Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC)



Status:Completed
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:10/6/2017
Start Date:November 2013
End Date:April 2015

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A Randomized, 4-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC) in Patients With Non-malignant Chronic Pain Receiving Opioid Therapy

The purpose of this study is to evaluate the safety and efficacy of a range of oral SP-333
doses for the treatment of opioid-induced constipation (OIC) in adults with non-cancer pain
taking opioids.


Inclusion Criteria:

- Must be receiving chronic, stable opioid therapy to treat non-malignant pain for at
least 3 months prior to screening

- Must have active OIC at screening

- Active OIC must be confirmed during baseline screening bowel habit and symptom diary

- Must be on stable diet

Exclusion Criteria:

- Has history of chronic therapy for chronic constipation prior to start of opioid
therapy, or any potential non-opioid cause of bowel dysfunction that may be a major
contributor to the constipation (i.e., mechanical obstruction or pseudo-obstruction)

- Use of medications that might affect bowel movement frequency or constipation-related
symptoms (e.g., prokinetics, anti-diarrheal agents, laxatives other than study-defined
rescue laxative)

- Has history of or current cancer (other than basal cell or squamous cell carcinoma of
the skin) unless the malignancy has been in complete remission without maintenance
chemotherapy for at least 5 years

- Unstable thyroid disease
We found this trial at
43
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Plantation, Florida 33317
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Arlington, Texas 76012
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Artesia, California 90701
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Atlanta, Georgia 30312
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Bloomington, Illinois 61701
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Chattanooga, Tennessee 37421
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Concord, North Carolina 28025
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Dallas, Texas 75231
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Dallas, Texas 75231
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Dayton, Ohio 45424
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Great Neck, New York 11023
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Greensboro, North Carolina 27403
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Hialeah, Florida 33012
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Houston, Texas 77081
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Huntsville, Alabama 35801
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Laguna Hills, California 92653
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Las Vegas, Nevada 89102
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Medford, Oregon 97504
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Medford, OR
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Miami, Florida 33173
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Miami Beach, Florida 33140
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Mobile, Alabama 36608
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New York, New York 10016
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Oceanside, California 92056
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Oklahoma City, Oklahoma 73119
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Oklahoma City, Oklahoma 73119
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Oklahoma City, Oklahoma 73119
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Orangeburg, South Carolina 29118
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Phoenix, Arizona 85029
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Phoenix, Arizona 85029
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Plant City, Florida 33563
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Port Orange, Florida 32129
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Sacramento, California 95831
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Saint Louis, Missouri 63117
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Salisbury, North Carolina 28144
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San Antonio, Texas 78209
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San Diego, California 92103
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San Diego, California 92103
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San Francisco, California 94103
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Sarasota, Florida 34239
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Traverse City, Michigan 49684
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West Palm Beach, Florida 33409
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Winston-Salem, North Carolina 27103
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Winter Haven, Florida 33880
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