Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication



Status:Completed
Conditions:Constipation, Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:8/31/2017
Start Date:October 1, 2003
End Date:May 1, 2006

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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of
an investigational drug for the treatment of constipation due to prescription pain medication
in subjects with cancer pain. The study will require five visits over a five-week period.


Inclusion criteria:

- Participant is in any stage of cancer but has a minimum life expectancy of at least 3
months at the time of the Screening Visit.

- Participant is taking opioid therapy for persistent cancer pain.

- Participant meets the definition of opioid-induced bowel dysfunction as follows: Since
starting opioid therapy, the subject has had decreased bowel movement (BM) frequency
and at least one of the following constipation symptoms [sensation of incomplete
evacuation, difficulty in expelling stool (straining), hard stools (abnormal stool
consistency)].

- Participant understands the procedures, agrees to participate in the study, and has
signed and dated the informed consent form prior to the initiation of any
study-related activities, including discontinuation of pre-study laxative regimen or
other prohibited medications.

- Participant is able and willing to comply with a daily paper diary and is capable of
completing paper questionnaires at study visits.

Exclusion criteria:

- Participant is pregnant or lactating, or planning to become pregnant.

- Participant is not ambulatory.

- Participant has participated in another trial with an investigational drug
(unapproved), device or procedure within 30 days of the Screening Visit.

- Participant is unable to eat, drink, take/hold down oral medications.

- Participant is taking opioids for the management of drug addiction.

- Participant is unable or unwilling to discontinue the use of and/or refrain from using
laxatives of all types and formulation at the Screening Visit and throughout the
entire study.

- Participant has severe constipation that has not been appropriately managed such that
the subject is at immediate risk of developing serious complications of constipation.
This would include a subject who has reported no bowel movement for 7 consecutive days
prior to the Screening Visit.

- Participant with gastrointestinal or pelvic disorders known to affect bowel transit,
produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.

- Participant is currently taking vinca alkyloids or plans to take vinca alkyloids
during the study.

- Participant is currently undergoing abdominal radiation therapy and/or plans to
undergo abdominal radiation therapy during the study.

- Participant is human immunodeficiency virus (HIV)-infected, has active hepatitis (any
subtype including ongoing chronic hepatitis B), or has ever been infected with
hepatitis C.
We found this trial at
62
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Chapel Hill, North Carolina 27599
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Albuquerque, New Mexico 87109
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Amarillo, Texas 79106
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Ann Arbor, Michigan 48109
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Baltimore, Maryland 21201
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Bethesda, Maryland 20892
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Bethpage, New York 11714
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Bismarck, North Dakota 58501
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Boston, Massachusetts 02115
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Canton, Ohio 44708
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Capital Federal, Buenos Aires
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Charlotte, North Carolina 28203
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Chicago, Illinois 60611
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Decatur, Georgia 30033
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Denver, Colorado 80206
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Duarte, California 91010
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Durham, North Carolina 27705
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Flint, Michigan 48504
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Fountain Valley, California 92708
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Fresno, California 93720
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Gainesville, Florida 32610
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Hendersonville, North Carolina 28739
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Hot Springs, Arkansas 71913
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Houston, Texas 77030
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Huntington Station, New York 11746
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Hutchinson, Kansas 67502
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Inverness, Florida 34452
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Jamaica, New York 11432
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Kansas City, Missouri 64128
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La Verne, California 91750
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Lecanto, Florida 34461
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Los Angeles, California 90025
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Los Gatos, California 95032
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Miami Shores, Florida 33138
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Middletown, Ohio 45042
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Milwaukee, Wisconsin 53215
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Modesto, California 95350
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Nashville, Tennessee 37203
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New Port Richey, Florida 34655
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Norfolk, Virginia 23502
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Ocala, Florida 34471
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Palm Harbor, Florida 34684
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Portland, Oregon 97227
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Portsmouth, Virginia 23704
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Raleigh, North Carolina 27614
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Richmond, Virginia 23298
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Sacramento, California 95815
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Saint Louis, Missouri 63110
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Saint Louis Park, Minnesota 55426
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San Diego, California 92111
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Stuart, Florida 34994
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Tacoma, Washington 98405
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Tampa, Florida 33612
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Tucson, Arizona 85724
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Washington, D.C., District of Columbia 20007
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Webster, Texas 77450
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West Des Moines, Iowa 50265
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Winston-Salem, North Carolina 27103
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Worcester, Massachusetts 01655
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