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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00228605

Enrollment

500

Registered

2005-09-29

Start date

2005-03-31

Completion date

2007-05-31

Last updated

2014-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathies, Low Back Pain, Migraine, Osteoarthritis

Keywords

Pain, Sudden Pain, Flares, noncancer, low back pain, neuropathic pain, osteoarthritis pain, migraine, chronic headache, diabetic peripheral neuropathy

Brief summary

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.

Interventions

DRUGOraVescent Fentanyl

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients	—

Secondary

Measure	Time frame
Assess the patients' quality of life through questionnaires	—
Assess the patients' overall medication preferences	—
Assess the patients' overall medication performance	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026