Clinical trial NCT00343733 (phase 3, status: completed)
Conditions: pain
ICD codes: N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52
Drugs: oravescent fentanyl
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@]12C
Eligibility criteria:

        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, barrier method with
             spermicide, steroidal contraceptive [oral, transdermal, implanted, and 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 pain of at least 3 months' duration associated with any of the
             following conditions: diabetic peripheral neuropathy, postherpetic neuralgia,
             traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia
             (documented diagnosis), chronic pancreatitis, or osteoarthritis. Other chronic painful
             conditions may be evaluated for entry upon discussion with, and written approval from,
             the Cephalon Medical Monitor.

          -  The patient is currently using 1 of the following: at least 60 mg of oral
             morphine/day, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of
             oxycodone/day, or at least 8 mg of hydromorphone/day, or an equianalgesic dose of
             another opioid/day as a stable dose of ATC therapy for at least the previous 30 days
             prior to enrollment in the study.

          -  The patient reports an average pain intensity score, over the prior 24 hours, of 6 or
             less (0=no pain through 10=worst pain) for his/her chronic pain.

          -  The patient experiences, on average, 1 to 4 BTP episodes (defined as temporary flares
             of severe 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, occurring
             at the location of the chronic pain, and achieves at least partial relief.

          -  The patient is able to effectively self-administer the study drug and complete the
             electronic diary.

        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 patient has known or suspected hypersensitivities, allergies, or other
             contraindications to any ingredient in the study drug.

          -  The patient has a recent history (within 5 years) or current evidence of alcohol or
             other substance abuse.

          -  The patient has cardiopulmonary disease that would, in the opinion of the
             investigator, significantly increase the risk of treatment with potent synthetic
             opioids.

          -  The patient has medical or psychiatric disease that, in the opinion of the
             investigator, would compromise collected data.

          -  The patient is expected to have surgery during the study and it is anticipated that
             the surgery will alleviate the patient's pain.

          -  The patient has had therapy before study drug treatment that, in the opinion of the
             investigator, could alter pain or response to pain medication.

          -  The patient is pregnant or lactating.

          -  The patient has participated in a previous study with OraVescent fentanyl.

          -  The patient has participated in a study involving an investigational drug in the
             previous 30 days.

          -  The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before
             the first treatment with study drug.

          -  The patient has any other medical condition or is receiving concomitant
             medication/therapy (eg, regional nerve block) that would, in the opinion of the
             investigator, compromise the patient's safety or compliance with the study protocol,
             or compromise collected data.

          -  The patient is involved in active litigation in regard to the chronic pain currently
             being treated.

          -  The patient has a positive urine drug screen (UDS) for a medication not prescribed by
             the physician currently treating the chronic pain.