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!

Trial Summary
Trial Overview
Inclusion Criteria

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
GSK Investigational Site
Dayton, Ohio 45420
1964
mi
from 98109
Dayton, OH
Click here to add this to my saved trials
GSK Investigational Site
Alexandria, Virginia 22304
2321
mi
from 98109
Alexandria, VA
Click here to add this to my saved trials
GSK Investigational Site
Anaheim, California 92807
981
mi
from 98109
Anaheim, CA
Click here to add this to my saved trials
GSK Investigational Site
Arlington, Texas 76014
1673
mi
from 98109
Arlington, TX
Click here to add this to my saved trials
GSK Investigational Site
Atlanta, Georgia 30341
2176
mi
from 98109
Atlanta, GA
Click here to add this to my saved trials
GSK Investigational Site
Bala Cynwyd, Pennsylvania 19004
2368
mi
from 98109
Bala Cynwyd, PA
Click here to add this to my saved trials
GSK Investigational Site
Baltimore, Maryland 21201
2327
mi
from 98109
Baltimore, MD
Click here to add this to my saved trials
GSK Investigational Site
Bellingham, Washington 98225
77
mi
from 98109
Bellingham, WA
Click here to add this to my saved trials
GSK Investigational Site
Beuna Park, California 90620
979
mi
from 98109
Beuna Park, CA
Click here to add this to my saved trials
GSK Investigational Site
Birmingham, Alabama 35249
2072
mi
from 98109
Birmingham, AL
Click here to add this to my saved trials
GSK Investigational Site
Bloomington, Illinois 61701
1713
mi
from 98109
Bloomington, IL
Click here to add this to my saved trials
GSK Investigational Site
Boston, Massachusetts 02115
2485
mi
from 98109
Boston, MA
Click here to add this to my saved trials
GSK Investigational Site
Brandon, Florida 33511
2536
mi
from 98109
Brandon, FL
Click here to add this to my saved trials
GSK Investigational Site
Brooksville, Florida 34613
2501
mi
from 98109
Brooksville, FL
Click here to add this to my saved trials
GSK Investigational Site
Brownwood, Texas 76801
1647
mi
from 98109
Brownwood, TX
Click here to add this to my saved trials
GSK Investigational Site
Burbank, California 91505
953
mi
from 98109
Burbank, CA
Click here to add this to my saved trials
GSK Investigational Site
Calera, Alabama 35040
2099
mi
from 98109
Calera, AL
Click here to add this to my saved trials
GSK Investigational Site
Charleston, South Carolina 29425
2422
mi
from 98109
Charleston, SC
Click here to add this to my saved trials
GSK Investigational Site
Charlotte, North Carolina 28203
2281
mi
from 98109
Charlotte, NC
Click here to add this to my saved trials
GSK Investigational Site
Chaska, Minnesota 55318
1379
mi
from 98109
Chaska, MN
Click here to add this to my saved trials
GSK Investigational Site
Chesapeake, Virginia 23320
2437
mi
from 98109
Chesapeake, VA
Click here to add this to my saved trials
GSK Investigational Site
Christiansburg, Virginia 24073
2228
mi
from 98109
Christiansburg, VA
Click here to add this to my saved trials
GSK Investigational Site
Cincinnati, Ohio 45229
1966
mi
from 98109
Cincinnati, OH
Click here to add this to my saved trials
GSK Investigational Site
Colleyville, Texas 76034
1661
mi
from 98109
Colleyville, TX
Click here to add this to my saved trials
GSK Investigational Site
Columbus, Ohio 43219
2009
mi
from 98109
Columbus, OH
Click here to add this to my saved trials
GSK Investigational Site
Concord, North Carolina 28025
2286
mi
from 98109
Concord, NC
Click here to add this to my saved trials
GSK Investigational Site
Danville, Virginia 24541
2296
mi
from 98109
Danville, VA
Click here to add this to my saved trials
GSK Investigational Site
Dawsonville, Georgia 30534
2163
mi
from 98109
Dawsonville, GA
Click here to add this to my saved trials
GSK Investigational Site
Decatur, Georgia 30033
2181
mi
from 98109
Decatur, GA
Click here to add this to my saved trials
GSK Investigational Site
DeLand, Florida 32720
2527
mi
from 98109
DeLand, FL
Click here to add this to my saved trials
GSK Investigational Site
Detroit, Michigan 48202
1931
mi
from 98109
Detroit, MI
Click here to add this to my saved trials
GSK Investigational Site
Duarte, California 91010
959
mi
from 98109
Duarte, CA
Click here to add this to my saved trials
GSK Investigational Site
East Syracuse, New York 13057
2234
mi
from 98109
East Syracuse, NY
Click here to add this to my saved trials
