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ORAVESCENT Fentanyl

Phase 3

Chronic Low Back Pain | Small molecule | Pain |Teva Pharmaceutical Industries Limited|Last Updated: May 9, 2014

Success Probability

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Trial Design

RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

ORAVESCENT Fentanyl · 6 trials · 8 indications

Phase 3 6
NCT00343733Study 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 PainPain
COMPLETED120 Analytics
NCT00214942Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for Management of Breakthrough PainChronic Low Back Pain
COMPLETED- Analytics
NCT00214955Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough PainChronic Neuropathic Pain
COMPLETED120 Analytics
NCT00228605Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough PainLow Back Pain
COMPLETED500 Analytics
NCT00105287Treatment of Breakthrough Pain in Opioid Tolerant Cancer PatientsPain
COMPLETED100 Analytics
NCT00105937OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer PatientsPain
COMPLETED300 Analytics
PHASE3COMPLETED
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
PainUnlock trial analytics
PHASE3COMPLETED
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain
Chronic Low Back PainUnlock trial analytics
PHASE3COMPLETED
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain
Chronic Neuropathic PainUnlock trial analytics
PHASE3COMPLETED
Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain
Low Back PainUnlock trial analytics
PHASE3COMPLETED
Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
PainUnlock trial analytics
PHASE3COMPLETED
OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
PainUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary objective is to evaluate the efficacy of OraVescent fentanyl treatment compared with placebo treatment following 12 weeks of treatment in alleviating breakthrough pain (BTP) in opioid-tolerant patients with noncancer-related chronic pain.
Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients
Tolerability and safety of OraVescent fentanyl when used long-term

Secondary Endpoints

Assess the patients' quality of life through questionnaires
Assess the patients' overall medication preferences
Assess the patients' overall medication performance
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
PurposeTREATMENT

Interventions

NameTypeDescription
OraVescent FentanylDRUG -
ORAVESCENT Fentanyl CitrateDRUG -
OraVescent fentanyl (OVF)DRUG -
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: Patients are included in the study if all of the following criteria are met: * The patient is willing to provide written informed consent to participate in this study. * The patient is 18 through 80 years of age. * Women must be surgically sterile, 2 years postmenopausal, or, i...

Countries:United States
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Frequently asked questions about ORAVESCENT Fentanyl

What is ORAVESCENT Fentanyl used for?

ORAVESCENT Fentanyl is an investigational small molecule being developed for the management of breakthrough pain in opioid-tolerant patients. It has been studied in conditions including chronic low back pain, chronic neuropathic pain, and cancer-related pain. The drug is in Phase 3 clinical development.

What does ORAVESCENT Fentanyl target?

ORAVESCENT Fentanyl is a small molecule that targets opioid receptors. It is designed to provide rapid pain relief for breakthrough pain episodes. The drug is being studied in opioid-tolerant patients with chronic pain conditions.

Who makes ORAVESCENT Fentanyl?

ORAVESCENT Fentanyl is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 3 clinical trials to evaluate the drug's efficacy and safety for breakthrough pain management.

What phase is ORAVESCENT Fentanyl in?

ORAVESCENT Fentanyl is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The completed Phase 3 trials studied its use in breakthrough pain associated with cancer, chronic low back pain, and chronic neuropathic pain.

What clinical trials is ORAVESCENT Fentanyl in?

ORAVESCENT Fentanyl has completed three Phase 3 trials: NCT00105937 in cancer pain, NCT00214942 in chronic low back pain, and NCT00214955 in chronic neuropathic pain. A fourth trial, NCT00343733, studied noncancer-related chronic pain. All trials were conducted in the United States.

Is ORAVESCENT Fentanyl the same as fentanyl citrate?

ORAVESCENT Fentanyl is a formulation of fentanyl citrate, as indicated by the trial titles for NCT00214942, NCT00214955, and NCT00343733. It is an investigational product being developed for breakthrough pain management in opioid-tolerant patients.