Efficacy and Safety of Polyethylene Glycol 3350 (PEG 3350) for Relief of Constipation (MK-8114-005)

This is an interventional treatment trial for Constipation Read More

Inclusion Criteria:

• meets diagnostic criteria for functional constipation. This includes loose stools that are rarely present without the use of laxatives and 2 or more of the following: straining during at least 25% of defecations; lumpy or hard stools in at least 25% of defecations; sensation of incomplete evacuation for at least 25% of defecations; sensation of anorectal obstruction/blockage for at least 25% of defecations; manual maneuvers to facilitate at least 25% of defecations [e.g., digital evacuation, support of the pelvic floor]; and fewer than 3 defecations per week. Criteria for functional constipation must be fulfilled for last 3 months, with symptom onset at least 6 months prior to diagnosis.
• willing to use study drug for up to 7 days as directed, and must agree to record bowel movements (frequency, consistency, etc.) accurately and consistently in a daily diary, and make 3 clinic visits.
• except for constipation, must be otherwise in good health, as determined by physical exam and medical history.
• agrees not to use any other products (drug, herbal, dietary supplements including fiber, etc.) to treat their constipation during the course of the study.
• agrees not to use any medication known to cause constipation during the course of the study.
• agree to maintain a similar diet from the week prior to randomization through the end of the study.
• females must be either surgically sterile, 2 years post-menopausal, or attest that they are using an acceptable method of contraception (including hormonal birth control, intrauterine device [IUD], double barrier methods, or vasectomized partner).
• females of childbearing potential must have urine pregnancy test (human chorionic gonadotropin [HCG]) that is negative at Baseline.
• must be able to read the diaries in Russian.

Exclusion Criteria: - currently under a doctor's care and treatment for constipation.

• have current constipation episode for more than one week prior to randomization.
• history of chronic constipation due to any underlying cause (inflammatory bowel disease, etc.).
• history of more than 3 months of constipation in the past year.
• have severe abdominal pain as the predominant constipation symptom.
• had with bowel movement in 48 hours prior to randomization.
• have celiac disease or known gluten sensitivity.
• history of colorectal cancer, anal abscess, anal fistula, anal fissure, anal stenosis, gastric retention or obstruction, bowel resection, rectocele, or colostomy.
• have known renal or hepatic insufficiency.
• have gastrointestinal bleeding or acute infection.
• history of alcohol or drug abuse.
• history of psychiatric disorders.
• history of significant ongoing medical problems, including kidney disease, or are scheduled for surgical procedures.
• currently taking or have taken within 7 days of randomization a concomitant medication that causes constipation, including opiates, antidepressants, selective serotonin reuptake inhibitors (SSRIs), antimotility agents, and anticholinergics, etc.
• plan to use laxatives during the treatment period other than the study medication.
• have participated in an investigational clinical, surgical, drug or device study within the past 30 days. (Concurrent skin patch testing of cosmetic or suncare products is allowed.)
• pregnant or lactating.
• allergic to polyethylene glycol or maltodextrin.
• employed or have immediate family members employed by a company that manufactures laxative products.