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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


Phase 4
18 Years
N/A
Not Enrolling
Both
Pain

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Trial Information

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.


Inclusion Criteria:



- Patients with a histologically, radiologically or haematologically confirmed
malignancy whose pain is judged by the investigator to be caused by the malignancy

- Patients must have been on a stable daily dose of weak opioids or strong opioids for
at least 72 hours prior to the start the study and must remain at the same dosage for
the duration of the study

- Patients must have a VAS (Visual analog scale) >=40mm

Exclusion Criteria:

- Patients who have taken either morphine with daily dose more than 120mg or Fentanyl
with daily dose more than 50ug/hr

- Patients with significant abnormalities in hepatic or renal function which would, in
the opinion of the investigator, prevent the patients involvement in the study

- Patients with significant clinical abnormalities in CNS, respiratory or
cardiovascular function, which in the investigators judgement prevents participation
in the study

- Patients who have taken antidepressants or anti-epileptic drugs, sedative hypnotics,
selective serotonin reuptake inhibitor, short-acting analgesics, topical medications
and anesthetics and/or muscle relaxants when taking Tramadol/Acetaminophen

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Johnson & Johnson Taiwan, Ltd. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Johnson & Johnson Taiwan Ltd

Authority:

Taiwan: Department of Health

Study ID:

CR014683

NCT ID:

NCT00576173

Start Date:

December 2005

Completion Date:

February 2007

Related Keywords:

  • Pain
  • Cancer pain
  • Breakthrough pain
  • acetaminophen
  • tramadol hydrochloride
  • Ultracet

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