PainPhase 3CORAL XTNCT02031432
CORAL XT - Open-label Extension Trial of the CORAL Trial
A Phase 3 study testing Cebranopadol in people with Pain and Neoplasms, run by Tris Pharma, Inc. at 22 sites in 10 countries.
Trial summary
The purpose of this trial was to find out how well cebranopadol is tolerated and how often, and which, adverse reactions occur when it is taken every day for a longer period of time. In addition, information was collected how cebranopadol affects pain and well-being in patients suffering from cancer-related pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Neoplasms, Chronic Pain
- What is being tested?
- Cebranopadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 22 sitesin 10 countries
- Study dates
- 18 Dec 2013to 3 May 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent signed indicating that the participant understands the purpose of and procedures required for the trial and is willing to participate in the trial.
- Participants must be at least 18 years of age at the Enrollment Visit.
- Women of childbearing potential must have a negative pregnancy test at enrollment and must not be lactating at the Enrollment Visit.
- Participants must be willing to use medically acceptable and highly effective methods of birth control.
- Participants who have completed treatment in KF6005/07 and are still in need of around-the-clock pain analgesia with strong opioids.
Who cannot join
- The participant has a clinically significant disease or condition other than cancer which in the investigator's opinion may affect efficacy or safety assessments.
- Known to or suspected of not being able to comply with the protocol and the use of cebranopadol.
- Participants taking forbidden concomitant medications or not being able to follow the rules of use of concomitant treatment.
- History of torsade de pointes and/or presence of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, bradycardia).
- Concurrent participation in another trial (except participation in KF6005/07) or planning to be enrolled in another clinical trial (i.e., administration of experimental treatment in another clinical trial) during the course of this trial, or previous participation in this trial.
- Employees of the sponsor, investigator, or trial site or family members of the employees, sponsor, or investigator.
Trial locations and contacts
22 sites in 10 countries.
22 sites in 10 countries
Bulgaria4 sites
BG001
Shumen, 9700
BG008
Sofia, 1330
BG003
Sofia, 1407
BG004
Sofia, 1407
Poland4 sites
PL012
Będzin, 42-500
PL014
Dąbrowa Górnicza, 41-300
PL003
Gdansk, 80-208
PL010
Gliwice, 44-100
Slovakia3 sites
SK004
Bratislava, 851 07
SK001
Prešov, 08001
SK005
Pruské, 018 52
About this study
Official title: An Open-label, Multi-site Trial to Describe the Safety and Tolerability of Oral Cebranopadol Administered for 26 Weeks in Subjects With Cancer-related Pain Who Have Completed Treatment in the KF6005/07 Trial
The purpose of this trial was to find out how well cebranopadol is tolerated and how often, and which, adverse reactions occur when it is taken every day for a longer period of time. In addition, information was collected how cebranopadol affects pain and well-being in patients suffering from cancer-related pain.
Read the detailed description
The trial consisted of 3 phases: Titration Phase, Maintenance Phase, and Follow-Up. The total duration of the trial was approximately 28 weeks for each individual participant, including the Follow-up. The participants received cebranopadol for a maximum of approximately 26 weeks.
- Conditions
- Pain, Neoplasms, Chronic Pain
- Being tested
- Cebranopadol
- Keywords
- cancer-related pain, cebranopadol
- Medical subject headings
- Pain, Neoplasms, Chronic Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CebranopadolDrug
Also called GRT6005
Film-coated tablet; strengths: 200, 400, or 600 µg
| Study group | Role | What they receive |
|---|---|---|
| Cebranopadol | Experimental | Cebranopadol 200 µg to 1000 µg per taken taken once a day in the morning.
Allowed dose levels in the Maintenance Phase were 200, 400, 600, 800, or 1000 µg per day. Receives: Drug: Cebranopadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Event (TEAEs)
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.
Measured: Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow up after the last dose)
Secondary outcomes (2)
Intensity of Treatment Emergent Adverse Events
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.
Measured: Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow-up after the last dose)
Changes From Baseline in the Average Pain Intensity in the Last Week During the Treatment Period
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.
