Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain
CompletedPhase 3NCT00214955
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant Patients with Chronic Neuropathic Pain
Study details
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Neuropathic Pain
- Conditions
- Interventions
- Drug: ORAVESCENT Fentanyl Citrate
- Sponsor
- Cephalon
- Organization
- Teva Branded Pharmaceutical Products R&D, Inc.
- Start date
- 2005-09
- Primary completion
- 2006-05
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 17
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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, if of childbearing potential, using a medically accepted method of birth control (ie, barried method with spermicide, steroidal contraceptive \[oral, transdermal, implanted, or injected contraceptives must be used in conjunction with a barrier method\], or intrauterine device \[IUD\]) and agree to continued use of this method for the duration of the study. * The patient has chronic neuropathic pain of at least 3 months duration associated with any of the following conditions: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, or complex regional pain syndrome. Patients with other neuropathic pain etiologies may qualify for the study with permission from the Cephalon medical monitor or designee. * The patient is currently using 1 of the following: at least 60 mg of oral morphine/day, or at least 25 mcg transdermal fentanyl/hour, or atleast 30 mg or oxycodone/day, or at least 8 mg hydromorphone/day, or an equianalgesic dose of another opioid/day as a stable dose of around-the-close (ATC) therapy for at least the previous 7 days before enrollment in the study. * The patient reports an average pain intensity (PI) score, over the prior 24 hours, of less than 7 (0=no pain through 10=worst pain) for their chronic neuropathic pain. * The patient experiences, on average, 1 to 4 BTP episodes (defined as temporary flares of sever or excruciating pain) per day while taking ATC opioid therapy, and on average, the duration of each BTP episode is less than 4 hours. * The patient currently uses opioid therapy for alleviation of BTP episodes, occuring at the location of the chronic pain, and achieves at least partial relief. * The patient is able to effectively self-administer the study drug. Exclusion Criteria: Patients are excluded from participating in this study if 1 or more of the following criteria are met: * The patient has uncontrolled or rapidly escalating pain as determined by the investigator (ie, the ATC therapy may be expected to change between the first and last treatments with study drug), or has pain uncontrolled by therapy that could adversely impact the safety of the patient or that could be compromised by treatment with study drug. * The pa…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00214955