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Sponsored by: |
Johnson & Johnson Taiwan Ltd |
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Information provided by: | Johnson & Johnson Taiwan Ltd |
ClinicalTrials.gov Identifier: | NCT00576173 |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | December 2005 |
Study Completion Date: | February 2007 |
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 Fantanyl >=25 ug/hr, the breakthrough pain medication will be 2 tablets.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR014683 |
Study First Received: | December 14, 2007 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00576173 |
Health Authority: | Taiwan: Department of Health |
Cancer pain Ultracet acetaminophen tramadol hydrochloride Breakthrough pain |
Tramadol Pain Acetaminophen |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid Pharmacologic Actions |