NCT00771654撤回不适用
Does the Addition of Phentermine Increase Weight Loss in the Obese After Gastric Band Operation?
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Primary outcomes are total weight loss and excess weight
研究概览
简要总结
This is a prospective, randomized, double-blind controlled trial. The goal is to show whether the administration of daily oral Phentermine will augment patient weight loss and resolve obesity associated comorbidities following gastric band operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult age 18-65
- •BMI 35-55
- •Approved for gastric band operation
排除标准
- •A known allergy to Phentermine
- •Take medications for Attention Deficit Disorder (ADD)
- •Monoamine oxidase inhibitors (MAOI)for depression
- •Selective serotonin reuptake inhibitor (SSRIs)for depression
- •History of heart problems (congested heart failure, coronary artery disease,cardiac stents, cardiac arrhythmias
- •Hyperthyroidism
- •Psychosis
- •History of drug abuse
- •Uncontrolled hypertension (diastolic >85)
研究组 & 干预措施
Placebo
Placebo Comparator
Subjects will be randomized to the daily dosing of either oral Phentermine 37.5mg or placebo to commence at their 2 week follow-up appointment following their gastric band procedure
干预措施: Placebo (Other)
Phentermine
Experimental
Subjects will be randomized to the daily dosing of either oral Phentermine 37.5mg or placebo to commence at their 2 week follow-up appointment following their gastric band procedure
干预措施: Phentermine (Drug)
结局指标
主要结局
Primary outcomes are total weight loss and excess weight
时间窗: one year
次要结局
- Secondary outcomes is resolution of preoperative comorbidities(one year)
研究者
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