dose-finding trial of polyethylene glycol 3350 laxative plus electrolytes for the treatment of constipation (protocol p07515)

Conditions: Constipation

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 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.


Eligibility criteria:
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