Trial Condition(s):

Constipation

Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)

Bayer Identifier:

18129

ClinicalTrials.gov Identifier:

NCT01212445

EudraCT Number:

2010-021367-32

Study Completed

Trial Purpose

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.

Inclusion Criteria
- 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 Criteria
- 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

Trial Summary

Enrollment Goal
154
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Transipeg (Macrogol, BAY81-8430)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Suite 2.6 Consultants Private Clinic

ork, Ireland

Status
Completed
 

Trial Design