OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00105937

Enrollment

300

Registered

2005-03-21

Start date

2004-04-30

Completion date

2006-11-30

Last updated

2012-06-29

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

Conditions

Cancer, Pain

Keywords

Cancer, Pain

Brief summary

The purpose of this study is to evaluate the long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant.

Detailed description

The objective of this study is to determine the tolerability and safety of OraVescent fentanyl when used long term to relieve breakthrough pain in opioid tolerant cancer patients.

Interventions

DRUGOraVescent fentanyl citrate

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

* 18-80 years of age * Average of 1-4 breakthrough pain episodes per day * Opioid tolerant * Histologically documented diagnosis of a malignant solid tumor or hematological malignancy

Exclusion criteria

* Primary breakthrough pain is not related to cancer in any way * Opioid or fentanyl intolerance * Chronic obstructive pulmonary disease (COPD) or heart disease * Sleep apnea or active brain metastases with increased cranial pressure

Design outcomes

Primary

Measure	Time frame
Tolerability and safety of OraVescent fentanyl when used long-term	—

Secondary

Measure	Time frame
Assess the effectiveness of OraVescent fentanyl	—
Assess the development of incremental tolerance	—

Countries

United States

Outcome results

None listed

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