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    Summary
    EudraCT Number:2012-001316-35
    Sponsor's Protocol Code Number:KF6005/07
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-30
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2012-001316-35
    A.3Full title of the trial
    Efficacy, safety, and tolerability of oral Cebranopadol versus morphine sulphate PR in subjects with chronic moderate to severe pain related to cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CORAL – Cebranopadol versus morphine prolonged-release in patients with chronic moderate to severe pain related to cancer
    A.3.2Name or abbreviated title of the trial where available
    CORAL
    A.4.1Sponsor's protocol code numberKF6005/07
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01964378
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1143-1808
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGrünenthal GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGrünenthal GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrünenthal GmbH
    B.5.2Functional name of contact pointGRT Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressZieglerstr. 6
    B.5.3.2Town/ cityAachen
    B.5.3.3Post code52078
    B.5.3.4CountryGermany
    B.5.4Telephone number+492415693223
    B.5.6E-mailclinical-trials@grunenthal.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCebranopadol 200 µg film-coated tablet
    D.3.2Product code GRT6005
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCebranopadol
    D.3.9.2Current sponsor codeGRT6005
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCebranopadol 400 µg film-coated tablet
    D.3.2Product code GRT6005
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCebranopadol
    D.3.9.2Current sponsor codeGRT6005
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCebranopadol 600 µg film-coated tablet
    D.3.2Product code GRT6005
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCebranopadol
    D.3.9.2Current sponsor codeGRT6005
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name MST Continus 15 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNapp Pharmaceuticals Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmorphine sulphate
    D.3.9.1CAS number 6211-15-0
    D.3.9.3Other descriptive nameMORPHINE SULFATE PENTAHYDRATE
    D.3.9.4EV Substance CodeSUB22187
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name MST Continus 30 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNapp Pharmaceuticals Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmorphine sulphate
    D.3.9.1CAS number 6211-15-0
    D.3.9.3Other descriptive nameMORPHINE SULFATE PENTAHYDRATE
    D.3.9.4EV Substance CodeSUB22187
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The trial population, comprising patients with cancer pain requiring WHO Step III analgesics, will represent the typical population suffering from cancer-related pain. Patient having various types of cancer will be included. The pain condition affecting cancer patients represents a mixed type of pain as it is composed of various pain components (i.e., visceral, neuropathic, and somatic) of different dominance depending on the type of cancer, its stage, localization, and previous treatments.
    E.1.1.1Medical condition in easily understood language
    In this clinical trial patients with chronic, cancer related pain will be recruited. Chronic pain is among the most important of symptoms associated with the course of cancer disease.
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10058019
    E.1.2Term Cancer pain
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the efficacy of orally administered Cebranopadol in comparison with morphine sulfate PR in subjects suffering from chronic moderate to severe pain related to cancer.
    E.2.2Secondary objectives of the trial
    The secondary objective is to compare the safety and tolerability of Cebranopadol and morphine sulfate PR.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must have signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial.
    2. Subjects must be at least 18 years of age at the Enrollment Visit (Visit 1).
    3. Women of childbearing potential must have a negative pregnancy test at Visit 1 and Visit 2 and must not be lactating at Visit 1. Subjects must
    be willing to use medically acceptable and highly effective methods of birth control. For women of childbearing potential a medically acceptable
    and highly effective method of birth control is defined as any form of contraception with a low failure rate defined as less than 1% per year.
    For example:
    • Hormonal contraceptives for at least 2 months prior to the Enrollment Visit (Visit 1) and until at least 4 weeks after the End of Treatment Visit
    (Visit 11).
    • An intra-uterine device. Additional barrier contraception must be used by the partner for the duration of the trial, defined as from the time of the Enrollment Visit until 4 weeks after the End of Treatment Visit. Women of nonchildbearing potential may be included if post-menopausal for at least 2
    years and 55 years or more old.
    For men:
    Men have to use barrier contraception (condom) during sexual intercourse from the first administration of IMP until 4 weeks after the End of Treatment Visit. The male subject has to take care that the female sexual partner uses at least 1 additional method of contraception with a low failure rate defined as less than 1% per year (e.g., oral contraceptives) during this time frame. A double-barrier method should be supplemented by the use of spermicidal agents.
