : Completed
First Posted : March 21, 2005
Last Update Posted : June 29, 2012
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Cancer Drug: OraVescent fentanyl citrate Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Study Start Date : April 2004
Estimated Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Tolerability and safety of OraVescent fentanyl when used long-term

Secondary Outcome Measures :
  1. Assess the effectiveness of OraVescent fentanyl
  2. Assess the development of incremental tolerance


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105937


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Sponsors and Collaborators
Cephalon

ClinicalTrials.gov Identifier: NCT00105937     History of Changes
Other Study ID Numbers: 099-15
First Posted: March 21, 2005    Key Record Dates
Last Update Posted: June 29, 2012
Last Verified: May 2007

Keywords provided by Teva Pharmaceutical Industries:
Cancer
Pain

Additional relevant MeSH terms:
Breakthrough Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Citric Acid
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action