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
Drug: OraVescent fentanyl (OVF)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00105287

  Show 26 Study Locations
Sponsors and Collaborators
  More Information

Responsible Party: Teva Pharmaceutical Industries ( 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
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Breakthrough Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Adjuvants, Anesthesia
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 24, 2016