Clinical Trials Directory

Trials / Completed

CompletedNCT00343733

Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain

A 12-Week Open-Label Study With 3 Within-Patient Double-Blind Placebo-Controlled Periods to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
120 (planned)
Sponsor
Cephalon · Industry
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The purpose of the study is to evaluate the efficacy and safety of OraVescent fentanyl treatment compared to placebo treatment monthly over a 12-week treatment period in alleviating breakthrough pain (BTP) in opioid-tolerant patients with noncancer-related chronic pain.

Conditions

Interventions

TypeNameDescription
DRUGOraVescent Fentanyl

Timeline

Start date
2006-08-01
Completion
2007-07-01
First posted
2006-06-23
Last updated
2014-05-09

Locations

21 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00343733. Inclusion in this directory is not an endorsement.

Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pa (NCT00343733) · Clinical Trials Directory