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

Sponsor

Johnson & Johnson Taiwan Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT00576173

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the analgesic effectiveness and safety of 37.5mg Tramadol hydrochloride/325mg Acetaminophen in the treatment of breakthrough pain in cancer patients.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: tramadol hydrochloride; acetaminophen	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2005

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

Primary Outcome Measures

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. []

Secondary Outcome Measures

Investigator global assessment and patient global assessment for the treatment with respect to pain control, side effects and overall using a 5-point scale at the end of the treatment phase. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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