A Study of Safety and Efficacy of Ultracet in Patients With Chronic Cancer Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 主要终点
- Number of Doses of Rescue Medication Over Time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tramadol HCI + acetaminophen
干预措施: Tramadol HCI/acetaminophen (Drug)
结局指标
主要结局
Number of Doses of Rescue Medication Over Time
时间窗: Days 7, 14, 28, 35 and 42
Number of doses of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study medication is not satisfactory, or the effect of the study medication is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (medication used to control pain) were used as rescue medication.
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity "Pain at Its Worst" (BPI Item 3) at Day 42
时间窗: Baseline (Day 1) to Day 42
Change from baseline in pain severity was assessed using the Brief Pain Inventory (BPI) questionnaire, specifically "pain at its worst" (BPI item 3) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its worst".
Change from Baseline in Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score
时间窗: Baseline (Day 1) to Day 42
The analgesic effect was assessed by the Brief Pain Inventory (BPI) item 5 "pain on average" using a 0 to 10 numeric rating scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine". Higher scores indicate worsening.
Number of Participants With Adverse Events
时间窗: Up to Day 42
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
次要结局
- Number of Participants With Patient Global Assessment (PGA)(Day 42)
- Number of Participants With Investigator Global Assessment(Day 42)
- Change From Baseline in Quality of Life (QOL) by Using Functional Assessment of Cancer Therapy General Scale (FACT-G) Total Score at Day 42(Baseline (Day 1) and Day 42)