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Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

This study has been completed.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon ) Identifier:
First received: March 11, 2005
Last updated: May 8, 2014
Last verified: May 2014
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 Intervention Phase
Pain Cancer Drug: OraVescent fentanyl (OVF) Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceutical Industries ( Cephalon ):

Estimated Enrollment: 100
Study Start Date: January 2005
Study Completion Date: September 2007
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00105287

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Sponsors and Collaborators
  More Information

Responsible Party: Cephalon Identifier: NCT00105287     History of Changes
Other Study ID Numbers: C25608/3039/BP/US
Study First Received: March 11, 2005
Last Updated: May 8, 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
Anesthetics processed this record on August 23, 2017