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
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Redlands, California 92374
47
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Alexandria, Virginia 22304
2277
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Anaheim, California 92807
20
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Arlington, Texas 76014
1208
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Atlanta, Georgia 30341
1922
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Bala Cynwyd, Pennsylvania 19004
2371
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Baltimore, Maryland 21201
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Bellingham, Washington 98225
1040
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Beuna Park, California 90620
15
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Birmingham, Alabama 35249
1777
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Bloomington, Illinois 61701
1647
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Boston, Massachusetts 02115
2578
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Brandon, Florida 33511
2146
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Brooksville, Florida 34613
2126
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Brownwood, Texas 76801
1113
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Burbank, California 91505
19
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Calera, Alabama 35040
1793
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Charleston, South Carolina 29425
2184
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Charlotte, North Carolina 28203
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Chaska, Minnesota 55318
1489
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Chesapeake, Virginia 23320
2342
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Christiansburg, Virginia 24073
2109
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Cincinnati, Ohio 45229
1880
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Colleyville, Texas 76034
1202
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Columbus, Ohio 43219
1965
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Concord, North Carolina 28025
2114
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Danville, Virginia 24541
2169
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Dawsonville, Georgia 30534
1926
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Dayton, Ohio 45420
1900
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Decatur, Georgia 30033
1924
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DeLand, Florida 32720
2177
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Detroit, Michigan 48202
1965
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Duarte, California 91010
5
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East Syracuse, New York 13057
2322
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Edmonds, Washington 98026
976
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Elizabeth, New Jersey 07201
2422
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Elkhart, Indiana 46514
1812
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Elkridge, Maryland 21075
2296
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Eugene, Oregon 97401
741
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Evansville, Indiana 47714
1716
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Fenton, Missouri 63026
1559
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Fort Meyers, Florida 33907
2205
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Fountain Valley, California 92708
25
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Gainsville, Florida 32610
2104
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Galveston, Texas 77555
1401
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Glendale, Arizona 85304
336
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Greensboro, North Carolina 27403
2150
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Haddon Heights, New Jersey 08035
2381
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Hollywood, Florida 33021
2315
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Hot Springs, Arkansas 71913
1421
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Houston, Texas 77030
1357
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Huntington Beach, California 92647
24
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Incline Village, Nevada 89452
376
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Indianapolis, Indiana 46202
1793
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Jacksonville, Florida 32207
2131
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Jupiter, Florida 33458
2296
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Lacey, Washington 98516
929
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Lake Jackson, Texas 77566
1367
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Largo, Florida 33770
2117
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Las Vegas, Nevada 89102
214
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Lexington, Kentucky 40504
1879
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Little Rock, Arkansas 72205
1459
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Louisville, Kentucky 40202
1813
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Manchester, Missouri 63021
1556
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Marietta, Georgia 30060
1908
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Maumee, Ohio 43537
1931
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Medford, Oregon 97504
628
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Melbourne, Florida 32935
2235
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Miami, Florida 33136
2321
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Mission Viejo, California 92691
37
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Murrells Inlet, South Carolina 29576
2223
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Muscle Shoals, Alabama 35662
1723
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Nazareth, Pennsylvania 18064
2364
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New York, New York 10032
2435
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Newark, Delaware 19713
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Newburgh, Indiana 47630
1723
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Niceville, Florida 32578
1850
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North Miami, Florida 33161
2319
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Ocala, Florida 34471
2127
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Oklahoma City, Oklahoma 73112
1161
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Omaha, Nebraska 68131
1299
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Orange, California 92868
21
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Oregon City, Oregon 97045
816
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Orlando, Florida 32806
2186
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Ormond Beach, Florida 32174
2186
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Phoenix, Arizona 85012
343
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Picayune, Mississippi 39466
1667
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Portage, Michigan 49024
1837
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Portland, Oregon 97227
829
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Princeton, New Jersey 08540
2399
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Rockford, Illinois 61107
1660
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Saginaw, Michigan 48602
1929
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Salisbury, North Carolina 28114
2051
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San Antonio, Texas 78258
1184
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San Diego, California 92111
99
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Sarasota, Florida 34232
2151
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Shreveport, Louisiana 71103
1401
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Spartanburg, South Carolina 29303
2042
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Spokane, Washington 99208
947
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St. Louis, Missouri 63110
1570
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St. Petersburg, Florida 33707
2125
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