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
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Gainesville, Florida 32607
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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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Garden Grove, California 92845
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Gold River, California 95670
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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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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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Mentor, Ohio 44060
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Metairie, Louisiana 77002
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North Hollywood, California 91606
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Orange, California 92868
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Oviedo, Florida 32765
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Tulsa, Oklahoma 74135
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