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