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Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Phase 3
Completed
Conditions
Pain
Cancer
Registration Number
NCT00105287
Lead Sponsor
Cephalon
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (26)

Cullman Oncology and Hematology

πŸ‡ΊπŸ‡Έ

Cullman, Alabama, United States

Advanced Clinical Research Institute

πŸ‡ΊπŸ‡Έ

Anaheim, California, United States

Pacific Cancer Medical Center

πŸ‡ΊπŸ‡Έ

Anaheim, California, United States

Compassionate Cancer Care Medical Group

πŸ‡ΊπŸ‡Έ

Corona, California, United States

Compassionate Cancer Center

πŸ‡ΊπŸ‡Έ

Fountain Valley, California, United States

Clinical Trials & Research Associates, Inc.

πŸ‡ΊπŸ‡Έ

Montebello, California, United States

San Diego Hospice & Palliative Care

πŸ‡ΊπŸ‡Έ

San Diego, California, United States

Pacific Clinical Research

πŸ‡ΊπŸ‡Έ

Santa Monica, California, United States

Lovelace Scientific Resources

πŸ‡ΊπŸ‡Έ

Miami, Florida, United States

Gulf Coast Pain Specialists

πŸ‡ΊπŸ‡Έ

Pensacola, Florida, United States

Scroll for more (16 remaining)
Cullman Oncology and Hematology
πŸ‡ΊπŸ‡ΈCullman, Alabama, United States

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