Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01968018
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01968018
Study Brief:
Protocol Section:
NCT01968018