A Randomized, Single-Blind, Single Research Site, Comparison of Colesevelam Hydrogen Chloride (HCl) Powder For Oral Suspension Versus Generic Cholestyramine Through Use of the Bile Acid Sequestrant Acceptability (BASA) Scale in Generally Healthy Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Patient Acceptability of Colesevelam HCl Powder for Oral Suspension vs. Generic Cholestyramine Via the Bile Acid Sequestrant Acceptability (BASA) Scale, Based Upon an Anticipated Equivalent Cholesterol Lowering Doses of Each Comparator Drug.
研究概览
简要总结
The objective of this study is to compare the acceptability of Colesevelam HCl powder for oral suspension versus generic cholestyramine via the BASA scale, based upon an anticipated equivalent cholesterol lowering doses of each comparator drug.
详细描述
In 2009, colesevelam HCl was approved as a powder formulation. Little objective evidence exists comparing the acceptability of colesevelam HCl powder for oral suspension formulation versus other bile acid sequestrant powder formulations. A Bile Acid Sequestrant Acceptability (BASA) Scale was developed and validated as an instrument to compare the acceptability of different bile acid sequestrant preparations
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women 18-70 years of age
- •In general good health (defined as study participants who are medically stable, meet protocol criteria, but who may also have non-exclusionary ongoing medical conditions).
- •Subjects are capable of giving informed consent, or if appropriate, have an acceptable surrogate capable of giving consent on the subject's behalf.
- •Subjects are willing and readily able to be contacted for post-study safety phone call assessments one to seven days after the single study visit.
排除标准
- •Prior intolerance to bile acid sequestrants
- •Known Phenylketonuria. Colesevelam (Welchol) for Oral Suspension contains 48 mg phenylalanine per 3.75 gram dose.
- •Women who are either pregnant, or who are not practicing any form of birth control.
- •Prior gastrointestinal surgery
- •History of ongoing gastrointestinal symptoms (indigestion, constipation, or diarrhea)
- •History of bowel obstruction, malabsorption, or irritable bowel syndrome
- •History of esophageal disease
- •Current or past history of gallbladder disease
- •History of pancreatitis
- •Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to visit
- •Diagnosis of diabetes mellitus
- •Known history of triglyceride levels > 300 mg/dl.
- •History of alcohol or drug abuse within 1 year of study entry
- •Alcohol intake that exceeds more than 2 units of alcohol drinks per day
- •Exposure to bile acid sequestrants (colesevelam HCl, cholestyramine, colestipol within 30 days of visit 1).
- •Any other situation in which the Investigator makes the judgment that participation in the study would not be in the best interest of the study participant, or in the best interest of providing reliable study data.
研究组 & 干预措施
Cholestyramine 12 grams
Cholestyramine 12 grams
干预措施: Cholestyramine (Drug)
Colesevelam HCl
Colesevelam HCl, 4 grams
干预措施: Colesevelam HCl (Drug)
结局指标
主要结局
Patient Acceptability of Colesevelam HCl Powder for Oral Suspension vs. Generic Cholestyramine Via the Bile Acid Sequestrant Acceptability (BASA) Scale, Based Upon an Anticipated Equivalent Cholesterol Lowering Doses of Each Comparator Drug.
时间窗: 1 Day
The bile acid sequestrant acceptability (BASA) scale has 4 scoring categories: taste, texture, appearance, and mixability. Participants rank each category separately. The best possible score for each category is 5, and the worst possible score for each category is 1.
次要结局
未报告次要终点