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 - Full Text View

Sponsor:	Johnson & Johnson Taiwan Ltd
Information provided by:	Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier:	NCT00576173

Purpose

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	Intervention	Phase
Pain	Drug: tramadol hydrochloride; acetaminophen	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Tramadol Tramadol hydrochloride Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Taiwan Ltd:

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.

Enrollment:	60
Study Start Date:	December 2005
Study Completion Date:	February 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576173

Sponsors and Collaborators

Johnson & Johnson Taiwan Ltd

Investigators

Study Director:

Johnson & Johnson Taiwan, Ltd. Clinical Trial

Johnson & Johnson Taiwan Ltd

More Information

No publications provided

Study ID Numbers:	CR014683
Study First Received:	December 14, 2007
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00576173 History of Changes
Health Authority:	Taiwan: Department of Health

Keywords provided by Johnson & Johnson Taiwan Ltd:

Cancer pain
Breakthrough pain
acetaminophen
tramadol hydrochloride
Ultracet

Additional relevant MeSH terms:

Tramadol
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Acetaminophen
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010