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

Information source: Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opioid-Induced Constipation

Intervention: CB-5945 (Drug); Placebo (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Cubist Pharmaceuticals

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Cubist Pharmaceuticals

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Overall Spontaneous Bowel Movement (SBM) Responder Rates at 12 Weeks

Secondary outcome:

Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks

Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 12 Weeks

Detailed description: 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).

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Gulf Shores, Alabama, United States

Mesa, Arizona, United States

Phoenix, Arizona, United States

Scottsdale, Arizona, United States

Tucson, Arizona, United States

Little Rock, Arkansas, United States

North Little Rock, Arkansas, United States

Carlsbad, California, United States

Chula Vista, California, United States

Fresno, California, United States

Long Beach, California, United States

Norco, California, United States

Oceanside, California, United States

Sacramento, California, United States

San Diego, California, United States

Santa Ana, California, United States

Colorado Springs, Colorado, United States

Stamford, Connecticut, United States

Bradenton, Florida, United States

Brandon, Florida, United States

Brookville, Florida, United States

Clermont, Florida, United States

Coral Gables, Florida, United States

Kissimee, Florida, United States

Maitland, Florida, United States

Miami, Florida, United States

Ocala, Florida, United States

Orlando, Florida, United States

Royal Palm Beach, Florida, United States

Sarasota, Florida, United States

Tampa, Florida, United States

Athens, Georgia, United States

Austell, Georgia, United States

Newnan, Georgia, United States

Woodstock, Georgia, United States

Evansville, Indiana, United States

Lexington, Kentucky, United States

Owensboro, Kentucky, United States

Lake Charles, Louisiana, United States

Monroe, Louisiana, United States

Boston, Massachusetts, United States

Bingham Farms, Michigan, United States

Interlochen, Michigan, United States

Troy, Michigan, United States

Hazelwood, Missouri, United States

St. Louis, Missouri, United States

Elkhorn, Nebraska, United States

Las Vegas, Nevada, United States

Berlin, New Jersey, United States

Blackwood, New Jersey, United States

Albuquerque, New Mexico, United States

Hartsdale, New York, United States

New York, New York, United States

Winston-Salem, North Carolina, United States

Canton, Ohio, United States

Centerville, Ohio, United States

Cincinnati, Ohio, United States

Mentor, Ohio, United States

Oklahoma City, Oklahoma, United States

Altoona, Pennsylvania, United States

Jenkintown, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Cumberland, Rhode Island, United States

Dallas, Texas, United States

Houston, Texas, United States

North Richland Hills, Texas, United States

Salt Lake City, Utah, United States

St. George, Utah, United States

Richmond, Virginia, United States

Spokane, Washington, United States

Additional Information

Starting date: July 2013
Last updated: June 4, 2015

Page last updated: August 23, 2015

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