Symptoms and General Pathology

All Conditions

Nervous System Diseases

Pain

Breakthrough Pain

Neurologic Manifestations

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Anticoagulants

Other Dietary Supplements

Fentanyl

Analgesics, Opioid

Citric Acid

Sodium Citrate

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Citrate

OraVescent fentanyl (OVF)

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.

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

Cephalon

Rare Diseases

Chronic Graft Versus Host Disease

buccal soluble film; 200, 400, 600, 800, 1200 mcg fentanyl; up to 4 times daily

BEMA Fentanyl

David Blum, MD

The purpose of this study is to evaluate the safety of BEMA fentanyl at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used, but because of slow and variable oral absorption, the pain control is not the best with these products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick and is administered by continuously swabbing the interior of the subject's mouth until the product is dissolved (approximately 15 to 30 minutes). The buccal route of administration avoids the delay and variability associated with oral absorption.

BioDelivery Sciences International, Inc. (BDSI) has developed BEMA (BioErodible MucoAdhesive) fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small disc that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the disc readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the disc are water soluble, so the entire dosage form dissolves within 30 minutes of application.

Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy

An Open Label, Long-term Treatment Evaluation of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy

After the first dose of BEMA Fentanyl, all adverse events were recorded and summarized.

BioDelivery Sciences International

From the start of study drug administration to the final follow-up visit.

Open Label Fentanyl Treatment

Age, Categorical

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Andrew Finn, Pharm.D.

All subjects that received at least 1 dose of study drug were included in the analysis.

Percentage of Participants With Adverse Events.

Overall Study

Treatment for breakthrough pain with Fentanyl Citrate Nasal Spray (FCNS)

Fentanyl Citrate Nasal Spray (FCNS)

Goetz Kloecker, MD, FACP, MBA, MSPH

Lazanda is a prescription nasal spray medicine that contains the medicine fentanyl. It is used to manage breakthrough pain in adults with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Lazanda is started only after taking other opioid pain medicines and the patient's body has become used to them (opioid tolerant).

The purpose of this study is to assess the ability of Lazanda to control pain during an episode of breakthrough pain in cancer patients.

An Assessment of the Ability of Fentanyl Citrate Nasal Spray to Manage Breakthrough Pain in Cancer Patients.

An Assessment of the Ability of Fentanyl Citrate Nasal Spray to Manage Breakthrough Pain in Cancer Patients Without a Timely Response to Their Short-acting Opioids.

The primary efficacy outcome measure is pain intensity difference at 15 minutes (PID15) after dosing during the Maintenance Stage. (PID15 is defined as the difference between pain intensity at 15 minutes and baseline.)Maintenance stage is defined as 6 breakthrough pain episodes for up to 6 weeks.

The key secondary outcome measure is the proportion of episodes that the patient defines as satisfactorily managed at 15 minutes.

Satisfaction will be considered to have been achieved for an individual episode of BTPc(Breakthrough pain)if the patient rates pain management as "Satisfied" or "Very Satisfied." Patients complete a satisfaction questionnaire at end of study.

James Graham Brown Cancer Center

University of Louisville

Associate Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients	NCT00105287	Pain Cancer	OraVescent fent...	18 Years - 80 Years	Teva Branded Pharmaceutical Products R&D, Inc.
Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy	NCT00293020	Pain Cancer	BEMA Fentanyl	18 Years -	BioDelivery Sciences International
An Assessment of the Ability of Fentanyl Citrate Nasal Spray to Manage Breakthrough Pain in Cancer Patients.	NCT01839552	Pain	Fentanyl Citrat...	18 Years -	University of Louisville
Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients	NCT00105287	Pain Cancer	OraVescent fent...	18 Years - 80 Years	Teva Branded Pharmaceutical Products R&D, Inc.

Spots Global Cancer Trial Database for breakthrough pain in cancer patients