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

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