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. Identifier: NCT00105287
Recruitment Status : Completed
First Posted : March 14, 2005
Last Update Posted : May 9, 2014
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl when used long-term to relieve breakthrough pain in opioid tolerant cancer patients.

Condition or disease Intervention/treatment Phase
Pain Cancer Drug: OraVescent fentanyl (OVF) Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center Study Evaluating OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Study Start Date : January 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Inclusion Criteria:

  • Documented diagnosis of a malignant solid tumor or hematological malignancy causing cancer related pain
  • Currently taking around the clock opioid therapy for pain
  • Experience on average, 1-4 breakthrough pain episodes per day

Exclusion Criteria:

  • Opioid or fentanyl intolerance
  • Sleep apnea or active brain metastases with increased intracranial pressure
  • COPD (chronic obstructive pulmonary disease); cardiopulmonary disease; heart disease

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 identifier (NCT number): NCT00105287

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Sponsors and Collaborators

Responsible Party: Cephalon Identifier: NCT00105287     History of Changes
Other Study ID Numbers: C25608/3039/BP/US
First Posted: March 14, 2005    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014

Keywords provided by Teva Pharmaceutical Industries ( Cephalon ):
Breakthrough Pain in cancer patients

Additional relevant MeSH terms:
Breakthrough Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General