GSK Investigational Site
Edmonds, Washington 98026
13
mi
from 98109
Edmonds, WA
Click here to add this to my saved trials
GSK Investigational Site
Elizabeth, New Jersey 07201
2394
mi
from 98109
Elizabeth, NJ
Click here to add this to my saved trials
GSK Investigational Site
Elkhart, Indiana 46514
1816
mi
from 98109
Elkhart, IN
Click here to add this to my saved trials
GSK Investigational Site
Elkridge, Maryland 21075
2326
mi
from 98109
Elkridge, MD
Click here to add this to my saved trials
GSK Investigational Site
Eugene, Oregon 97401
249
mi
from 98109
Eugene, OR
Click here to add this to my saved trials
GSK Investigational Site
Evansville, Indiana 47714
1868
mi
from 98109
Evansville, IN
Click here to add this to my saved trials
GSK Investigational Site
Fenton, Missouri 63026
1713
mi
from 98109
Fenton, MO
Click here to add this to my saved trials
GSK Investigational Site
Fort Meyers, Florida 33907
2619
mi
from 98109
Fort Meyers, FL
Click here to add this to my saved trials
GSK Investigational Site
Fountain Valley, California 92708
988
mi
from 98109
Fountain Valley, CA
Click here to add this to my saved trials
GSK Investigational Site
Gainsville, Florida 32610
2453
mi
from 98109
Gainsville, FL
Click here to add this to my saved trials
GSK Investigational Site
Galveston, Texas 77555
1937
mi
from 98109
Galveston, TX
Click here to add this to my saved trials
GSK Investigational Site
Glendale, Arizona 85304
1104
mi
from 98109
Glendale, AZ
Click here to add this to my saved trials
GSK Investigational Site
Greensboro, North Carolina 27403
2295
mi
from 98109
Greensboro, NC
Click here to add this to my saved trials
GSK Investigational Site
Haddon Heights, New Jersey 08035
2380
mi
from 98109
Haddon Heights, NJ
Click here to add this to my saved trials
GSK Investigational Site
Hollywood, Florida 33021
2720
mi
from 98109
Hollywood, FL
Click here to add this to my saved trials
GSK Investigational Site
Hot Springs, Arkansas 71913
1759
mi
from 98109
Hot Springs, AR
Click here to add this to my saved trials
GSK Investigational Site
Houston, Texas 77030
1892
mi
from 98109
Houston, TX
Click here to add this to my saved trials
GSK Investigational Site
Huntington Beach, California 92647
987
mi
from 98109
Huntington Beach, CA
Click here to add this to my saved trials
GSK Investigational Site
Incline Village, Nevada 89452
588
mi
from 98109
Incline Village, NV
Click here to add this to my saved trials
GSK Investigational Site
Indianapolis, Indiana 46202
1867
mi
from 98109
Indianapolis, IN
Click here to add this to my saved trials
GSK Investigational Site
Jacksonville, Florida 32207
2454
mi
from 98109
Jacksonville, FL
Click here to add this to my saved trials
GSK Investigational Site
Jupiter, Florida 33458
2680
mi
from 98109
Jupiter, FL
Click here to add this to my saved trials
GSK Investigational Site
Lacey, Washington 98516
47
mi
from 98109
Lacey, WA
Click here to add this to my saved trials
GSK Investigational Site
Lake Jackson, Texas 77566
1922
mi
from 98109
Lake Jackson, TX
Click here to add this to my saved trials
GSK Investigational Site
Largo, Florida 33770
2513
mi
from 98109
Largo, FL
Click here to add this to my saved trials
GSK Investigational Site
Las Vegas, Nevada 89102
874
mi
from 98109
Las Vegas, NV
Click here to add this to my saved trials
GSK Investigational Site
Lexington, Kentucky 40504
2003
mi
from 98109
Lexington, KY
Click here to add this to my saved trials
GSK Investigational Site
Little Rock, Arkansas 72205
1779
mi
from 98109
Little Rock, AR
Click here to add this to my saved trials
GSK Investigational Site
Louisville, Kentucky 40202
1939
mi
from 98109
Louisville, KY
Click here to add this to my saved trials
GSK Investigational Site
Manchester, Missouri 63021
1707
mi
from 98109
Manchester, MO
Click here to add this to my saved trials
GSK Investigational Site
Marietta, Georgia 30060
2163
mi
from 98109
Marietta, GA
Click here to add this to my saved trials
GSK Investigational Site
Maumee, Ohio 43537
1927
mi
from 98109
Maumee, OH
Click here to add this to my saved trials
GSK Investigational Site
Medford, Oregon 97504
367
mi
from 98109
Medford, OR
Click here to add this to my saved trials
GSK Investigational Site
Melbourne, Florida 32935
2598
mi
from 98109
Melbourne, FL
Click here to add this to my saved trials
