Overview

A Study of Safety and Effectiveness of Ultracet in Patients With Chronic Cancer Pain

Status:
Completed
Trial end date:
2007-04-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the analgesic (painkiller) effectiveness and safety of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) in the treatment of chronic cancer pain.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen-Cilag Ltd.,Thailand
Treatments:
Acetaminophen
Tramadol
Criteria
Inclusion Criteria:

- Participants whose pain has reached a stage now requiring treatment with a weak
opioid, according to the opinion of treating physician

- Participants who have received a regular weak opioid, for at least 48 hours and at a
dosage appropriate for their pain at that time

- Participants with a histologically, radiologically or hematologically confirmed
malignancy; whose pain is judged by the investigator to be caused by the malignancy

Exclusion Criteria:

- Participants who have already received regular treatment with a strong opioid for
their cancer pain. This should not exceed more than 3 doses of a strong immediate
release opiod in last 7 days, and none in last 24 hours

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

- Participants with a history of allergy or hypersensitivity to tramadol or
acetaminophen

- Participants who, at entry have treatments planned which may alter abruptly, the
degree or nature of pain experienced (eg radiotherapy, neurological techniques
surgery)

- Participants with a history of abuse of opioid analgesics prior to their diagnosis of
cancer