Trial · NCT01696643
Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
NCT01696643, Phase 3, Terminated, Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2015-09-28
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ConductScience Library. Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation. Trials, record NCT01696643. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01696643
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
- NCT number
- NCT01696643
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,407 participants, actual
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Opioid-Induced Constipation
- Interventions
- CB-5945, Placebo
- First posted
- 2012-10-01
- Last updated
- 2018-11-15
- Results first posted
- 2015-09-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline through Week 56 | A TEAE was defined as any adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing AEs that were aggravated in severity or frequency during the dosing period. The percentages of participants with at least 1 TEAE, with at least 1 drug-related TEAE (drug-related included "possibly related" or "related" as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE are presented. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. |
| Secondary | Change From Baseline in Mean Daily Opioid Dose at Weeks 49-52 | Baseline, Weeks 49-52 | Throughout the study, participants were asked to record changes in maintenance opioid consumption and use of opioid analgesics for breakthrough or exacerbation of pain in a paper diary. Opioid consumption (including rescue opioids) of each participant was converted to an oral morphine-equivalent total daily dose (METDD). Opioid consumption (in milligrams of METDD) was summarized in 4-week intervals. The change from baseline to Weeks 49-52 is summarized. |
| Secondary | Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire at Week 52 | Baseline, Week 52 | The PAC-QOL questionnaire contains a total of 28 items, each rated within 4 subscales: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. Each item was rated on a 5-point Likert scale with the following score definitions, depending on the question: 0 = not at all (or none of the time), 1 = a little bit (or a little of the time), 2 = moderately (or some of the time), 3 = quite a bit (or most of the time), and 4 = extremely (or all of the time). The total score is the mean of all non-missing items. The range of the total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). Negative change from baseline values indicate improvement in constipation quality of life. Each participant completed the PAC-QOL at Baseline and Week 52 using a 2-week recall period. |
| Secondary | Change From Baseline in Patient-Reported Constipation Severity Assessment (PCSA) at Week 52 | Baseline, Week 52 | The PCSA asked participants to rate the severity of their overall constipation during the 24 hours prior to the assessment, using a scale of 0 to 10, where 0 is no constipation and 10 is the worst constipation imaginable. |
| Secondary | Plasma Trough Concentrations of CB-5945 | Weeks 4, 12, 24, 36, and 52 | Blood samples for trough concentrations of CB-5945 were collected before the participant's morning dose of study drug at Weeks 4, 12, 24, 36, and 52. Overall concentration was based on the mean trough level for each participant across all weeks. |
| Other | Number of Participants With Adjudicated Cardiovascular, Gastrointestinal, or Central Opioid Withdrawal Events | Baseline through Week 56 | Cardiovascular (CV) events of interested included mycardial infarction, unstable angina, CV accident, congestive heart failure, serious arrhythmia, resuscitated cardiac arrest, and death. Gastrointestinal (GI) events of interest included emergency department visits for the serious adverse events of gastroenteritis, hepatitis, pancreatitis, nausea, vomiting, diarrhea, and abdominal pain or cramping. Central opioid withdrawal (OW) events of interest included opioid withdrawal syndrome. The adverse events that indicated central OW included, but were not limited to, hyperhidrosis, tremor, dysphoria, and myalgia. The number of participants with at least 1 confirmed CV, GI, or Central OW event is presented. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline through Week 56 | All randomized participants who received at least 1 dose of study drug. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Mean Daily Opioid Dose at Weeks 49-52 | Baseline, Weeks 49-52 | All randomized participants who received at least 1 dose of study drug and had evaluable METDD data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis. | milligrams of METDD | MEAN |
| SECONDARY | Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire at Week 52 | Baseline, Week 52 | All randomized participants who received at least 1 dose of study drug and had evaluable PAC-QOL data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient-Reported Constipation Severity Assessment (PCSA) at Week 52 | Baseline, Week 52 | All randomized participants who received at least 1 dose of study drug and had evaluable PCSA data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis. | units on a scale | MEAN |
| SECONDARY | Plasma Trough Concentrations of CB-5945 | Weeks 4, 12, 24, 36, and 52 | All participants randomized to CB-5945 who received at least 1 dose of study drug and had evaluable CB-5945 concentration data. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis. | picograms per milliliter (pg/mL) | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Adjudicated Cardiovascular, Gastrointestinal, or Central Opioid Withdrawal Events | Baseline through Week 56 | All randomized participants who received at least 1 dose of study drug. Two participants were randomized to the Placebo Arm but were administered CB-5945 instead. As a result, these 2 participants were included in the CB-5945 Arm for analysis. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | CB-5945 | Had at least 1 TEAE | 58.5 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo | Had at least 1 TEAE | 54.0 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | CB-5945 | Had at least 1 drug-related TEAE | 19.9 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo | Had at least 1 drug-related TEAE | 12.1 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | CB-5945 | Discontinued treatment due to a TEAE | 10.0 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | Placebo | Discontinued treatment due to a TEAE | 5.7 | percentage of participants | |
| Change From Baseline in Mean Daily Opioid Dose at Weeks 49-52 | CB-5945 | -12.456 | Standard Deviation 90.2190 | milligrams of METDD | |
| Change From Baseline in Mean Daily Opioid Dose at Weeks 49-52 | Placebo | -12.297 | Standard Deviation 88.8681 | milligrams of METDD | |
| Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire at Week 52 | CB-5945 | -0.63 | Standard Deviation 0.699 | units on a scale | |
| Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire at Week 52 | Placebo | -0.45 | Standard Deviation 0.583 | units on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CB-5945 | 703 | |
| Overall Study | STARTED | Placebo | 704 | |
| Overall Study | Received at Least 1 Dose of Study Drug | CB-5945 | 701 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 702 | |
| Overall Study | COMPLETED | CB-5945 | 174 | |
| Overall Study | COMPLETED | Placebo | 169 | |
| Overall Study | NOT COMPLETED | CB-5945 | 529 | |
| Overall Study | NOT COMPLETED | Placebo | 535 |
Source ClinicalTrials.gov
Adverse events1,102
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | CB-5945 | 90 | 703 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 33 | 700 | |
| other | Abdominal Pain | Gastrointestinal disorders | CB-5945 | 57 | 703 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 32 | 700 | |
| other | Nausea | Gastrointestinal disorders | CB-5945 | 51 | 703 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 39 | 700 | |
| other | Vomiting | Gastrointestinal disorders | CB-5945 | 35 | 703 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 20 | 700 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | CB-5945 | 20 | 703 | |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Placebo | 11 | 700 |
1 to 10 of 1,102Source ClinicalTrials.gov
See all 1,102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CB-5945 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | CB-5945 | 403 | 703 |
| Total, other adverse events | Placebo | 373 | 700 |
| Total, serious adverse events | CB-5945 | 40 | 703 |
| Total, serious adverse events | Placebo | 36 | 700 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| CB-5945 vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01696643
GET https://conductscience.org/api/trials/v1/NCT01696643/results?page=2