A Randomized, Open-Label, Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 154
- 主要终点
- Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration
研究概览
简要总结
The primary objective of the study was to evaluate the proportion of subjects with a bowel movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). The doses specified relate to the doses of PEG. Secondary objectives were measured by analysis of a subject diary and self-reported BM data. The secondary objectives included comparisons of PEG+E doses at 24 h for: BM control; relief of gas; relief of bloating; and relief of abdominal discomfort/cramping.
In addition, the proportion of subjects with a BM (without straining and without hard and/or lumpy stool) within the first 24 h of treatment for subjects taking different doses of PEG+E was evaluated for the time to first BM.
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
- 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
- 否
入选标准
- •A willingness to participate in the study and comply with its procedures
- •Must be ambulatory
- •Male or female subjects aged 18 years or older who met two or more of the following modified Rome III-based criteria for constipation: (a) straining during at least 25% of defecations; (b) lumpy or hard stools in at least 25% of defecations; (c) sensation of incomplete evacuation for at least 25% of defecation; (d) sensation of anorectal obstruction/blockage for at least 25% of defecations; (e) manual maneuvers to facilitate at least 25% of defecations (eg, digital evacuation, support of the pelvic floor), and (f) fewer than 3 defecations per week
- •Criteria fulfilled for the last 3 months with symptom onset at least 6 mo prior to diagnosis
- •Had a self reported or documented history of chronic constipation
- •Agreed not to use laxatives other than the study treatment from baseline/informed consent to end-of-study
- •Agreed to maintain a similar diet from the week before Visit 3 to the end-of-study were to be enrolled
- •Additionally required not to use any treatment known to cause constipation during the study (for subjects enrolled after Amendment 1)
- •If a female subject, either surgically sterile, 2 years postmenopausal, or using an acceptable method of contraception. Abstinence was not an acceptable method of contraception. Females of childbearing potential had to have a urine pregnancy test (human chorionic gonadotropin [HCG]) that was negative at Visit 3
- •Be able to read and write in the diaries in English
排除标准
- •Had loose stools without the use of laxatives
- •Recurrent abdominal pain
- •Known or suspected bowel perforation, obstruction, or fecal impaction; or had gastric retention, inflammatory bowel disease, bowel resection, or colostomy
- •Celiac disease or known gluten sensitivity
- •Known renal or hepatic insufficiency
- •Recent history of alcohol abuse or drug abuse
- •History of psychiatric disorders
- •History of significant ongoing medical problems or scheduled for surgical procedures
- •Subjects who, in the opinion of the Investigator, should not have been included in the study for any reason, including inability to follow study procedures
- •Participated in an investigational clinical, surgical, drug or device study within the past 30 days
- •Pregnant or lactating
- •Allergic to PEG or PEG+E
- •Employed by or have immediate family members employed by a company that manufactures laxative products
- •Participant or family member of the Investigator or site staff directly involved with this study
研究组 & 干预措施
PEG + E, 13.125 g
Single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time
干预措施: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430) (Drug)
PEG + E, 26.25 g
Two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time
干预措施: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430) (Drug)
PEG + E, 39.375 g
Three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time
干预措施: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430) (Drug)
结局指标
主要结局
Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration
时间窗: From time of study drug treatment up to 24 hours
A successful BM was defined as a BM with no straining or hard/lumpy stools.
次要结局
- Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration(From time of study drug treatment up to 12 hours)
- Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration(From time of study drug administration up to 3 Days)
- Mean Visual Analog Scale (VAS) Rating for BM Control(From time of study drug treatment up to 24 hours)
- Mean VAS Rating for Gas(From time of study drug treatment up to 24 hours)
- Mean VAS Rating for Abdominal Discomfort/Cramping(From time of study drug treatment up to 24 hours)
- Mean Participant Global Assessment of Treatment(From time of study drug administration up to 2 Days)
- Mean VAS Rating for Bloating(From time of study drug treatment up to 24 hours)