Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2014
End Date:October 2015

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A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered Orally for 8 Weeks to Adult Outpatients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain

The purpose of this study is to evaluate the safety and efficacy of linaclotide for the
treatment of opioid-induced constipation (OIC), in adults receiving stable opioid treatment
for chronic non-cancer pain that has been present for a minimum of 3 months.

This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period.
Patients meeting the entry criteria will be randomized to 1 of 2 doses of linaclotide or
placebo for 8 weeks. This 8-week study will assess the effects of linaclotide on bowel
movement frequency, as well as other bowel symptoms of OIC.


Inclusion Criteria:

- Patient has chronic non-cancer pain that has been present for a minimum of 3 months

- Patient has been receiving a stable dose of a full-opioid agonist for at least 4 days
per week during the 8 consecutive weeks

- Patient meets protocol criteria for Opioid-Induced Constipation (OIC): < 3
spontaneous bowel movements (SBMs) per week and reports one of the following symptoms
for at least 4 weeks:

1. Straining during > 25% of BMs

2. Lumpy or hard stools during > 25% of BMs

3. Sensation of incomplete evacuation during > 25% of BMs

- Patient meets the colonoscopy requirements defined by the American
Gastroenterological Association guidelines

- Patient has successfully completed protocol procedures (with no clinically
significant findings)

- Patient is compliant with Interactive Voice Response System (IVRS) for daily diary
reporting

- Patient has a total of < 6 SBMs in IVRS during the 14 days before and up to the time
of Randomization

- Patient has adequate relief and well-controlled pain with current dose of opioid

Exclusion Criteria:

- Patient has been using opioids for abdominal pain

- Patient has symptoms of or been diagnosed with chronic constipation or chronic
idiopathic constipation prior to initiation of opioid treatment

- Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS) prior
to initiation of opioid treatment

- Patient has a history of loose or watery stools for > 25% of BMs during the 3 months
before the Screening in the absence of laxatives, suppositories, or enemas

- Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease
or condition that can affect GI motility

- Patient has any protocol-excluded or clinically significant medical or surgical
history that would limit the patient's ability to complete or participate in this
clinical trial or could confound the study assessments
We found this trial at
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North Little Rock, Arkansas 72117
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Anaheim, California 92801
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Anniston, Alabama 36207
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Asheboro, North Carolina 27203
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Bellevue, Washington 98007
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Boynton Beach, Florida 33426
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Bradenton, Florida 34208
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Bristol, Connecticut 06010
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Chapel Hill, North Carolina 27514
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Charleston, South Carolina 29407
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Chesterfield, Michigan 48047
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Chicago, Illinois 60608
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Christiansburg, Virginia 24073
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Cincinnati, Ohio 45219
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Colorado Springs, Colorado 80909
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Colorado Springs, Colorado 80909
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Columbus, Ohio 43213
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Cumberland, Rhode Island 02864
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Davidson, North Carolina 28036
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DeLand, Florida 32720
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Evansville, Indiana 47712
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Fargo, North Dakota 58103
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Flat Rock, North Carolina 28731
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Flint, Michigan 48532
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Foley, Alabama 36535
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Fountain Valley, California 92708
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Fresno, California 93726
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Gainesville, Florida 32607
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Garden Grove, California 92845
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Gold River, California 95670
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Greensboro, North Carolina 27410
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Greensboro, North Carolina 27410
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Hagerstown, Maryland 21742
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Jacksonville, Florida 32216
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Jupiter, Florida 33458
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Lauderdale Lakes, Florida 33319
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Levittown, Pennsylvania 19056
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Lincoln, California 95648
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Logan, Utah 84341
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Madisonville, Kentucky 42431
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Marietta, Georgia 30066
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Medford, Oregon 97504
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Mentor, Ohio 44060
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Metairie, Louisiana 77002
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Miami, Florida 33133
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North Hollywood, California 91606
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Ogden, Utah 84405
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Oklahoma City, Oklahoma 73116
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Omaha, Nebraska 68131
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Orange, California 92868
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Orlando, Florida 32806
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Oviedo, Florida 32765
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Philadelphia, Pennsylvania 19139
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Phoenix, Arizona 85006
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Port Orange, Florida 32127
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Richardson, Texas 75080
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Sacramento, California 95817
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San Antonio, Texas 78229
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San Diego, California 92123
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Santa Ana, California 92701
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Seminole, Florida 33777
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Tampa, Florida 33613
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Tucson, Arizona 85741
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Tulsa, Oklahoma 74135
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Wadsworth, Ohio 44281
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Watertown, Massachusetts 02472
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West Jordan, Utah 84088
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West Palm Beach, Florida 33407
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Weston, Florida 33331
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Williamsville, New York 14221
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Winston Salem, North Carolina 28277
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Woodstock, Georgia 30189
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