Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

This study has been completed.
Information provided by:
Cephalon Identifier:
First received: March 11, 2005
Last updated: September 11, 2006
Last verified: September 2006

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 Cephalon:

Estimated Enrollment: 100
Study Start Date: February 2004

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
Please refer to this study by its identifier: NCT00105287

  Show 26 Study Locations
Sponsors and Collaborators
  More Information

No publications provided Identifier: NCT00105287     History of Changes
Other Study ID Numbers: C25608/3039/BP/US
Study First Received: March 11, 2005
Last Updated: September 11, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Cephalon:
Breakthrough Pain in cancer patients

Additional relevant MeSH terms:
Analgesics, Opioid
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics processed this record on April 16, 2014