Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain



Status:Completed
Conditions:Constipation, Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2005
End Date:May 2006

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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain

Adults who are taking opioid therapy for persistent non-cancer pain and have resulting
opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one 2 alvimopan arms,
or to placebo. The primary objective of this phase 3 confirmatory study is to compare
alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint
is based on frequency of bowel movements. Subjects will be required to: (1) track their
bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.


Inclusion criteria:

- Has consented to participate in this study.

- Taking opioid therapy for persistent non-cancer pain.

- Has bowel dysfunction mainly due to opioids.

- Has bowel dysfunction since starting opioids as defined by infrequent bowel movements
and additional bowel-related symptoms.

- Willing to discontinue laxative therapy (will be provided study-specific standardized
laxative if needed).

- Willing to report daily bowel symptoms.

Exclusion criteria:

- Pregnant, lactating, or planning to become pregnant.

- Not ambulatory.

- Participated in another trial with an investigational drug in the past 30 days.

- Taking opioids for the management of drug addiction or cancer-related pain.

- Severe constipation whereby the subject is at immediate risk of developing serious
complications of constipation.

- Gastrointestinal or pelvic disorders known to affect bowel transit, produce
gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.

- HIV-infected, has active hepatitis, or has ever been infected with hepatitis C.
We found this trial at
118
sites
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Alexandria, Virginia 22304
?
mi
from
Alexandria, VA
Click here to add this to my saved trials
Anaheim, California 92807
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
Arlington, Texas 76014
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Atlanta, Georgia 30341
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Bala Cynwyd, Pennsylvania 19004
?
mi
from
Bala Cynwyd, PA
Click here to add this to my saved trials
Baltimore, Maryland 21201
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bellingham, Washington 98225
?
mi
from
Bellingham, WA
Click here to add this to my saved trials
Beuna Park, California 90620
?
mi
from
Beuna Park, CA
Click here to add this to my saved trials
Birmingham, Alabama 35249
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Bloomington, Illinois 61701
?
mi
from
Bloomington, IL
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
Brandon, Florida 33511
?
mi
from
Brandon, FL
Click here to add this to my saved trials
Brooksville, Florida 34613
?
mi
from
Brooksville, FL
Click here to add this to my saved trials
Brownwood, Texas 76801
?
mi
from
Brownwood, TX
Click here to add this to my saved trials
Burbank, California 91505
?
mi
from
Burbank, CA
Click here to add this to my saved trials
Calera, Alabama 35040
?
mi
from
Calera, AL
Click here to add this to my saved trials
Charleston, South Carolina 29425
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28203
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chaska, Minnesota 55318
?
mi
from
Chaska, MN
Click here to add this to my saved trials
Chesapeake, Virginia 23320
?
mi
from
Chesapeake, VA
Click here to add this to my saved trials
Christiansburg, Virginia 24073
?
mi
from
Christiansburg, VA
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Colleyville, Texas 76034
?
mi
from
Colleyville, TX
Click here to add this to my saved trials
Columbus, Ohio 43219
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Concord, North Carolina 28025
?
mi
from
Concord, NC
Click here to add this to my saved trials
Danville, Virginia 24541
?
mi
from
Danville, VA
Click here to add this to my saved trials
Dawsonville, Georgia 30534
?
mi
from
Dawsonville, GA
Click here to add this to my saved trials
Dayton, Ohio 45420
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Decatur, Georgia 30033
?
mi
from
Decatur, GA
Click here to add this to my saved trials
DeLand, Florida 32720
?
mi
from
DeLand, FL
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Duarte, California 91010
?
mi
from
Duarte, CA
Click here to add this to my saved trials
East Syracuse, New York 13057
?
mi
from
East Syracuse, NY
Click here to add this to my saved trials
Edmonds, Washington 98026
?
mi
from
Edmonds, WA
Click here to add this to my saved trials
Elizabeth, New Jersey 07201
?
mi
from
Elizabeth, NJ
Click here to add this to my saved trials
Elkhart, Indiana 46514
?
mi
from
Elkhart, IN
Click here to add this to my saved trials
Elkridge, Maryland 21075
?
mi
from
Elkridge, MD
Click here to add this to my saved trials
Eugene, Oregon 97401
?
mi
from
