Safety and Tolerability of Oral Polyethylene Glycol (PEG 3350) Solution in Participants With Constipation (MK-8114-003)
Condition: Constipation
MeSH terms: Constipation
Intervention: Polyethylene Glycol (PEG 3350); Placebo; Bisacodyl laxative tablets (rescue medication)
Intervention description: Oral 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days.; Oral 17 g dose of Placebo solution concentrate in a volume of approximately 30 mL, once a day, for 14 days.; 5.0 mg tablets, 1 to 3 tablets in a single daily dose, to be provided for use as rescue medication if participant has not had bowel movement for 72 hours after start of treatment.
Intervention MeSH terms: Bisacodyl; Polyethylene glycol 3350; Laxatives
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility 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