Safety and Tolerability of Oral Polyethylene Glycol (PEG 3350) Solution in Participants With Constipation (MK-8114-003)

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the safety and tolerability of oral ingestion of PEG 3350 solution concentrate to oral ingestion of a placebo solution concentrate, in participants with constipation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Bisacodyl; Cathartics; Laxatives; Pharmaceutical Solutions; Polyethylene glycol 3350

Criteria

Inclusion Criteria:

• ambulatory male or female with no history or current evidence of other conditions or abnormalities that would affect study results or interfere with participation for full duration of study

• 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.

• continuous or recurrent symptoms for at least 3 months of: abdominal pain or discomfort, relieved with defecation, or associated with a change in frequency or consistency of stool, and an irregular pattern of defecation at least 25% of the time with 3 or more of the following: altered stool frequency, altered stool form (hard or loose/watery), altered stool passage (straining or urgency, feeling of incomplete evacuation), passage of mucus, and bloating or abdominal distension

• agrees to not use laxatives other than study medication for the duration of the study period

• agrees to not use disallowed concomitant medications for the duration of the study

• agrees to maintain a similar diet and level of activity from the period of the Screening Visit through End of Study

• individuals of reproductive potential must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control and until 2 weeks after the last dose of study drug in the last treatment period. Acceptable methods of birth control include: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, or vasectomy.

Exclusion Criteria:

• abnormal baseline endoscopy and/or an oral exam

• baseline oral exam showing evidence of oral lesions, such as herpes labialis or aphthous stomatitis, or known self-reported history or current periodontal gum disease

• history of impaired swallowing or difficulties swallowing foods and liquids

• known, history of, or suspected gastrointenstinal disease, including bowel perforation, obstruction, fecal impaction; irritable bowel syndrome (IBS), delayed gastric emptying, gastroparesis, gastroesophageal reflux disease (GERD), gastritis or peptic ulcer disease (PUD), dehydration, inflammatory bowel disease, bowel resection, anal fistulas/fissures, colostomy, etc.

• severe or unexplained abdominal pain

• history of or current alcohol or drug abuse

• history of malignancy ≤5 years prior to signing the informed consent, except for adequately treated basal cell and/or squamous cell skin cancer or in situ cervical cancer

• history of psychiatric illness requiring medications or hospitalization within the previous 12 months

• history of concurrent illness that required hospitalization within 4 weeks prior to Day -1 of the study

• allergies or allergic reactions or intolerance to any of the products used in study

• any degree of renal impairment

• major surgery or clinically significant illness within 4 weeks prior to Day -1 of Visit 1

• current or recent (within the past 30 days of signing informed consent) participation in a study with an investigational compound or device

• refusal to agree not to donate eggs or sperm upon the first study drug administration and thereafter through 90 days after the last study drug administration

• individual is an employee or family member of an employee of the sponsor or clinical unit where study will be conducted