Clinical trial NCT01968018: A Study of Safety and Effectiveness of Ultracet in Patients With Chronic Cancer Pain
Official title: A Study of Safety and Efficacy of Ultracet in Patients With Chronic Cancer Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer
Keywords: Cancer
Chronic Cancer Pain
Tramadol HCI
Acetaminophen
Analgesics
Pain assessment
Lead sponsor: Janssen-Cilag Ltd.,Thailand
Sponsor class: INDUSTRY
First posted: 2013-10-23
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Change From Baseline in Brief Pain Inventory (BPI) Pain Severity "Pain at Its Worst" (BPI Item 3) at Day 42
timeFrame: Baseline (Day 1) to Day 42
measure: Change from Baseline in Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score
timeFrame: Baseline (Day 1) to Day 42
measure: Number of Participants With Adverse Events
timeFrame: Up to Day 42
measure: Number of Doses of Rescue Medication Over Time
timeFrame: Days 7, 14, 28, 35 and 42
Secondary outcomes:
measure: Number of Participants With Patient Global Assessment (PGA)
timeFrame: Day 42
measure: Number of Participants With Investigator Global Assessment
timeFrame: Day 42
measure: Change From Baseline in Quality of Life (QOL) by Using Functional Assessment of Cancer Therapy General Scale (FACT-G) Total Score at Day 42
timeFrame: Baseline (Day 1) and Day 42
Other outcomes:
Locations:
city: Bangkok
country: Thailand
Study officials:
affiliation: Janssen-Cilag Ltd.,Thailand
name: Janssen-Cilag Ltd.,Thailand Clinical Trial
role: STUDY_DIRECTOR
References: