Trial · NCT01964378
CORAL - Cebranopadol Versus Morphine Prolonged-release in Patients With Chronic Moderate to Severe Pain Related to Cancer
NCT01964378, Phase 3, Terminated, Tris Pharma, Inc.; results first posted 2019-12-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CORAL - Cebranopadol Versus Morphine Prolonged-release in Patients With Chronic Moderate to Severe Pain Related to Cancer. Trials, record NCT01964378. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01964378
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CORAL - Cebranopadol Versus Morphine Prolonged-release in Patients With Chronic Moderate to Severe Pain Related to Cancer
- NCT number
- NCT01964378
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 200 participants, actual
- Lead sponsor
- Tris Pharma, Inc.
- Conditions
- Pain, Neoplasms, Chronic Pain
- Interventions
- Cebranopadol, Morphine Prolonged Release
- First posted
- 2013-10-17
- Last updated
- 2021-07-15
- Other registries' IDs
- eudract:2012-001316-35
- Results first posted
- 2019-12-30
- Limitations and caveats
As the enrollment was stopped for business reasons, only a fraction of the planned number of participants was enrolled; however, the trial still has a larger participant number per treatment than a majority of trials in cancer pain so far.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Amount of Daily Rescue Medication at the End of the Maintenance Period (Per Protocol Set) | The last 2 weeks of the expected 6-week treatment period. | Morphine sulfate immediate release (IR) 10 mg tablets were supplied as rescue medication to trial participants. No dose adjustments of the morphine prolonged release or cebranopadol were allowed during the maintenance period. The daily use of morphine sulfate 10 mg IR tablets was documented by each participant in the trial. The total daily amount of morphine IR was subject to an upper limit recommendation. The primary endpoint is the average amount of daily rescue medication intake over the last 2 weeks of the maintenance period. |
| Primary | Average Amount of Daily Rescue Medication at the End of the Maintenance Period (Full Analysis Set) | The last 2 weeks of the expected 6-week treatment period. | Morphine sulfate IR 10 mg tablets were supplied as rescue medication to trial participants. No dose adjustments of the morphine prolonged release or cebranopadol were allowed during the maintenance period. The daily use of morphine sulfate 10 mg IR tablets was documented by each participant in the trial. The total daily amount of morphine IR was subject to an upper limit recommendation. The primary endpoint is the average amount of daily rescue medication intake over the last 2 weeks of the maintenance period. |
| Secondary | Proportion of Participants With Clinically Relevant Pain Reduction at the End of the Maintenance Period | The last 2 weeks of the expected 6-week treatment period. | Each participant indicated the level of pain 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 participants entered their pain intensity in their diary on a daily basis. The pain intensity score in the 2 weeks prior to the final evaluation in the maintenance period was compared with the baseline, the baseline pain intensity was calculated based on the 3 days prior to treatment allocation. The definition of a clinically relevant pain reduction (yes/no) was the presence of at least 1 of the 3 following conditions: * Average pain intensity (i.e., average of the 24-hour pain intensities over the last 2 weeks of the Maintenance Phase) of less than 4 points on the 11-point NRS, or * Reduction in average pain intensity by at least 30% (compared to the baseline assessment), or * Reduction in average pain intensity by at least 2 points (compared to the baseline assessment). |
| Other | Change in Weekly Mean of the Daily Average Pain Intensity Score From Baseline | Baseline; last 2 weeks of the expected 6-week treatment period | Participants will be asked: "Please rate your pain by selecting the one number that best describes your pain on average during the last 24 hours." every day in the morning. They will score their pain intensity 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 weekly mean value of the 24-h average pain intensity will be calculated as a mean score of these daily entries of average pain intensity for each trial week. |
| Other | Response Rate to Treatment | Baseline; last 2 weeks of the expected 6-week treatment period | Pain intensity will be recorded daily by each participant in the morning on an 11-point Numerical Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain). From this, the weekly average 24-hour pain intensity will be calculated. The number of participants with a 0, 10, 20, 30, up to a 100% reduction in weekly mean pain intensity will be reported over each week and over the last 2 weeks of the maintenance period. |
