Trial · NCT02031432
CORAL XT - Open-label Extension Trial of the CORAL Trial
NCT02031432, Phase 3, Completed, Tris Pharma, Inc.; results first posted 2020-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CORAL XT - Open-label Extension Trial of the CORAL Trial. Trials, record NCT02031432. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02031432
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CORAL XT - Open-label Extension Trial of the CORAL Trial
- NCT number
- NCT02031432
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 76 participants, actual
- Lead sponsor
- Tris Pharma, Inc.
- Conditions
- Pain, Neoplasms, Chronic Pain
- Interventions
- Cebranopadol
- First posted
- 2014-01-09
- Last updated
- 2021-07-15
- Other registries' IDs
- eudract:2013-001877-26
- Results first posted
- 2020-01-18
- Limitations and caveats
- A limitation is the open-label design of the study. An extrapolation to a population not suffering from cancer-related pain is limited due to the nature of the underlying disorder.
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Event (TEAEs) | Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow up after the last dose) | The safety of cebranopadol was assessed by the number of participants with treatment emergent adverse events (TEAEs). A TEAE was any adverse event that occurred after the first administration of investigational medicinal product (IMP), i.e., cebranopadol in this study. In addition, pretreatment adverse events which worsened during the treatment period were also considered TEAEs. |
| Secondary | Intensity of Treatment Emergent Adverse Events | Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow-up after the last dose) | A Treatment Emergent Adverse Event (TEAE) was defined as any Adverse Event (AE) that occurred on or after the first intake of cebranopadol or a pretreatment AE which worsened during the treatment period. TEAEs were classified by the investigator as falling into 1 of 3 categories: Mild: Signs and symptoms that can be easily tolerated. Symptoms can be ignored and disappear when the participant is distracted. Moderate: Symptoms cause discomfort but are tolerable; they cannot be ignored and affect concentration. Severe: Symptoms which affect usual daily activity. For TEAE where the intensity changed over time, the maximum intensity observed during the whole duration of the adverse event was documented. |
| Secondary | Changes From Baseline in the Average Pain Intensity in the Last Week During the Treatment Period | Baseline Visit (Day 1) to End of Treatment Visit (up to 26 weeks). | Participants were asked "Please rate your pain by selecting the one number that best describes your pain on average during the last week." and scored their average pain intensity during the last week of the treatment period on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The absolute change from baseline for the average pain intensity during the last week was determined for all participants that scored their pain intensities. A mean value for all participants was calculated. |
| Other | Outcome of Treatment Emergent Adverse Events (TEAE) | Baseline (Day 2) to End of trial (i.e., up to Week 28) | The outcome of a TEAE was classified into 1 of the following 6 categories by the investigator, i.e. * Recovered/Resolved. * Recovered/Resolved with sequelae. * Fatal * Recovering/Resolving. * Not recovered/Not resolved. * Unknown (e.g., because the participant is lost to follow up). |
| Other | Time to Onset of Treatment Emergent Adverse Events (TEAEs) | Baseline (Day 2) to End of trial (up to Week 28) | The median time, in days, from the start of the open-label cebranopadol treatment to the start day of the treatment emergent adverse event (TEAE). |
| Other | Duration of Treatment Emergent Adverse Events (TEAEs) | Baseline (Day 2) to End of trial (up to Week 28) | An adverse event is any untoward medical occurrence attributed to cebranopadol. Duration of Adverse Event was calculated as stop date minus start date plus 1 for non-missing and partial dates. |
| Other | Causal Relationship of Treatment Emergent Adverse Events (TEAEs) | Baseline (Day 2) to End of trial (up to Week 28) | The causality of TEAEs was assessed by the investigator as falling into 1 of the following 7 categories: Conditional/Unclassified, Unassessable/Unclassifiable, Not related, Unlikely, Possible, Probable/likely, or Certain. The numbers of TEAEs per category are presented. |
| Other | Countermeasures Taken for Treatment Emergent Adverse Events (TEAEs) | Baseline (Day 2) to End of trial (up to Week 28) | The countermeasure of a Treatment Emergent Adverse Event (TEAE) was classified by the investigator as being a study medication-related countermeasure and based on non-study medication countermeasures. Non-study medication related countermeasures were categorized as being one of the following: No countermeasure given; A newly started medication or change in dose or route of application of a concomitant medication due to the AE; Other countermeasures, e.g., physical therapy, surgery. Study medication-related countermeasures were categorized as being one of the following: Dose not changed; Dose reduced; Drug interrupted; Trial discontinuation. Absolute numbers are per category reported. |
| Other | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Cebranopadol | Baseline (Day 2) to End of trial (up to Week 28) | Only participants with TEAEs which were assessed by the investigator as falling into one of the 3 categories of causality (Possible, Probable/likely, or Certain) were summarized. The initial breakdown planned based on intensity, outcome, time to onset, duration, and countermeasures was not performed and is therefore not reported. |