Measured: Baseline Visit (Day 1) to End of Treatment Visit (up to 26 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study start18 Dec 2013
- Primary completionApr 2016
- Study completion3 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director Clinical Trials, Study director, Grünenthal GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031432
- Sponsor's protocol ID
- KF6005/09
- Other IDs
- 2013-001877-26, U1111-1144-0778
- Acronym
- CORAL XT
- Status last verified
- Jul 2021
- First submitted
- 12 Dec 2013
- Last updated
- 15 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koch ED, Kapanadze S, Eerdekens MH, Kralidis G, Letal J, Sabatschus I, Ahmedzai SH. Cebranopadol, a Novel First-in-Class Analgesic Drug Candidate: First Experience With Cancer-Related Pain for up to 26 Weeks. J Pain Symptom Manage. 2019 Sep;58(3):390-399. doi: 10.1016/j.jpainsymman.2019.05.012. Epub 2019 May 30.
PubMed 31152783
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-site Trial to Describe the Safety and Tolerability of Oral Cebranopadol Administered for 26 Weeks in Subjects With Cancer-related Pain Who Have Completed Treatment in the KF6005/07 Trial
- ClinicalTrials.gov ID
- NCT02031432
- Acronym / sponsor ID
- CORAL XT / KF6005/09
- Conditions
- Pain, Neoplasms, Chronic Pain
- Keywords
- cancer-related pain, cebranopadol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2013 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- 3 May 2016 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial was to find out how well cebranopadol is tolerated and how often, and which, adverse reactions occur when it is taken every day for a longer period of time. In addition, information was collected how cebranopadol affects pain and well-being in patients suffering from cancer-related pain.
Detailed description
The trial consisted of 3 phases: Titration Phase, Maintenance Phase, and Follow-Up. The total duration of the trial was approximately 28 weeks for each individual participant, including the Follow-up. The participants received cebranopadol for a maximum of approximately 26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cebranopadol | Experimental | Drug: CebranopadolCebranopadol 200 µg to 1000 µg per taken taken once a day in the morning. Allowed dose levels in the Maintenance Phase were 200, 400, 600, 800, or 1000 µg per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent signed indicating that the participant understands the purpose of and procedures required for the trial and is willing to participate in the trial.
- Participants must be at least 18 years of age at the Enrollment Visit.
- Women of childbearing potential must have a negative pregnancy test at enrollment and must not be lactating at the Enrollment Visit.
- Participants must be willing to use medically acceptable and highly effective methods of birth control.
- Participants who have completed treatment in KF6005/07 and are still in need of around-the-clock pain analgesia with strong opioids.
Key exclusion criteria (6 listed)
- The participant has a clinically significant disease or condition other than cancer which in the investigator's opinion may affect efficacy or safety assessments.
- Known to or suspected of not being able to comply with the protocol and the use of cebranopadol.
- Participants taking forbidden concomitant medications or not being able to follow the rules of use of concomitant treatment.
- History of torsade de pointes and/or presence of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, bradycardia).
- Concurrent participation in another trial (except participation in KF6005/07) or planning to be enrolled in another clinical trial (i.e., administration of experimental treatment in another clinical trial) during the course of this trial, or previous participation in this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CebranopadolAlso: GRT6005Film-coated tablet; strengths: 200, 400, or 600 µg | Drug | Cebranopadol |
Primary outcome
Number of Participants With Treatment Emergent Adverse Event (TEAEs)
Time frame: 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.
2 secondary outcomes
Intensity of Treatment Emergent Adverse Events
Time frame: Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow-up after the last dose)
Changes From Baseline in the Average Pain Intensity in the Last Week During the Treatment Period
Time frame: Baseline Visit (Day 1) to End of Treatment Visit (up to 26 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31152783Koch ED, Kapanadze S, Eerdekens MH, Kralidis G, Letal J, Sabatschus I, Ahmedzai SH. Cebranopadol, a Novel First-in-Class Analgesic Drug Candidate: First Experience With Cancer-Related Pain for up to 26 Weeks. J Pain Symptom Manage. 2019 Sep;58(3):390-399. doi: 10.1016/j.jpainsymman.2019.05.012. Epub 2019 May 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Director Clinical Trials study director
Grünenthal GmbH
22 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cebranopadol in people with Pain and Neoplasms, run by Tris Pharma, Inc. at 22 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Bulgaria, Poland, Serbia, Slovakia, Denmark and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Event (TEAEs) (time frame: Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow up after the last dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02031432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.