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OpenTrials
Completed

NCT Number: NCT00105937

OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

The purpose of this study is to evaluate the long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant.

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Key information

Conditions

Pain Cancer Neoplasms Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Center for Pain Management, Huntsville, Alabama, United States

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About this study

The objective of this study is to determine the tolerability and safety of OraVescent fentanyl when used long term to relieve breakthrough pain in opioid tolerant cancer patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-80 years of age
  • Average of 1-4 breakthrough pain episodes per day
  • Opioid tolerant
  • Histologically documented diagnosis of a malignant solid tumor or hematological malignancy

Exclusion criteria

  • Primary breakthrough pain is not related to cancer in any way
  • Opioid or fentanyl intolerance
  • Chronic obstructive pulmonary disease (COPD) or heart disease
  • Sleep apnea or active brain metastases with increased cranial pressure

Treatment and study plan

ORAVESCENT Fentanyl Citrate

Drug

Primary outcomes

  1. Tolerability and safety of OraVescent fentanyl when used long-term

Secondary outcomes

  1. Assess the effectiveness of OraVescent fentanyl

  2. Assess the development of incremental tolerance

Sponsors and collaborators

Lead sponsor

Cephalon

Industry

Registry information

Official study title

Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Important dates

Study start
2004
Study completion
2006
First posted
Mar 21, 2005
Registry last updated
Jun 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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