To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation

A Phase IV, Randomized, Multi-Center, Open-Label, Prospective, Crossover Study to Evaluate Patient Preference of Movantik™ Versus Polyethylene Glycol 3350 for Opioid-Induced Constipation (OIC) Treatment

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

This study is a prospective, randomized, open-label crossover study consisting of a 1-week washout period, a 2-week treatment period, another 1-week washout and a final 2-week treatment period. The study will assess the overall patient preference Movantik versus Polyethylene Glycol 3350 for the treatment of their opioid-induced constipation. This study will also evaluate the reasons for patient preference (only among subjects who indicate a preference), patient global impression of change, and change in bowel function over the treatment periods measured by Bowel Function Index. Patient's bowel movement diary will also be collected during the study.

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