Status:
COMPLETED
Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)
Lead Sponsor:
Bayer
Conditions:
Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 sub...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT01212445
Start Date
October 1 2010
End Date
November 1 2011
Last Update
March 15 2016
Active Locations (1)
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1
Cork, Ireland