Completed PHASE3 NCT00228605

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

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

Sponsor: Cephalon

Conditions Diabetic Neuropathies Low Back Pain Migraine Osteoarthritis

Interventions OraVescent Fentanyl

Updated 7 times since 2017 Last updated: May 8, 2014 Started: Mar 31, 2005 Completion: May 31, 2007

Listed as NCT00228605, this PHASE3 trial focuses on Diabetic Neuropathies and Low Back Pain and remains completed. Sponsored by Cephalon, it has been updated 7 times since 2005, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2022 — Jul 2024 [monthly]

Completed PHASE3
Jan 2021 — Jan 2022 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Mar 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Cephalon

Data source: Teva Branded Pharmaceutical Products R&D, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Atlanta, United States , Bellevue, United States , Bethpage, United States , Boise, United States , Boston, United States , Calera, United States , Colorado Springs, United States , Daytona Beach, United States , Des Moines, United States , Evansville, United States and 22 more locations