Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain
CompletedPhase 3NCT00228605
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official 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
- Interventions
- Drug: OraVescent Fentanyl
- Sponsor
- Cephalon
- Organization
- Teva Branded Pharmaceutical Products R&D, Inc.
- Start date
- 2005-03
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 38
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00228605