Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Multi-center Study Evaluating 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

NCT00105287

Enrollment

100

Registered

2005-03-14

Start date

2005-01-31

Completion date

2007-09-30

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

Cancer, Pain

Keywords

cancer, pain, Breakthrough Pain in cancer patients

Brief summary

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

Interventions

DRUGOraVescent fentanyl (OVF)

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

* Documented diagnosis of a malignant solid tumor or hematological malignancy causing cancer related pain * Currently taking around the clock opioid therapy for pain * Experience on average, 1-4 breakthrough pain episodes per day

Exclusion criteria

* Opioid or fentanyl intolerance * Sleep apnea or active brain metastases with increased intracranial pressure * COPD (chronic obstructive pulmonary disease); cardiopulmonary disease; heart disease

Countries

United States

Outcome results

None listed

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