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Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00105287
First Posted: March 14, 2005
Last Update Posted: May 9, 2014
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.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
  Purpose
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)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
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): NCT00105287


  Show 26 Study Locations
Sponsors and Collaborators
Cephalon
  More Information

Responsible Party: Cephalon
ClinicalTrials.gov Identifier: NCT00105287     History of Changes
Other Study ID Numbers: C25608/3039/BP/US
First Submitted: March 11, 2005
First Posted: March 14, 2005
Last Update Posted: May 9, 2014
Last Verified: May 2014

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

Additional relevant MeSH terms:
Breakthrough Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
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