NCT03017235已完成3 期
A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution Versus Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Powder for Oral Solution (PREPOPIK®) for Colon Cleansing in Preparation for Colonoscopy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 917
- 试验地点
- 14
- 主要终点
- Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good"
研究概览
简要总结
The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •Male or non-pregnant female subjects aged 18 to 80 years, inclusive, being scheduled to undergo elective colonoscopy
- •Females of childbearing potential must agree to use an adequate contraception during the course of the trial. Accepted forms of contraception are: i.e., implants, injectables, hormonal intrauterine device, combined hormonal contraceptives, sexual abstinence, and vasectomized sexual partner. Premenopausal women who are of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at randomization prior to colonoscopy. In the case of oral contraceptive use, women should have been taking the same pill consistently for a minimum of twelve (12) weeks before taking study medication. Sterilized or postmenopausal women may also participate. Women are considered to be postmenopausal and are not considered to be of childbearing potential if they have had twelve (12) months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation.
- •An average of at least 3 spontaneous bowel movements per week for one month prior to the colonoscopy
排除标准
- •Known or suspected gastrointestinal obstruction, perforation, ileus, or gastric retention
- •Acute intestinal or gastric ulceration
- •Severe acute inflammatory bowel disease (IBD), toxic colitis, or toxic megacolon
- •Undergoing colonoscopy for foreign body removal or decompression
- •Reduced level of consciousness or inability to swallow without aspiration
- •Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior endoscopic procedures
- •Upper gastrointestinal surgery (gastrectomy, gastric banding, gastric by-pass)
- •Uncontrolled angina and/or myocardial infarction (MI) within last three months, congestive heart failure (CHF), uncontrolled hypertension, or ascites
- •Severely reduced renal function (<30 mL/min/1.73 m2)
- •Pregnant or lactating women
- •Any clinically relevant abnormal findings in medical history, physical examination, vital signs, ECG, clinical chemistry, hematology, coagulation, or urinalysis at Screening Visit 1
- •Rhabdomyolysis
- •Chronic nausea and vomiting
- •Hypermagnesemia
- •Undergoing treatment with Lithium
研究组 & 干预措施
NaP/MC Oral Solution
Experimental
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
干预措施: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution (Drug)
PREPOPIK®
Active Comparator
干预措施: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder (Drug)
结局指标
主要结局
Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good"
时间窗: During colonoscopy procedure (5-9 hours after completed treatment)
The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.
次要结局
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)(During colonoscopy procedure (5-9 hours after completed treatment))
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)(During colonoscopy procedure (5-9 hours after completed treatment))
- Percentage of Treatment-emergent Adverse Events(AEs)(From baseline (screening) up to day 28 after colonoscopy)
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)(During colonoscopy procedure (5-9 hours after completed treatment))
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)(During colonoscopy procedure (5-9 hours after completed treatment))
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)(During colonoscopy procedure (5-9 hours after completed treatment))
- Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon(During colonoscopy procedure (5-9 hours after completed treatment))
- Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon(During colonoscopy procedure (5-9 hours after completed treatment))
- Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon(During colonoscopy procedure (5-9 hours after completed treatment))
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)(During colonoscopy procedure (5-9 hours after completed treatment))
- Clinically Significant Changes in Vital Signs(From baseline (screening) up to day 28 after colonoscopy)
- Clinically Significant Changes in Laboratory Values(At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy)
- Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)(During colonoscopy procedure (5-9 hours after completed treatment))
- Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)(During colonoscopy procedure (5-9 hours after completed treatment))
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)(During colonoscopy procedure (5-9 hours after completed treatment))
- Clinically Significant Changes in Electrocardiogram (ECG)(At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy)
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)(During colonoscopy procedure (5-9 hours after completed treatment))
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)(During colonoscopy procedure (5-9 hours after completed treatment))
- Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)(During colonoscopy procedure (5-9 hours after completed treatment))
- Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)(During colonoscopy procedure (5-9 hours after completed treatment))
- Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)(During colonoscopy procedure (5-9 hours after completed treatment))
- Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)(During colonoscopy procedure (5-9 hours after completed treatment))
研究者
研究点 (14)
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