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| ID | Type | Description | Link |
|---|---|---|---|
| 5945-OIC-12-03 | Other Identifier | Cubist Study Number |
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Sponsor decision due to lack of enrollment.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CB-5945 | Experimental | 0.25 milligrams (mg) CB-5945 administered orally twice dailly (BID) for a 12-week treatment period |
|
| Placebo | Placebo Comparator | Placebo administered orally BID for a 12-week treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CB-5945 | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Spontaneous Bowel Movement (SBM) Responder Rates at 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adjudicated Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events | 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. |
Key Inclusion Criteria:
Key Exclusion Criteria:
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Due to difficulties with enrollment, this study was terminated early.
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| ID | Title | Description |
|---|---|---|
| FG000 | CB-5945 | 0.25 milligrams (mg) CB-5945 administered orally twice dailly (BID) for a 12-week treatment period |
| FG001 | Placebo | Placebo administered orally BID for a 12-week treatment period |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants randomized to treatment who received ≥ 1 dose of double-blind study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | CB-5945 | 0.25 mg CB-5945 administered orally BID for a 12-week treatment period |
| BG001 | Placebo | Placebo administered orally BID for a 12-week treatment period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Spontaneous Bowel Movement (SBM) Responder Rates at 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). | Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early. | Posted | 12 weeks |
|
Baseline through 16 weeks
SAEs that occurred before the first dose of double-blind study medication were only included in the safety database.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CB-5945 | 0.25 mg CB-5945 administered orally BID for a 12-week treatment period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
Due to difficulties with enrollment, this study was terminated early.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Research | Cubist Pharmaceuticals | (781) 860-8660 |
| ID | Term |
|---|---|
| D000079689 | Opioid-Induced Constipation |
| D003248 | Constipation |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
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| Drug |
|
| Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 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 |
| Baseline through 16 weeks |
| Protocol Violation |
|
| Study Terminated by Sponsor |
|
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | Placebo administered orally BID for a 12-week treatment period |
|
| Secondary | Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 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"). | Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early. | Posted | Baseline, 12 weeks |
|
|
| Secondary | Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 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). | Zero participants were analyzed, and no data was collected for this measure. Due to lack of enrollment, the study was terminated early. | Posted | 12 weeks |
|
|
| Other Pre-specified | Adjudicated Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events | 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. | Posted | Number | participants | Baseline through 16 weeks |
|
|
|
| 0 |
| 26 |
| 10 |
| 26 |
| EG001 | Placebo | Placebo administered orally BID for a 12-week treatment period | 0 | 23 | 4 | 23 |
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Drug withdrawal syndrome | General disorders | Systematic Assessment |
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| Acute sinusitis | Infections and infestations | Systematic Assessment |
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| Bronchitis | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Sensory loss | Nervous system disorders | Systematic Assessment |
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| Fall | General disorders | Systematic Assessment |
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| Flatulence | Injury, poisoning and procedural complications | Systematic Assessment |
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| Rash erythematous | Infections and infestations | Systematic Assessment |
|
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| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D009461 | Neurologic Manifestations |
| Subjects with at Least One Confirmed OW Event |
|