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Therapeutic Areas: Oncology
Disease Category: Cancer Pain

Trial Information

This is a Multicenter, Randomized, Placebo-Controlled research study to evaluate the effectiveness of ARX-F02 (Sublingual Sufentanil NanoTab™) versus placebo ("sugar" pill) in the management of breakthrough pain in cancer patients. The drug being evaluated in this study, Sufentanil has already been approved by the FDA for intravenous (IV) anesthetic use during operative procedures. It has not yet been approved for sublingual (under the tongue) use, which is what this study is evaluating.

If you are 18 years or older, diagnosed with cancer, have 1-4 episodes of breakthrough episodes per day, and are taking prescription medication for pain you may qualify to participate in this study evaluating an investigational medication for the treatment of cancer breakthrough pain.

This study consists of three phases:

• Screening — The screening visit is when your doctor will talk to you about participating in this study. You will be instructed as to why you are being asked to participate and what you will need to do to be in the study. The visit includes informed consent, a medical history review, a physical examination, ECG, and routine blood work. If eligible, you will move into the Titration Phase.
• Titration Phase — Once you have met all study entry criteria, you will enter the open-label titration phase during which you will take different dosages of study medication (Sublingual Sufentanil NanoTabs™), increasing in strength as needed, to determine a dose that provides adequate pain relief without intolerable side effects. This titration period may last for up to three weeks, depending upon the frequency of your breakthrough pain episodes and use of the study medication.
• Double-Blind Treatment Phase — Once you determine an effective dose of study medication, you will enter the double-blind phase of the study during which you will take a dose of Sublingual Sufentanil NanoTabs™ (at the dosage you identified as effective during titration) as needed for breakthrough pain episodes. Three of the ten doses will contain placebo (inactive substance). Neither you nor your doctor will know which of the pills contain the active medication and which are placebos. With each dose taken, you will be asked to electronically record your current pain intensity and relief. This phase can last up to 3 weeks depending upon the frequency of your breakthrough pain episodes and use of study medication.

During the study, you will be permitted to use your prescribed rescue medications as needed but must wait at least 30 minutes after taking a dose of study medication. The study doctor’s staff will contact you daily while you are taking study medication to ask how you are doing and see if you have any questions.

Inclusion Criteria:

• Patients 18 years of age or older with documented clinical history or evidence of a malignancy.
• Patients taking opioid medication every day for cancer pain.
• Patients experiencing 1 — 4 episodes of cancer breakthrough pain per day requiring use of an additional opioid pain medication
• Patient has a life expectancy of at least 3 months.
• Patient must be able to provide reliable documentation of pain intensity, pain relief, use of rescue medication, and global evaluation of treatment personally or with the help of a caregiver.
• Patient must be able to enter simple commands on a provided Palm Pilot device, personally or with the help of a caregiver.

Exclusion Criteria:

• Patients with a history of psychiatric disease or loss of cognitive function that would prevent patient from providing reliable study documentation.
• Patients with a history of substance abuse within the past year.
• Patients with significant heart or lung disease, as deemed by the investigator.
• Patients with abnormal lab results that are deemed by the Investigator to be clinically significant. Abnormalities that are cancer related should be documented.
• Patients who will be receiving chemotherapy or radiation treatment during the 3- week titration phase or 3-week double-blind phase that, in the Investigator’s opinion, may dramatically alter the patient’s pain level or response to pain medications.
• Patients who have participated in a clinical trial of an investigational drug or device within 30 day of screening.

Juan Castro
Redpoint Research
11045 N 19th Ave.
Phoenix, AZ 85029
Phone: 602-395-1200
Fax: 602-395-2616
EMail: juan@redpointresearch.com

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