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



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 84
Updated:7/15/2018
Start Date:March 2, 2017
End Date:August 23, 2017

Use our guide to learn which trials are right for you!

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
We found this trial at
49
sites
?
mi
from
Decatur, GA
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Beavercreek, OH
Click here to add this to my saved trials
?
mi
from
Biloxi, MS
Click here to add this to my saved trials
?
mi
from
Bloomington, IL
Click here to add this to my saved trials
?
mi
from
Brownsburg, IN
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Collegeville, Pennsylvania 19426
?
mi
from
Collegeville, PA
Click here to add this to my saved trials
?
mi
from
DeLand, FL
Click here to add this to my saved trials
?
mi
from
Edmond, OK
Click here to add this to my saved trials
?
mi
from
Endwell, NY
Click here to add this to my saved trials
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
?
mi
from
Greer, SC
Click here to add this to my saved trials
?
mi
from
High Point, NC
Click here to add this to my saved trials
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
?
mi
from
Kingsport, TN
Click here to add this to my saved trials
?
mi
from
Lake City, FL
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Levittown, PA
Click here to add this to my saved trials
?
mi
from
Lincoln, CA
Click here to add this to my saved trials
?
mi
from
Los Gatos, CA
Click here to add this to my saved trials
?
mi
from
Marietta, GA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami Springs, FL
Click here to add this to my saved trials
North Hollywood, California 91606
?
mi
from
North Hollywood, CA
Click here to add this to my saved trials
North Miami Beach, Florida 33162
?
mi
from
North Miami Beach, FL
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Pikesville, MD
Click here to add this to my saved trials
?
mi
from
Plantation, FL
Click here to add this to my saved trials
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Trenton, NJ
Click here to add this to my saved trials
?
mi
from
Troy, MI
Click here to add this to my saved trials
?
mi
from
Waltham, MA
Click here to add this to my saved trials
?
mi
from
West Jordan, UT
Click here to add this to my saved trials
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
?
mi
from
Westminster, CA
Click here to add this to my saved trials
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
?
mi
from
Wyoming, MI
Click here to add this to my saved trials