Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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 design
Primary purpose
Allocation
Interventional model
Masking
154 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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