Eugene, OR
Click here to add this to my saved trials
Evansville, Indiana 47714
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Fenton, Missouri 63026
?
mi
from
Fenton, MO
Click here to add this to my saved trials
Fort Meyers, Florida 33907
?
mi
from
Fort Meyers, FL
Click here to add this to my saved trials
Fountain Valley, California 92708
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Gainsville, Florida 32610
?
mi
from
Gainsville, FL
Click here to add this to my saved trials
Galveston, Texas 77555
?
mi
from
Galveston, TX
Click here to add this to my saved trials
Glendale, Arizona 85304
?
mi
from
Glendale, AZ
Click here to add this to my saved trials
Greensboro, North Carolina 27403
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Haddon Heights, New Jersey 08035
?
mi
from
Haddon Heights, NJ
Click here to add this to my saved trials
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Hot Springs, Arkansas 71913
?
mi
from
Hot Springs, AR
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
Huntington Beach, California 92647
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Incline Village, Nevada 89452
?
mi
from
Incline Village, NV
Click here to add this to my saved trials
Jacksonville, Florida 32207
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jupiter, Florida 33458
?
mi
from
Jupiter, FL
Click here to add this to my saved trials
Lacey, Washington 98516
?
mi
from
Lacey, WA
Click here to add this to my saved trials
Lake Jackson, Texas 77566
?
mi
from
Lake Jackson, TX
Click here to add this to my saved trials
Largo, Florida 33770
?
mi
from
Largo, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89102
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lexington, Kentucky 40504
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Manchester, Missouri 63021
?
mi
from
Manchester, MO
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Maumee, Ohio 43537
?
mi
from
Maumee, OH
Click here to add this to my saved trials
Medford, Oregon 97504
?
mi
from
Medford, OR
Click here to add this to my saved trials
Melbourne, Florida 32935
?
mi
from
Melbourne, FL
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Mission Viejo, California 92691
?
mi
from
Mission Viejo, CA
Click here to add this to my saved trials
Murrells Inlet, South Carolina 29576
?
mi
from
Murrells Inlet, SC
Click here to add this to my saved trials
Muscle Shoals, Alabama 35662
?
mi
from
Muscle Shoals, AL
Click here to add this to my saved trials
Nazareth, Pennsylvania 18064
?
mi
from
Nazareth, PA
Click here to add this to my saved trials
New York, New York 10032
?
mi
from
New York, NY
Click here to add this to my saved trials
Newark, Delaware 19713
?
mi
from
Newark, DE
Click here to add this to my saved trials
Newburgh, Indiana 47630
?
mi
from
Newburgh, IN
Click here to add this to my saved trials
Niceville, Florida 32578
?
mi
from
Niceville, FL
Click here to add this to my saved trials
North Miami, Florida 33161
?
mi
from
North Miami, FL
Click here to add this to my saved trials
Ocala, Florida 34471
?
mi
from
Ocala, FL
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Omaha, Nebraska 68131
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Orange, California 92868
?
mi
from
Orange, CA
Click here to add this to my saved trials
Oregon City, Oregon 97045
?
mi
from
Oregon City, OR
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Ormond Beach, Florida 32174
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
Phoenix, Arizona 85012
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Picayune, Mississippi 39466
?
mi
from
Picayune, MS
Click here to add this to my saved trials
Portage, Michigan 49024
?
mi
from
Portage, MI
Click here to add this to my saved trials
Portland, Oregon 97227
?
mi
from
Portland, OR
Click here to add this to my saved trials
Princeton, New Jersey 08540
?
mi
from
Princeton, NJ
Click here to add this to my saved trials
Redlands, California 92374
?
mi
from
Redlands, CA
Click here to add this to my saved trials
Rockford, Illinois 61107
?
mi
from
Rockford, IL
Click here to add this to my saved trials
Saginaw, Michigan 48602
?
mi
from
Saginaw, MI
Click here to add this to my saved trials
Salisbury, North Carolina 28114
?
mi
from
Salisbury, NC
Click here to add this to my saved trials
San Antonio, Texas 78258
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92111
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Sarasota, Florida 34232
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Shreveport, Louisiana 71103
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Spartanburg, South Carolina 29303
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
Spokane, Washington 99208
?
mi
from
Spokane, WA
Click here to add this to my saved trials
St. Louis, Missouri 63110
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
St. Petersburg, Florida 33707
?
mi
from
St. Petersburg, FL
Click here to add this to my saved trials