An Open Label Study to Evaluate Safety, Tolerability and Clinical Utility of ULTRACET® (37.5mg Tramadol Hydrochloride/325mg Acetaminophen) for the Treatment of Breakthrough Pain in Cancer Patients
The combination of tramadol HCI/acetaminophen provides a more rapid onset of action compared
to tramadol HCI alone and a longer duration of action than acetaminophen alone. Therefore,
the combination of tramadol and acetaminophen may be effective for the treatment of cancer
pain as well as to allow lower cumulative daily dosages of each medication to be used.This
is an open-label study. Patients will receive one-dose treatment of 37.5mg Tramadol/325mg
Acetaminophen tablets.This study has been designed to investigate the following
hypothesis:Tramadol hydrochloride/acetaminophen is effective in the treatment of
breakthrough pain in cancer patients.The patients will complete basic questions on side
effect at visits on entry, 10, 30 mins, and 1h.
The patients will receive only one dose treatment of Tramadol hydrochloride/Acetaminophen
oral tablets throughout the study. The number of oral tablets be given will be depend on the
total daily dose of around-clock medications. If around-clock medication is Tramadol <=400mg
or codeine <=300mg or morphine <60mg, the breakthrough pain medication will be 1 tablet. If
around-clock medication is morphine 60-120mg or Fentanyl >=25 ug/hr, the breakthrough pain
medication will be 2 tablets.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pain intensity and side effect will be assessed on entry, 10, 30 mins, and 1hour. In addition, the amount of rescue analgesic medication consumed will be recorded by the patient and summarized by the investigator at study visits.
Johnson & Johnson Taiwan, Ltd. Clinical Trial
Johnson & Johnson Taiwan Ltd
Taiwan: Department of Health