To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation
Condition: Opioid Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: Polyethylene Glycol 3350; Movantik
Intervention description: Polyethylene Glycol 3350, 17 grams of powder to be dissolved in 4 to 8 ounces of water, juice, soda, coffee or tea to be taken once a day.
Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.; Movantik 25 mg, 1 tablet taken once a day on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal.
Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours.
Intervention MeSH terms: Naloxegol; Polyethylene glycol 3350
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 276.0
Sex: All
Minimum age: 18 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: Opioid Induced constipation,; constipation,; laxative,; bowel movement,; Movantik,; Naloxegol

Summary:

      The purpose of this study is to determine whether patients with opioid induced constipation
      prefer treatment with naloxegol (Movantik) or with Polyethylene Glycol 3350.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between the ages of ≥18 and <85 years

          -  Self-reported active symptoms of OIC (Opioid Induced Constipation) based on components
             of the Rome IV criteria at screening. Patients should have at least 2 of the
             following:

               -  <3 SBMs (Spontaneous Bowel Movements) per week

               -  Straining >25% of defecations

               -  Sensation of incomplete evacuation >25% of defecations

               -  Lumpy or hard stools >25% of defecations

               -  Sensation of anorectal obstruction/blockage >25% of defecations

          -  Confirmed OIC by BFI (Bowel Function Index) ≥30

          -  Stable maintenance opioid regimen consisting of a total daily dose of at least 30 mg
             of oral morphine, or equivalent of 1 or more other opioid therapies

          -  Willingness to stop all laxatives and other bowel regimens other than specified rescue
             medication

        Exclusion Criteria:

          -  Pain related to cancer or has a history of cancer within 5 years

          -  Current constipation or chronic constipation not caused by or related to use of
             opioids

          -  History of rectal evacuation disorders, surgery or procedures that can potentially
             affect pelvic floor function; requirement of using manual maneuvers to facilitate a
             bowel movement

          -  Evidence of significant GI structural abnormalities, acute or chronic GI conditions
             that could post risk to the patient or confound the study results

          -  Recent surgery that may affect GI motility or increase risk for bowel obstruction or
             perforation

          -  Severe hepatic impairment

          -  Moderate or severe renal impairment

          -  Condition that may affect the permeability of blood-brain barrier

          -  Concomitantly using strong or moderate CYP3A4 inhibitors and strong CYP3A4 inducers

          -  Any other significant and/or progressive medical, surgical, psychiatric, or mental
             health condition or any significant laboratory findings that could increase the risk
             of participation in the study or affect the interpretation of study data as determined
             by the Investigator