- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01901328
Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo administered orally BID for a 12-week treatment period
|
|
Experimental: CB-5945
0.25 milligrams (mg) CB-5945 administered orally twice dailly (BID) for a 12-week treatment period
|
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Spontaneous Bowel Movement (SBM) Responder Rates at 12-weeks
Time Frame: 12 weeks
|
A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week.
For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks
Time Frame: Baseline, 12 weeks
|
The CORGISS is designed to assess GI symptoms related to opioid use in patients with chronic non-cancer pain.
The CORGISS asks participants to rate the severity of GI symptoms over the previous 24 hours, with answers ranging from 0 ("did not experience") to 4 ("very severe").
|
Baseline, 12 weeks
|
Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 12 Weeks
Time Frame: 12 weeks
|
A CSBM Weekly Responder is a subject who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week.
An Overall CSBM Responder is a subject who is a Weekly CSBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adjudicated Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events
Time Frame: Baseline through 16 weeks
|
Cardiovascular (CV) events of interested included myocardial infarction, unstable angina, cardiovascular accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death. Gastrointestinal (GI) events of interest included emergency department visits for SAEs of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping. Central opioid withdrawal events of interest included opioid withdrawal syndrome. |
Baseline through 16 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2402-004
- 5945-OIC-12-03 (Other Identifier: Cubist Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Opioid-Induced Constipation
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Amsterdam UMC, location VUmcRadboud University Medical Center; University Medical Center Groningen; UMC Utrecht and other collaboratorsRecruitingConstipation, Opioid-InducedNetherlands
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Kyowa Kirin Pharmaceutical Development LtdTerminatedOpioid Induced ConstipationNetherlands, United Kingdom
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Valinor Pharma LLCActive, not recruiting
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Theravance BiopharmaCompletedOpioid Induced ConstipationUnited States
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St. John Health System, MichiganUnknownOpioid-induced ConstipationUnited States
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ShionogiRecruitingOpioid-Induced Constipation (OIC)France
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AstraZenecaCompletedOpioid-Induced Constipation (OIC)United States, Australia, Slovakia, Germany
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AstraZenecaCompletedOpioid-Induced Constipation (OIC)United States
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Yeditepe University HospitalCompletedTherapeutic Opioid Induced Constipation (Disorder)
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