GSK Investigational Site
Miami, Florida 33136
2730
mi
from 98109
Miami, FL
Click here to add this to my saved trials
GSK Investigational Site
Mission Viejo, California 92691
999
mi
from 98109
Mission Viejo, CA
Click here to add this to my saved trials
GSK Investigational Site
Murrells Inlet, South Carolina 29576
2432
mi
from 98109
Murrells Inlet, SC
Click here to add this to my saved trials
GSK Investigational Site
Muscle Shoals, Alabama 35662
1988
mi
from 98109
Muscle Shoals, AL
Click here to add this to my saved trials
GSK Investigational Site
Nazareth, Pennsylvania 18064
2340
mi
from 98109
Nazareth, PA
Click here to add this to my saved trials
GSK Investigational Site
New York, New York 10032
2400
mi
from 98109
New York, NY
Click here to add this to my saved trials
GSK Investigational Site
Newark, Delaware 19713
2357
mi
from 98109
Newark, DE
Click here to add this to my saved trials
GSK Investigational Site
Newburgh, Indiana 47630
1874
mi
from 98109
Newburgh, IN
Click here to add this to my saved trials
GSK Investigational Site
Niceville, Florida 32578
2228
mi
from 98109
Niceville, FL
Click here to add this to my saved trials
GSK Investigational Site
North Miami, Florida 33161
2726
mi
from 98109
North Miami, FL
Click here to add this to my saved trials
GSK Investigational Site
Ocala, Florida 34471
2485
mi
from 98109
Ocala, FL
Click here to add this to my saved trials
GSK Investigational Site
Oklahoma City, Oklahoma 73112
1519
mi
from 98109
Oklahoma City, OK
Click here to add this to my saved trials
GSK Investigational Site
Omaha, Nebraska 68131
1365
mi
from 98109
Omaha, NE
Click here to add this to my saved trials
GSK Investigational Site
Orange, California 92868
984
mi
from 98109
Orange, CA
Click here to add this to my saved trials
GSK Investigational Site
Oregon City, Oregon 97045
157
mi
from 98109
Oregon City, OR
Click here to add this to my saved trials
GSK Investigational Site
Orlando, Florida 32806
2549
mi
from 98109
Orlando, FL
Click here to add this to my saved trials
GSK Investigational Site
Ormond Beach, Florida 32174
2527
mi
from 98109
Ormond Beach, FL
Click here to add this to my saved trials
GSK Investigational Site
Phoenix, Arizona 85012
1112
mi
from 98109
Phoenix, AZ
Click here to add this to my saved trials
GSK Investigational Site
Picayune, Mississippi 39466
2089
mi
from 98109
Picayune, MS
Click here to add this to my saved trials
GSK Investigational Site
Portage, Michigan 49024
1819
mi
from 98109
Portage, MI
Click here to add this to my saved trials
GSK Investigational Site
Portland, Oregon 97227
145
mi
from 98109
Portland, OR
Click here to add this to my saved trials
GSK Investigational Site
Princeton, New Jersey 08540
2383
mi
from 98109
Princeton, NJ
Click here to add this to my saved trials
GSK Investigational Site
Redlands, California 92374
975
mi
from 98109
Redlands, CA
Click here to add this to my saved trials
GSK Investigational Site
Rockford, Illinois 61107
1653
mi
from 98109
Rockford, IL
Click here to add this to my saved trials
GSK Investigational Site
Saginaw, Michigan 48602
1861
mi
from 98109
Saginaw, MI
Click here to add this to my saved trials
GSK Investigational Site
Salisbury, North Carolina 28114
2239
mi
from 98109
Salisbury, NC
Click here to add this to my saved trials
GSK Investigational Site
San Antonio, Texas 78258
1776
mi
from 98109
San Antonio, TX
Click here to add this to my saved trials
GSK Investigational Site
San Diego, California 92111
1058
mi
from 98109
San Diego, CA
Click here to add this to my saved trials
GSK Investigational Site
Sarasota, Florida 34232
2556
mi
from 98109
Sarasota, FL
Click here to add this to my saved trials
GSK Investigational Site
Shreveport, Louisiana 71103
1820
mi
from 98109
Shreveport, LA
Click here to add this to my saved trials
GSK Investigational Site
Spartanburg, South Carolina 29303
2240
mi
from 98109
Spartanburg, SC
Click here to add this to my saved trials
GSK Investigational Site
Spokane, Washington 99208
226
mi
from 98109
Spokane, WA
Click here to add this to my saved trials
GSK Investigational Site
St. Louis, Missouri 63110
1718
mi
from 98109
St. Louis, MO
Click here to add this to my saved trials
GSK Investigational Site
St. Petersburg, Florida 33707
2524
mi
from 98109
St. Petersburg, FL
Click here to add this to my saved trials