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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 4

Conditions

Cancer

Treatments

Drug: Tramadol HCI/acetaminophen

Study type

Interventional

Funder types

Industry

Identifiers

NCT01968018

TRAMAPANA4001 (Other Identifier)

CR013510

Details and patient eligibility

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.

Full description

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 acetaminophen will not exceed 4,000 mg. The total duration of the study treatment for each participant will be approximately 6 weeks. Safety will be evaluated by assessment of adverse events, clinical laboratory tests, skin site assessments, vital signs, and physical examination which will be monitored throughout the study.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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