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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Incline Village, Nevada 89452
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Alexandria, Virginia 22304
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Anaheim, California 92807
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Arlington, Texas 76014
351
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Atlanta, Georgia 30341
801
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Bala Cynwyd, Pennsylvania 19004
1221
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Baltimore, Maryland 21201
1148
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Bellingham, Washington 98225
1445
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Beuna Park, California 90620
1160
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Birmingham, Alabama 35249
676
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Bloomington, Illinois 61701
509
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Boston, Massachusetts 02115
1444
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Brandon, Florida 33511
1126
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Brooksville, Florida 34613
1093
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Brownwood, Texas 76801
422
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Burbank, California 91505
1171
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Calera, Alabama 35040
700
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Charleston, South Carolina 29425
1063
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Charlotte, North Carolina 28203
957
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Chaska, Minnesota 55318
533
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Chesapeake, Virginia 23320
1187
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Christiansburg, Virginia 24073
954
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Cincinnati, Ohio 45229
727
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Colleyville, Texas 76034
338
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Columbus, Ohio 43219
815
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Concord, North Carolina 28025
968
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Danville, Virginia 24541
1016
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Dawsonville, Georgia 30534
798
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Dayton, Ohio 45420
749
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Decatur, Georgia 30033
805
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DeLand, Florida 32720
1124
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Detroit, Michigan 48202
841
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Duarte, California 91010
1152
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East Syracuse, New York 13057
1197
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Edmonds, Washington 98026
1416
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Elizabeth, New Jersey 07201
1276
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Elkhart, Indiana 46514
684
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Elkridge, Maryland 21075
1143
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Eugene, Oregon 97401
1382
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Evansville, Indiana 47714
561
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Fenton, Missouri 63026
404
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Fort Meyers, Florida 33907
1208
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Fountain Valley, California 92708
1160
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Gainsville, Florida 32610
1049
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Galveston, Texas 77555
608
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Glendale, Arizona 85304
854
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Greensboro, North Carolina 27403
999
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Haddon Heights, New Jersey 08035
1230
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Hollywood, Florida 33021
1310
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Hot Springs, Arkansas 71913
347
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Houston, Texas 77030
572
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Huntington Beach, California 92647
1162
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Indianapolis, Indiana 46202
643
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Jacksonville, Florida 32207
1058
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Jupiter, Florida 33458
1272
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Lacey, Washington 98516
1419
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Lake Jackson, Texas 77566
615
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Largo, Florida 33770
1103
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Las Vegas, Nevada 89102
963
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Lexington, Kentucky 40504
723
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Little Rock, Arkansas 72205
368
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Louisville, Kentucky 40202
657
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Manchester, Missouri 63021
401
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Marietta, Georgia 30060
788
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Maumee, Ohio 43537
797
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Medford, Oregon 97504
1357
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Melbourne, Florida 32935
1193
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Miami, Florida 33136
1320
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Mission Viejo, California 92691
1147
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Murrells Inlet, South Carolina 29576
1091
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Muscle Shoals, Alabama 35662
602
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Nazareth, Pennsylvania 18064
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New York, New York 10032
1290
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Newark, Delaware 19713
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Newburgh, Indiana 47630
568
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Niceville, Florida 32578
817
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North Miami, Florida 33161
1316
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Ocala, Florida 34471
1080
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Oklahoma City, Oklahoma 73112
155
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Omaha, Nebraska 68131
262
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Orange, California 92868
1154
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Oregon City, Oregon 97045
1377
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Orlando, Florida 32806
1144
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Ormond Beach, Florida 32174
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Phoenix, Arizona 85012
850
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Picayune, Mississippi 39466
682
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Portage, Michigan 49024
716
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Portland, Oregon 97227
1384
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Princeton, New Jersey 08540
1251
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Redlands, California 92374
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Rockford, Illinois 61107
557
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Saginaw, Michigan 48602
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Salisbury, North Carolina 28114
908
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San Antonio, Texas 78258
561
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San Diego, California 92111
1139
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Sarasota, Florida 34232
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Shreveport, Louisiana 71103
429
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Spartanburg, South Carolina 29303
902
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Spokane, Washington 99208
1208
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St. Louis, Missouri 63110
415
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St. Petersburg, Florida 33707
1113
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