Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:June 2008
End Date:February 2013

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

A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes

This study will evaluate the safety and efficacy of methylnaltrexone administered as
subcutaneous injections in subjects who have opioid-induced constipation and an advanced
illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving
opioid-induced constipation in these subjects.


Inclusion Criteria:

- Is an adult 18 years of age or older

- Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer
or other end-stage disease)

- Has a life expectancy of at least 1 month.

- Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for
the control of pain or discomfort for at least 2 weeks before the first dose of study
drug.

- Has constipation that is caused by opioid medications.

Exclusion Criteria:

- Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g.
naltrexone or naloxone).

- Has a known or suspected mechanical gastrointestinal obstruction.

- Has any potential nonopioid cause of bowel dysfunction that might be a major
contributor to the constipation.

- Has any other clinically important abnormalities as determined by the investigator
that may interfere with his or her participation in or compliance with the study.

- Receiving opioid antagonist or partial antagonist products.
We found this trial at
27
sites
Philadelphia, Pennsylvania 19111
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Albuquerque, New Mexico 87108
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
American Fork, Utah 84003
?
mi
from
American Fork, UT
Click here to add this to my saved trials
Auburndale, Florida 33823
?
mi
from
Auburndale, FL
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Austin, Texas 78757
?
mi
from
Austin, TX
Click here to add this to my saved trials
Cleveland, Ohio 44119
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Darlinghurst, New South Wales 2010
?
mi
from
Darlinghurst,
Click here to add this to my saved trials
Flat Rock, North Carolina 28731
?
mi
from
Flat Rock, NC
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Hudson, Florida 34667
?
mi
from
Hudson, FL
Click here to add this to my saved trials
Laguna Hills, California 92637
?
mi
from
Laguna Hills, CA
Click here to add this to my saved trials
Lakeland, Florida 33805
?
mi
from
Lakeland, FL
Click here to add this to my saved trials
Lancaster, California 93534
?
mi
from
Lancaster, CA
Click here to add this to my saved trials
Madison, Wisconsin 53792
?
mi
from
Madison, WI
Click here to add this to my saved trials
Miami Springs, Florida 33166
?
mi
from
Miami Springs, FL
Click here to add this to my saved trials
Mobile, Alabama 36604
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Orange, New Jersey 07018
?
mi
from
Orange, NJ
Click here to add this to my saved trials
Orem, Utah 84058
?
mi
from
Orem, UT
Click here to add this to my saved trials
Provo, Utah 84604
?
mi
from
Provo, UT
Click here to add this to my saved trials
Ruskin, Florida 33573
?
mi
from
Ruskin, FL
Click here to add this to my saved trials
Salt Lake City, Utah 84132
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Sebring, Florida 33870
?
mi
from
Sebring, FL
Click here to add this to my saved trials
Tampa, Florida 33619
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Temple Terrace, Florida 33617
?
mi
from
Temple Terrace, FL
Click here to add this to my saved trials
West Palm Beach, Florida 33407
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials