Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation



Status:Terminated
Conditions:Constipation
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:July 2013
End Date:April 2014

Use our guide to learn which trials are right for you!

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of CB-5945 for the Treatment of Opioid-Induced Constipation in Adults Taking Opioid Therapy for Chronic Non-Cancer Pain

The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the
treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic
non-cancer pain.

This is a multicenter, double-blind, placebo-controlled, parallel-group study in
participants with OIC taking opioid therapy for chronic non-cancer pain. Approximately 600
participants (300 participants per treatment group) with OIC will be randomized at
approximately 75 study centers to receive either oral 0.25 mg CB-5945 BID or oral matching
placebo BID for the 12-week double-blind treatment period, followed by a 4-week follow-up
period. All randomized participants will be evaluated for clinical response for duration of
their study participation. All participants will be followed for safety for 4 weeks after
last dose of the study medication, regardless of when they discontinue study medication. The
clinical study report for this study includes pooled results for studies 5945-OIC-12-02
(NCT01901302) 5945-OIC-12-03 (NCT01901328), and 5945-OIC-12-04 (NCT01901341).

Key Inclusion Criteria:

- Is taking a stable daily dose of opioids of ≥30 mg morphine equivalent total daily
dose (METDD) for chronic non-cancer pain

- Has constipation that is caused by the chronic use of opioids

- Is willing to use only the study provided laxative(s) and to discontinue use of all
other laxatives, enemas, stool softeners, and other medications to treat constipation
(e.g., lubiprostone) from Screening until the last study assessment

Key Exclusion Criteria:

- Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for
example [e.g.], obstruction) or contribute to bowel dysfunction

- Has evidence of intestinal obstruction

- Has a history of rectal bleeding not due to hemorrhoids or fissures within 6 months
of screening

- Has an active malignancy of any type (participants with a history of successfully
treated malignancy >5 years before the scheduled administration of study medication
and participants with treated basal or squamous cell cancer may be enrolled)

- Is taking antispasmodics (e.g., dicyclomine), antidiarrheals (e.g., loperamide),
prokinetics (e.g., metoclopramide), or locally acting chloride channel activators
(e.g., lubiprostone)

- Is taking non-opioid medications known to cause constipation (e.g., iron sulfate
therapy, tricyclic antidepressants)
We found this trial at
70
sites
?
mi
from
Evansville, IN
Click here to add this to my saved trials
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Altoona, PA
Click here to add this to my saved trials
?
mi
from
Athens, GA
Click here to add this to my saved trials
?
mi
from
Austell, GA
Click here to add this to my saved trials
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
?
mi
from
Bingham Farms, MI
Click here to add this to my saved trials
?
mi
from
Blackwood, NJ
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
?
mi
from
Brandon, FL
Click here to add this to my saved trials
?
mi
from
Brookville, FL
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
?
mi
from
Carlsbad, CA
Click here to add this to my saved trials
?
mi
from
Centerville, OH
Click here to add this to my saved trials
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Clermont, FL
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
?
mi
from
Cumberland, RI
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Elkhorn, NE
Click here to add this to my saved trials
?
mi
from
Fresno, CA
Click here to add this to my saved trials
?
mi
from
Gulf Shores, AL
Click here to add this to my saved trials
?
mi
from
Hartsdale, NY
Click here to add this to my saved trials
?
mi
from
Hazelwood, MO
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Interlochen, MI
Click here to add this to my saved trials
?
mi
from
Jenkintown, PA
Click here to add this to my saved trials
?
mi
from
Kissimee, FL
Click here to add this to my saved trials
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Maitland, FL
Click here to add this to my saved trials
?
mi
from
Mentor, OH
Click here to add this to my saved trials
?
mi
from
Mesa, AZ
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Monroe, LA
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Newnan, GA
Click here to add this to my saved trials
?
mi
from
Norco, CA
Click here to add this to my saved trials
?
mi
from
North Little Rock, AR
Click here to add this to my saved trials
North Richland Hills, Texas 76180
?
mi
from
North Richland Hills, TX
Click here to add this to my saved trials
?
mi
from
Ocala, FL
Click here to add this to my saved trials
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Royal Palm Beach, FL
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
?
mi
from
Scottsdale, AZ
Click here to add this to my saved trials
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
St. George, UT
Click here to add this to my saved trials
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
?
mi
from
Stamford, CT
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Troy, MI
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials
?
mi
from
Woodstock, GA
Click here to add this to my saved trials