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

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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
Lacey, Washington 98516
2030
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Lacey, WA
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Alexandria, Virginia 22304
325
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Anaheim, California 92807
1953
mi
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Arlington, Texas 76014
928
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Arlington, TX
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Atlanta, Georgia 30341
424
mi
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Bala Cynwyd, Pennsylvania 19004
412
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Baltimore, Maryland 21201
343
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GSK Investigational Site
Bellingham, Washington 98225
2016
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Beuna Park, California 90620
1965
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GSK Investigational Site
Birmingham, Alabama 35249
493
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GSK Investigational Site
Bloomington, Illinois 61701
316
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GSK Investigational Site
Boston, Massachusetts 02115
643
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Boston, MA
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GSK Investigational Site
Brandon, Florida 33511
834
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Brandon, FL
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GSK Investigational Site
Brooksville, Florida 34613
789
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Brownwood, Texas 76801
1058
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GSK Investigational Site
Burbank, California 91505
1974
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GSK Investigational Site
Calera, Alabama 35040
517
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GSK Investigational Site
Charleston, South Carolina 29425
524
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GSK Investigational Site
Charlotte, North Carolina 28203
348
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Chaska, Minnesota 55318
633
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Chaska, MN
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Chesapeake, Virginia 23320
430
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Christiansburg, Virginia 24073
241
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Cincinnati, Ohio 45229
96
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Colleyville, Texas 76034
923
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Colleyville, TX
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GSK Investigational Site
Columbus, Ohio 43219
7
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Concord, North Carolina 28025
341
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Danville, Virginia 24541
305
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Dawsonville, Georgia 30534
387
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Dayton, Ohio 45420
60
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Decatur, Georgia 30033
430
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Decatur, GA
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GSK Investigational Site
DeLand, Florida 32720
761
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Detroit, Michigan 48202
165
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Detroit, MI
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Duarte, California 91010
1955
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Duarte, CA
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East Syracuse, New York 13057
418
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East Syracuse, NY
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Edmonds, Washington 98026
2007
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Edmonds, WA
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Elizabeth, New Jersey 07201
466
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Elizabeth, NJ
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Elkhart, Indiana 46514
194
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Elkhart, IN
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Elkridge, Maryland 21075
339
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Eugene, Oregon 97401
2055
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Evansville, Indiana 47714
278
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Fenton, Missouri 63026
409
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Fort Meyers, Florida 33907
928
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Fountain Valley, California 92708
1966
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Gainsville, Florida 32610
714
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Galveston, Texas 77555
992
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Glendale, Arizona 85304
1663
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Greensboro, North Carolina 27403
320
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Haddon Heights, New Jersey 08035
421
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Hollywood, Florida 33021
977
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Hot Springs, Arkansas 71913
667
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Houston, Texas 77030
995
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Huntington Beach, California 92647
1968
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Incline Village, Nevada 89452
1949
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Indianapolis, Indiana 46202
166
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Jacksonville, Florida 32207
672
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Jupiter, Florida 33458
915
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Lake Jackson, Texas 77566
1032
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Largo, Florida 33770
832
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Largo, FL
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Las Vegas, Nevada 89102
1759
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Lexington, Kentucky 40504
156
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Little Rock, Arkansas 72205
625
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Louisville, Kentucky 40202
188
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Manchester, Missouri 63021
411
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Marietta, Georgia 30060
423
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Maumee, Ohio 43537
115
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Medford, Oregon 97504
2060
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Melbourne, Florida 32935
827
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Miami, Florida 33136
992
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Mission Viejo, California 92691
1953
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Murrells Inlet, South Carolina 29576
494
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Muscle Shoals, Alabama 35662
441
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Nazareth, Pennsylvania 18064
409
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New York, New York 10032
481
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Newark, Delaware 19713
388
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Newburgh, Indiana 47630
273
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Niceville, Florida 32578
681
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North Miami, Florida 33161
986
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Ocala, Florida 34471
748
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Oklahoma City, Oklahoma 73112
851
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Omaha, Nebraska 68131
683
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Orange, California 92868
1959
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Oregon City, Oregon 97045
2024
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Orlando, Florida 32806
797
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Ormond Beach, Florida 32174
746
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Phoenix, Arizona 85012
1660
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Picayune, Mississippi 39466
752
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Portage, Michigan 49024
203
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Portland, Oregon 97227
2026
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Princeton, New Jersey 08540
441
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Redlands, California 92374
1915
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Rockford, Illinois 61107
353
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Rockford, IL
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Saginaw, Michigan 48602
243
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Saginaw, MI
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Salisbury, North Carolina 28114
334
mi
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Salisbury, NC
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San Antonio, Texas 78258
1126
mi
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San Antonio, TX
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GSK Investigational Site
San Diego, California 92111
1948
mi
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San Diego, CA
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Sarasota, Florida 34232
873
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Sarasota, FL
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Shreveport, Louisiana 71103
789
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Shreveport, LA
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Spartanburg, South Carolina 29303
349
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Spartanburg, SC
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Spokane, Washington 99208
1781
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Spokane, WA
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St. Louis, Missouri 63110
397
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St. Petersburg, Florida 33707
844
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