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

Sponsored by Janssen-Cilag Ltd.,Thailand

About this trial

Last updated 13 years ago

Study ID

CR013510

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18+ Years
All Sexes

Trial Timing

Ended 19 years ago

What is this trial about?

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.

What are the participation requirements?

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