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OpenTrials
Completed

NCT Number: NCT00228605

Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain

The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl for the potential treatment of breakthrough pain episodes in patients who have chronic noncancer pain.

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Key information

Conditions

Low Back Pain Arthritis Back Pain Brain Diseases Central Nervous System Diseases Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Headache Disorders Headache Disorders, Primary Joint Diseases Migraine Migraine Disorders Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Rheumatic Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

MedSearch, Calera, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic pain diagnosis
  • Opioid tolerant
  • Has on average 1-4 breakthrough pain episodes per day

Exclusion criteria

  • Drug abuse history
  • Cardiopulmonary disease
  • Monoamine oxidase inhibitors (MAOIs)
  • Expected to have surgery to relieve the pain

Treatment and study plan

OraVescent Fentanyl

Drug

Primary outcomes

  1. Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients

Secondary outcomes

  1. Assess the patients' quality of life through questionnaires

  2. Assess the patients' overall medication preferences

  3. Assess the patients' overall medication performance

Sponsors and collaborators

Lead sponsor

Cephalon

Industry

Registry information

Official study title

An Open-Label 12 Month Study to Evaluate the Safety, Tolerability and Efficacy of OraVescent Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Noncancer Pain

Important dates

Study start
2005
Study completion
2007
First posted
Sep 29, 2005
Registry last updated
May 9, 2014

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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