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

CompletedPhase 4NCT01968018
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
A Study of Safety and Efficacy of Ultracet in Patients With Chronic Cancer Pain
Conditions
Interventions
  • Drug: Tramadol HCI/acetaminophen
Sponsor
Janssen-Cilag Ltd.,Thailand
Start date
2004-07
Primary completion
2007-04
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Thailand
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01968018