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临床试验/NCT00458289
NCT00458289已完成1 期

Efficacy of Phosphate Binding in Healthy Volunteers: Chewed Versus Crushed Lanthanum Carbonate

University of Illinois at Chicago1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
12
试验地点
1
主要终点
Serum phosphorous concentration

研究概览

简要总结

Patients with end-stage renal disease (ESRD) commonly have high concentrations of phosphorous, a mineral, in the blood (hyperphosphatemia). This is a result of their inability to excrete phosphorous by the kidneys. This in turn may result in the development of a condition known as secondary hyperparathyroidism and renal osteodystrophy or bone disease. As such, these patients often receive medications known as phosphate binders such as calcium carbonate or acetate, sevelamer, aluminum hydroxide and lanthanum carbonate to manage and treat hyperphosphatemia.

Lanthanum carbonate is a newly available phosphate binding agent that is effective in the management of hyperphosphatemia and preventing secondary hyperparathyroidism. It works in the gastrointestinal tract by binding to the phosphorus in the diet. ESRD patients taking lanthanum carbonate are counseled to chew the tablets completely before swallowing, with or immediately after meals. However, patients who are intubated or receiving nutrition via feeding tubes are unable to chew the tablets. For these patients, medications are commonly crushed and administered via the tube. Moreover, some patients prefer to crush the tablets and mix it with food instead of chewing. To date, it is not known if crushing the lanthanum carbonate tablets prior to administration and taking it with food would be as effective as chewing them.

The purpose of this study is to compare the efficacy of phosphate binding between chewed and crushed lanthanum carbonate tablets.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

入选标准

  • Men and women at least 18 years of age
  • No clinically significant abnormal findings on clinical laboratory evaluation and medical history
  • Within 15% of ideal body weight for height and build according to the Metropolitan Life tables5
  • Women of child-bearing potential (premenopausal and not surgically sterilized) who have a negative pregnancy test
  • Women who are sexually active must be using effective means of contraception

排除标准

  • History of dysphagia or swallowing disorders
  • Clinically significant illness within 3 months of study enrollment
  • Concomitant use of medication that might interact with lanthanum carbonate
  • Pregnant or intends to become pregnant within 30 days of completing the study
  • Breast feeding
  • Alcohol or controlled substance abuse
  • Use of an investigational agent within 30 days of study entry

研究组 & 干预措施

2

Active Comparator

P-containing meal AND single 1 g oral dose of chewed lanthanum carbonate

干预措施: Lanthanum carbonate (chewed vs. crushed) (Drug)

3

Active Comparator

P-containing meal and single 1 g oral dose of lanthanum carbonate crushed into a fine powder

干预措施: Lanthanum carbonate (chewed vs. crushed) (Drug)

结局指标

主要结局

Serum phosphorous concentration

时间窗: Hourly from time=0-8 h after administration of meal and drug

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alan Lau

Professor

University of Illinois at Chicago

研究点 (1)

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