| Other | Overall Score of the Neuropathic Pain Symptom Inventory (NPSI) | Baseline; End-of-Treatment Visit (Week 6) | Participants with neuropathic pain (determined by the completion of the Douleur Neuropathique En 4 Questions \[DN4\] questionnaire at allocation) rated their symptoms of neuropathic pain on the Neuropathic Pain Symptom Inventory (NPSI). Ten out of 12 questions were answered on an 11-point scale 0 (no symptom present) to 10 (worst imaginable); 2 out of 12 questions assessed the duration of spontaneous pain and the number of pain attacks and were answered by selecting 1 of 5 possible responses. Mean scores of NPSI were calculated. The overall NPSI score was calculated by the summation of all responses in the ranges between 0 (all symptoms absent) and 1 (all symptoms present and at the worst intensity). A negative change indicates that the intensity of all the neuropathic symptom components have decreased since the start of treatment. |
| Other | EuroQol-5 Dimension (EQ-5D) Health Questionnaire: Weighted EQ-5D Health Status Index | Baseline; End-of-Treatment Visit (6 weeks) | The EuroQol-5 Dimension Health Questionnaire is a generic health related quality of life instrument. The participants will answer 5 questions on 5 dimensions of their health related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question has 3 possible answers reflecting 3 levels of impact on the quality of life. The weighted EQ-5D health status index values are derived and reported as change from baseline. The responses to the 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score (with 1 indicating "full health" and 0 representing "dead"). The higher the values (the closer the value is to 1) the better the health status in a treatment group. A positive change indicates an improvement. |
| Other | EuroQol-5 Dimension (EQ-5D) Health Questionnaire: Visual Analog Scale (VAS) Score | Baseline; End-of-Treatment Visit (6 weeks) | The EuroQol-5 Dimension Health Questionnaire is a generic health related quality of life instrument. EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement. |
| Other | Change in the Physical and Mental Component Scores From the Short Form 12® Health Survey (SF-12) | Baseline; End-of-Treatment Visit (6 weeks) | The Physical and Mental Component Scores are calculated from the responses by participants to 12 questions. These 12 questions cover 8 domains, (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role participation with emotional health problems, and mental health) that a participant was asked to rate over the last week. Questions are scored on a Likert-scale. The Physical and Mental Component Scores were not derived as the trial was terminated. Changes in the individual item scores are therefore reported. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state. If the values are positive there was an improvement. The higher the value the greater the improvement. |
| Other | Patient Global Impression of Change (PGIC) | Baseline; End-of-Treatment Visit (6 weeks) | In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period compared to his condition prior to the start of treatment. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Amount of Daily Rescue Medication at the End of the Maintenance Period (Per Protocol Set) | The last 2 weeks of the expected 6-week treatment period. | The Per Protocol Set (PPS) describes a subset of subjects in the Full Analysis Set (FAS). The PPS included all allocated participants who completed at least 2 weeks of treatment in the maintenance phase and had no major protocol deviations relevant for efficacy evaluations. | milligram(s)/24 hours | LEAST_SQUARES_MEAN |
| PRIMARY | Average Amount of Daily Rescue Medication at the End of the Maintenance Period (Full Analysis Set) | The last 2 weeks of the expected 6-week treatment period. | The Full Analysis Set includes all allocated participants who took at least 1 dose of the investigational medicinal product (IMP) and had at least 1 day with information for the amount of rescue medication intake after the first intake of double-blind IMP (study drug). | milligram(s)/24 hours | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Participants With Clinically Relevant Pain Reduction at the End of the Maintenance Period | The last 2 weeks of the expected 6-week treatment period. | Full Analysis Set (FAS). Clinically relevant pain reduction (Yes/No) in Maintenance Week 3 and Week 4. Missing data were imputed using a multiple imputation on the weekly average pain intensity. Participants that discontinued from the trial due to a lack of efficacy were classified as non-responders. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change in Weekly Mean of the Daily Average Pain Intensity Score From Baseline | Baseline; last 2 weeks of the expected 6-week treatment period | Full Analysis Set (FAS) | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Response Rate to Treatment | Baseline; last 2 weeks of the expected 6-week treatment period | Full Analysis Set (FAS). Worsening in 24-hour pain or premature discontinuation due to lack of efficacy or Adverse Event was regarded a non-response, other missing data is imputed using last observation carried forward (LOCF). | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Overall Score of the Neuropathic Pain Symptom Inventory (NPSI) | Baseline; End-of-Treatment Visit (Week 6) | Subset of participants that were assessed to have Neuropathic Pain (using the DN4 questionnaire) at baseline. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | EuroQol-5 Dimension (EQ-5D) Health Questionnaire: Weighted EQ-5D Health Status Index | Baseline; End-of-Treatment Visit (6 weeks) | Full Analysis Set; means (standard deviations) are presented for the number of participants at the End-of-Treatment Visit with respective data available. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | EuroQol-5 Dimension (EQ-5D) Health Questionnaire: Visual Analog Scale (VAS) Score | Baseline; End-of-Treatment Visit (6 weeks) | Full Analysis Set; means (standard deviations) are presented for the number of participants at the End-of-Treatment Visit with respective data available. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change in the Physical and Mental Component Scores From the Short Form 12® Health Survey (SF-12) | Baseline; End-of-Treatment Visit (6 weeks) | Full Analysis Set (FAS). End of Treatment (End of Maintenance Period Visit). | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Patient Global Impression of Change (PGIC) | Baseline; End-of-Treatment Visit (6 weeks) | Full Analysis Set (FAS). End of Treatment (End of Maintenance Period Visit). Participants with data available. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Amount of Daily Rescue Medication at the End of the Maintenance Period (Per Protocol Set) | Cebranopadol | 4.25 | Standard Error 1.7 | milligram(s)/24 hours | |
| Average Amount of Daily Rescue Medication at the End of the Maintenance Period (Per Protocol Set) | Morphine Prolonged Release | 8.92 | Standard Error 1.72 | milligram(s)/24 hours | |
| Average Amount of Daily Rescue Medication at the End of the Maintenance Period (Full Analysis Set) | Cebranopadol | 3.46 | Standard Error 1.71 | milligram(s)/24 hours | |
| Average Amount of Daily Rescue Medication at the End of the Maintenance Period (Full Analysis Set) | Morphine Prolonged Release | 10.94 | Standard Error 1.75 | milligram(s)/24 hours | |
| Proportion of Participants With Clinically Relevant Pain Reduction at the End of the Maintenance Period | Cebranopadol | Clinically relevant pain reduction (Yes) | 48 | Participants | |
| Proportion of Participants With Clinically Relevant Pain Reduction at the End of the Maintenance Period | Morphine Prolonged Release | Clinically relevant pain reduction (Yes) | 51 | Participants | |
| Proportion of Participants With Clinically Relevant Pain Reduction at the End of the Maintenance Period | Cebranopadol | Clinically relevant pain reduction (No) | 16 | Participants | |
| Proportion of Participants With Clinically Relevant Pain Reduction at the End of the Maintenance Period | Morphine Prolonged Release | Clinically relevant pain reduction (No) | 10 | Participants | |
| Change in Weekly Mean of the Daily Average Pain Intensity Score From Baseline | Cebranopadol | -3.4 | Standard Deviation 2.11 | units on a scale | |
| Change in Weekly Mean of the Daily Average Pain Intensity Score From Baseline | Morphine Prolonged Release | -3.2 | Standard Deviation 1.60 | units on a scale |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cebranopadol | 66 | |
| Overall Study | STARTED | Morphine Prolonged Release | 66 | |
| Overall Study | Participants Treated (Safety Set) | Cebranopadol | 65 | |
| Overall Study | Participants Treated (Safety Set) | Morphine Prolonged Release | 61 | |
| Overall Study | COMPLETED | Cebranopadol | 41 | |
| Overall Study | COMPLETED | Morphine Prolonged Release | 45 | |
| Overall Study | NOT COMPLETED | Cebranopadol | 25 | |
| Overall Study | NOT COMPLETED | Morphine Prolonged Release | 21 |
Source ClinicalTrials.gov
Adverse events72
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 | Anaemia | Blood and lymphatic system disorders | Cebranopadol | 3 | 65 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Morphine Prolonged Release | 5 | 61 | 5 |
| other | Somnolence | Nervous system disorders | Cebranopadol | 6 | 65 | 7 |
| other | Somnolence | Nervous system disorders | Morphine Prolonged Release | 5 | 61 | 5 |
| other | Paraesthesia | Nervous system disorders | Cebranopadol | 4 | 65 | 4 |
| other | Paraesthesia | Nervous system disorders | Morphine Prolonged Release | 1 | 61 | 1 |
| other | Dizziness | Nervous system disorders | Cebranopadol | 2 | 65 | 2 |
| other | Dizziness | Nervous system disorders | Morphine Prolonged Release | 6 | 61 | 6 |
| other | Vertigo | Ear and labyrinth disorders | Cebranopadol | 2 | 65 | 2 |
| other | Vertigo | Ear and labyrinth disorders | Morphine Prolonged Release | 4 | 61 | 4 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cebranopadol | 3 | 66 |
| Total, all-cause mortality | Morphine Prolonged Release | 5 | 66 |
| Total, other adverse events | Cebranopadol | 52 | 65 |
| Total, other adverse events | Morphine Prolonged Release | 48 | 61 |
| Total, serious adverse events | Cebranopadol | 14 | 65 |
| Total, serious adverse events | Morphine Prolonged Release | 11 | 61 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30365202 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cebranopadol vs Morphine Prolonged Release: deaths from any cause | Trial comparisons |
| Cebranopadol vs Morphine Prolonged Release: serious adverse events | 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.
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