| Other | Columbia-Suicide Severity Rating Scale (C-SSRS) Scores | Baseline (Day 1) to End of trial (up to Week 28) | The C-SSRS was administered by a clinician who had been certified to administer the C-SSRS at each visit. Suicidal ideation is classified on a 5-item scale (where 1 = Wish to be dead, 2 = Non-specific active suicidal thoughts, 3 = Active Suicidal Ideation with any methods (not plan) without intent to act, 4 = Active Suicidal Ideation with some intent to act, without specific plan, 5 = Active suicidal ideation with a specific plan and intent). The number of participants with suicidal ideation at baseline is presented below for categories with at least 1 participant. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Event (TEAEs) | Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow up after the last dose) | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Intensity of Treatment Emergent Adverse Events | Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow-up after the last dose) | Safety Set; event-based analysis | Number of TEAEs | NUMBER |
| SECONDARY | Changes From Baseline in the Average Pain Intensity in the Last Week During the Treatment Period | Baseline Visit (Day 1) to End of Treatment Visit (up to 26 weeks). | Safety Set - participants with data available | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Outcome of Treatment Emergent Adverse Events (TEAE) | Baseline (Day 2) to End of trial (i.e., up to Week 28) | Safety Set; event-based analysis | Number of TEAEs | NUMBER |
| OTHER_PRE_SPECIFIED | Time to Onset of Treatment Emergent Adverse Events (TEAEs) | Baseline (Day 2) to End of trial (up to Week 28) | Safety Set; event-based analysis for 661 TEAEs. | days | MEDIAN |
| OTHER_PRE_SPECIFIED | Duration of Treatment Emergent Adverse Events (TEAEs) | Baseline (Day 2) to End of trial (up to Week 28) | Safety Set; data available for 373 TEAEs (duration data for 288 of 661 TEAEs were not available) | days | MEDIAN |
| OTHER_PRE_SPECIFIED | Causal Relationship of Treatment Emergent Adverse Events (TEAEs) | Baseline (Day 2) to End of trial (up to Week 28) | Safety Set; event-based analysis on 661 TEAEs | Number of TEAEs | NUMBER |
| OTHER_PRE_SPECIFIED | Countermeasures Taken for Treatment Emergent Adverse Events (TEAEs) | Baseline (Day 2) to End of trial (up to Week 28) | Safety Set; event-based analysis. | Number of TEAEs | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Related to Cebranopadol | Baseline (Day 2) to End of trial (up to Week 28) | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Columbia-Suicide Severity Rating Scale (C-SSRS) Scores | Baseline (Day 1) to End of trial (up to Week 28) | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group104
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Event (TEAEs) | Cebranopadol | 64 | Participants | ||
| Intensity of Treatment Emergent Adverse Events | Cebranopadol | Mild intensity | 242 | Number of TEAEs | |
| Intensity of Treatment Emergent Adverse Events | Cebranopadol | Moderate intensity | 300 | Number of TEAEs | |
| Intensity of Treatment Emergent Adverse Events | Cebranopadol | Severe intensity | 119 | Number of TEAEs | |
| Changes From Baseline in the Average Pain Intensity in the Last Week During the Treatment Period | Cebranopadol | 0.8 | Standard Deviation 2.14 | units on a scale | |
| Outcome of Treatment Emergent Adverse Events (TEAE) | Cebranopadol | Recovered/resolved | 349 | Number of TEAEs | |
| Outcome of Treatment Emergent Adverse Events (TEAE) | Cebranopadol | Recovered/resolved with sequelae | 11 | Number of TEAEs | |
| Outcome of Treatment Emergent Adverse Events (TEAE) | Cebranopadol | Not recovered/not resolved | 260 | Number of TEAEs | |
| Outcome of Treatment Emergent Adverse Events (TEAE) | Cebranopadol | Recovering/resolving | 14 | Number of TEAEs | |
| Outcome of Treatment Emergent Adverse Events (TEAE) | Cebranopadol | Fatal | 11 | Number of TEAEs |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cebranopadol | 76 | |
| Overall Study | Completing the Titration Phase | Cebranopadol | 67 | |
| Overall Study | Completing the Treatment | Cebranopadol | 39 | |
| Overall Study | COMPLETED | Cebranopadol | 38 | |
| Overall Study | NOT COMPLETED | Cebranopadol | 38 |
Source ClinicalTrials.gov
Adverse events69
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 | Gamma-glutamyltransferase increased | Investigations | Cebranopadol | 4 | 76 | 4 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | Cebranopadol | 7 | 76 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Cebranopadol | 6 | 76 | 7 |
| other | Leukocytosis | Blood and lymphatic system disorders | Cebranopadol | 5 | 76 | 5 |
| other | Leukopenia | Blood and lymphatic system disorders | Cebranopadol | 6 | 76 | 7 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cebranopadol | 6 | 76 | 6 |
| other | Thrombocytosis | Blood and lymphatic system disorders | Cebranopadol | 7 | 76 | 10 |
| other | Headache | Nervous system disorders | Cebranopadol | 8 | 76 | 8 |
| other | Somnolence | Nervous system disorders | Cebranopadol | 8 | 76 | 9 |
| other | Dizziness | Nervous system disorders | Cebranopadol | 5 | 76 | 6 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cebranopadol | 10 | 76 |
| Total, other adverse events | Cebranopadol | 63 | 76 |
| Total, serious adverse events | Cebranopadol | 32 | 76 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31152783 | RESULT |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02031432
GET https://conductscience.org/api/trials/v1/NCT02031432/registered?page=2