A Study of Safety and Effectiveness of Ultracet in Patients With Chronic Cancer Pain
Launched by JANSSEN-CILAG LTD.,THAILAND · Oct 18, 2013
Trial Information
Current as of August 22, 2025
Completed
Keywords
ClinConnect Summary
This is an open-label (all people know the identity of the intervention) study. A total of 35 participants will be enrolled in this study. Participants will receive tablet of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) on Day 1. Participants may increase their daily dosage of study medication as 1 to 2 tablets every 4 to 6 hours as needed for pain relief, up to maximum of 8 tablets per day. Rescue medication consisting of Extra Strength Tylenol (500 mg) 2 tablets daily for the first six days of the Open-label Phase will be allowed so that the total daily dose of acetaminoph...
Gender
ALL
Eligibility 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
About Janssen Cilag Ltd.,Thailand
Janssen-Cilag Ltd., Thailand, is a leading biopharmaceutical company dedicated to advancing healthcare through innovative research and development in pharmaceuticals. As a subsidiary of Johnson & Johnson, Janssen-Cilag focuses on delivering cutting-edge therapies for a wide range of medical conditions, including oncology, immunology, neuroscience, and infectious diseases. Committed to improving patient outcomes and enhancing quality of life, the company actively engages in clinical trials and collaborates with healthcare professionals to address unmet medical needs in the Thai healthcare landscape. With a strong emphasis on ethical practices and regulatory compliance, Janssen-Cilag strives to contribute to the global advancement of medicine while fostering a healthier tomorrow for communities in Thailand.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bangkok, , Thailand
Patients applied
Trial Officials
Janssen-Cilag Ltd.,Thailand Clinical Trial
Study Director
Janssen-Cilag Ltd.,Thailand
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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