Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone



Status:Completed
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2007
End Date:March 2009

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A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)

The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone
administration in patients with opioid-induced bowel dysfunction (OBD).


Inclusion Criteria:

- Consistent treatment for chronic, non-cancer-related pain with any full agonist
opioid for at least 30 days prior to screening.

- Diagnosis of opioid-induced bowel dysfunction as confirmed during the screening
period.

- If patient has a history of chronic constipation, condition must have been
exacerbated by initiation of opioid treatment.

- Use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal
motility (other than opioid therapy) must be discontinued during the study.

- If treated for clinical depression with selective serotonin reuptake inhibitors
(SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase
(MAO) inhibitors, treatment must have been at a stable dose for at least 30 days
prior to screening.

- Use of laxative and stool softeners (with the exception of approved rescue
medications) must be discontinued while on study.

Exclusion Criteria:

- Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of
administration within 30 days of screening.

- Non-ambulatory patients, or those who are unable to eat/drink, take oral medications,
or to hold down oral medications due to vomiting.

- Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma,
and/or for the management of drug addiction.

- Patient has been treated for cancer in the past 5 years (with the exception of
localized basal cell, squamous cell skin cancer, or in situ cancer that has been
resected).

- Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.

- Female patients of childbearing potential who are unable/unwilling to use
protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan
to become pregnant or nurse during the study.
We found this trial at
110
sites
Edmonton, Alberta
1321
mi
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Edmonton,
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3635 S. Clyde Morris Blvd
Port Orange, Florida 32129
386-760-3862
About Us Accord Clinical Research is a privately owned research facility, founded in Port Orange,...
1132
mi
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Port Orange, FL
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4243 Sunbeam Road
Jacksonville, Florida 32257
1063
mi
from
Jacksonville, FL
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8420 S. Eastern Ave.
Las Vegas, Nevada 89123
702-898-2088
961
mi
from
Las Vegas, NV
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707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
400
mi
from
Longview, TX
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3100 Wellons Blvd.
New Bern, North Carolina 28562
252-634-9000
1164
mi
from
New Bern, NC
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11045 N. 19th Avenue
Phoenix, Arizona 85029
602-395-1200
850
mi
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Phoenix, AZ
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
777
mi
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Salt Lake City, UT
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3212 Cove Bend Drive
Tampa, Florida 33613
1112
mi
from
Tampa, FL
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1208
mi
from
Allentown, PA
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Arcadia, California 91007
1156
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Asheboro, North Carolina 27203
1006
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Asheboro, NC
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Augusta, Georgia 30901
936
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Augusta, GA
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Bakersfield, California 93311
1185
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Baltimore, Maryland 21228
1141
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Bellevue, Washington 98004
1404
mi
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Bellevue, WA
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1299
mi
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Boca Raton, FL
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1444
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Boston, MA
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751
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from
Calhoun, GA
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Cedar Knolls, New Jersey 07927
1263
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Cedar Knolls, NJ
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Centerville, Ohio
747
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Chesterfield, Michigan 48098
842
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Chesterfield, MI
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Chicago, Illinois 60616
609
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Chicago, IL
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Chicago, Illinois 60617
609
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Chicago, IL
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Chino, California 91710
1139
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Christianburg, Virginia 24073
953
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Cincinnati, Ohio 45238
728
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Colorado Springs, Colorado 80904
386
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1136
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Columbia, MD
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809
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Columbus, OH
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Dayton, Ohio 45432
752
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Dayton, OH
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Decatur, Georgia 30035
811
mi
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Decatur, GA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
1052
mi
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Durham, NC
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Edina, Minnesota 55435
544
mi
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Edina, MN
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Elizabeth, New Jersey 07202
1275
mi
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Elizabeth, NJ
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Evansville, Indiana 47714
561
mi
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Evansville, IN
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Evansville, Indiana 47714
561
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Flowood, Mississippi 39232
574
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Flowood, MS
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Greenville, North Carolina 27834
1133
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Greenville, NC
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1089
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Hagerstown, MD
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Harrisburg, North Carolina 28075
966
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HIgh Point, North Carolina 27262
990
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HIgh Point, NC
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Huntington Beach, California 92647
1162
mi
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Huntington Beach, CA
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342
mi
from
Hurst, TX
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Indianapolis, Indiana 46260
643
mi
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Indianapolis, IN
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Interlochen, Michigan 49643
785
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Interlochen, MI
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Jupiter, Florida 33458
1272
mi
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Jupiter, FL
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
190
mi
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Knoxville, Tennessee 37920
777
mi
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Lafayette, Louisiana 70508
620
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Laguna Hills, California 92637
1149
mi
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415
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Lakewood, CO
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Lansing, Michigan 48917
774
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Las Vegas, Nevada 89146
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Lexington, North Carolina 27295
979
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Little Rock, Arkansas 72205
368
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Littleton, Colorado 80120
408
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Littleton, Colorado 80122
408
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Loma Linda, California 92354
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Long Beach, California 90822
1167
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
656
mi
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Louisville, KY
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Marion, Ohio 43302
809
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Marion, OH
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Medford, Oregon 97504
1357
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Medford, OR
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Milan, Tennessee 38358
516
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1036
mi
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Missoula, MT
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Monroe, Louisiana 71201
484
mi
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Monroe, LA
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Naples, Florida 34102
1231
mi
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Naples, FL
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New York, New York 10004
1284
mi
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New York, NY
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1288
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New York, NY
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New York, New York 10022
1286
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Niceville, Florida 32578
817
mi
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Niceville, FL
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North Miami, Florida 33161
1316
mi
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Ocala, Florida 34471
1077
mi
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Ogden, Utah 84405
790
mi
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Ogden, UT
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
158
mi
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Oklahoma City, OK
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Oklahoma City, Oklahoma 73112
158
mi
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Oklahoma City, OK
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Oklahoma City, Oklahoma 73134
158
mi
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601 N 30th St
Omaha, Nebraska 68131
(402) 449-4000
Creighton University Medical Center St. Joseph's Mercy Hospital was founded on September 25, 1870 at...
262
mi
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Ormond Beach, Florida 32174
1126
mi
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Paw Paw, Michigan 49079
701
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Paw Paw, MI
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Philadelphia, Pennsylvania 19414
1225
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Phoenix, Arizona 85012
851
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Phoenix, Arizona 85050
842
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Pinellas Park, Florida 33782
1109
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Pinellas Park, FL
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Plantation, Florida 33324
1302
mi
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Plantation, FL
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1179
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Portsmouth, VA
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Richardson, Texas 75082
334
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Richardson, TX
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Richmond, Virginia 23249
1110
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Rochester, Minnesota 55905
515
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Rochester, MN
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Salt Lake City, Utah 84124
775
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San Francisco, California 94117
1181
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Sarasota, Florida 34233
1147
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Shreveport, Louisiana 71103
429
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Shreveport, LA
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Spokane, Washington 99204
1202
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Spokane, WA
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St. Louis, Missouri 63117
411
mi
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St. Louis, MO
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St. Petersburg, Florida
1118
mi
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St. Petersburg, FL
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5115 North Armenia Avenue
Tampa, Florida 33603
1114
mi
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Tampa, FL
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1286
mi
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Teaneck, NJ
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845
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Tempe, AZ
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847
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Tempe, AZ
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798
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Toledo, OH
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