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

Tracking Information

First Received Date ^ICMJE

September 27, 2005

Last Updated Date

November 9, 2007

Start Date ^ICMJE

March 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Safety & Tolerability when used over a 12-monthperiod for the maagement of breakthrough pain in opioid tolerant patients

Change History

Complete list of historical versions of study NCT00228605 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assess the patients' quality of life through questionnaires
Assess the patients' overall medication preferences
Assess the patients' overall medication performance

Original Secondary Outcome Measures ^ICMJE

Assess the patients quality of life through questionnaires
Assess the patients overall medication preference
Asses the patients overall medication performance

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Condition ^ICMJE

Low Back Pain
Migraine
Diabetic Neuropathies
Osteoarthritis

Intervention ^ICMJE

Drug: OraVescent Fentanyl

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

500

Completion Date

May 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00228605

Responsible Party

Study ID Numbers ^ICMJE

C25608/3040/BP/US

Study Sponsor ^ICMJE

Cephalon

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Gwendolyn Neibler, DO

Cephalon

Information Provided By

Cephalon

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP