The Impact of Generic Labels on Consumption Dosage and Medication Compliance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 主要终点
- Non-Compliance
研究概览
简要总结
Although generic drugs are pharmacologically equivalent to their brand-name counterparts, prejudices against the former remain strong among patients and doctors. In a randomized controlled field experiment, this research assesses the extent to which generic (versus brand-name) labels affect patients' consumption dosage, medication compliance and reported pain.
详细描述
One hundred one patients scheduled to undergo invasive dental surgeries (i.e., dental implants) participated in the experiment. After dental surgery, patients were prescribed a once-daily analgesic regimen for up to 7 days. The intervention consisted of label manipulation. Patients were randomly assigned to either the brand-name analgesic or to its (purportedly) cheaper generic version. In reality, all participants obtained the same brand-name medication. The medication was provided at no cost, and patients were instructed to take the first pill while at the clinic. They were informed that they could (a) increase the dosage of the prescribed analgesic to twice daily if necessary and (b) stop taking the medication when no longer needed. Any other changes to the regimen were discouraged, and patients were instructed to consult with the dentist before any such changes. Telephone follow-ups were conducted at 24 hours, 4 days, and 7 days after surgery. Two main dependent variables were obtained: the number of prescribed analgesics consumed and the number of non-prescribed analgesics consumed. The patients also reported the pain felt during the period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo dental implants and/or bone graft surgeries at the UFSC dental clinic
排除标准
- •Patients not scheduled to undergo these treatments
研究组 & 干预措施
Brand-name Label
actual brand-name analgesic presented
干预措施: Label (Other)
Generic Label
Purportedly generic version of the analgesic presented
干预措施: Label (Other)
结局指标
主要结局
Non-Compliance
时间窗: 4 days after the intervention
Number of patients who consumed at least one non-prescribed analgesic pill during the period (from day 2 to day 4)
Non-compliance
时间窗: 7 days after the intervention
Number of patients who consumed at least one non-prescribed analgesic pill during the period (from day 5 to day 7)
Non-Compliance
时间窗: 1 day after the intervention
Number of patients who consumed at least one non-prescribed analgesic pill during the first 24 hours
次要结局
- Consumption Dosage(4 days after the intervention)
- Consumption dosage(7 days after the intervention)
- Consumption Dosage(1 day after the intervention)
研究者
Marco Aurelio Bianchini
Associate Professor of Dentistry
Universidade Federal de Santa Catarina