    4. Subjects fulfilling the following 4 criteria:
    • Requiring daily basic pain analgesia diagnosed with active cancer including hematological malignant diseases.
    • Receiving daily opioid treatment at doses not higher than 90 mg oral morphine or its equivalent (including World Health Organization [WHO]
    Step II and Step III analgesics) for an appropriate length of time.
    • Dissatisfied (due to lack of efficacy or poor tolerability) with their current pain treatment.
    • Suffering from cancer-related but not cancer therapy-related chronic pain for a period of greater or equal to 4 weeks prior to Visit 1.
    5. Performance Status: Eastern Cooperation Oncology Group (ECOG) less than or equal to 2.
    Additional inclusion criteria at Visit 2
    6. Subjects with a mean score of 5 points or more (11-point NRS) for the "average pain intensity over the last 24 hours" calculated from the pain
    assessments recorded during the last 3 days prior to Visit 2.
    7. Compliance with the use of the e-diary defined as at least 3 out of 4 of the 24 hour NRS entries available during the last 4 days prior to and
    including the day of Visit 2.

    E.4Principal exclusion criteria
    1. Evidence of ongoing alcohol/drug abuse or history of alcohol/drug abuse within the last 2 years in the investigator's judgment, based on patient history and physical examination.
    2. The subject has a clinically significant disease other than cancer which in the investigator's opinion may affect efficacy or safety assessments
    e.g., significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, infectious disease, psychiatric (resulting in
    disorientation, memory impairment or inability to report accurately) or metabolic disorders.
    3. Subjects with any gastrointestinal disorder that could, in the investigator's opinion, affect the absorption and/or elimination of IMP.
    4. Any pre-scheduled major surgery during the trial.
    5. Known to or suspected of not being able to comply with the trial protocol and the use of IMP.
    6. History of seizure disorder and/or epilepsy or any condition associated with a significant risk of seizure or epilepsy.
    7. Known history and/or presence of symptomatic cerebral tumor or cerebral metastases.
    8. Subjects with moderate to severe hepatic impairment corresponding to Child-Pugh classification B and C. Subjects with impaired hepatic
    cellular integrity indicated by aspartate transaminase (AST) or alanine transaminase (ALT) greater than 3 times the upper limit of normal (ULN)
    at the Enrollment Visit (Visit 1).
    9. Inadequate baseline bone marrow reserve with a white blood cell count less than 2000/μL, a platelet count less than or equal to 100
    000/μL, and a hemoglobin level less than 8 g/dL at the Enrollment Visit (Visit 1).
    10. Subjects with impaired renal function. Creatinine clearance less than 45 mL per minute at the Enrollment Visit (Visit 1) (calculated from the
    Cockcroft-Gault formula).
    11. Subjects taking any forbidden concomitant medications or not being able to follow the rules of use of prior and concomitant treatment.
    12. Uncontrolled hypertension (repeated measurements of systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater
    than 95 mmHg).
    13. Clinically relevant history of hypersensitivity, allergy or contraindications to opioid medication or any of the excipients of morphine sulfate (PR or IR), or cebranopadol film-coated tablets.
    14. Chronic hepatitis B or C, or human immunodeficiency virus (HIV) known by history, or presence of active hepatitis B or C within the 3 months before the Enrollment Visit.
    15. History of torsade de pointes and/or presence of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, or bradycardia).
    16. Marked prolongation of QTcF (greater than 450 ms) at the Enrollment Visit (Visit 1) confirmed by repeated measurement.
    17. Employees of the sponsor, investigator, or trial site or family members of the employees, sponsor, or investigator.
    18. Concurrent participation in another trial 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(does not include observational studies).
    19. Previous participation in this or other trials with cebranopadol with the following exceptions:
    • Subjects who failed enrollment in this trial only because of exclusion criterion 10, which was changed in Amendment 04, and who may now be eligible can be re-enrolled.
    • Subjects who failed enrollment due to technical failure of equipment (e.g., ECG machine and e-diary device).
    20. Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.
    21. Currently not receiving opioid treatment for cancer-related pain (i.e.,opioid naïve).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the average amount of daily rescue medication intake over the last 2 weeks of the Maintenance Phase.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Last 2 weeks of the Maintenance Phase
    E.5.2Secondary end point(s)
    The secondary efficacy endpoint is the proportion of subjects with
    clinically relevant pain reduction over the last 2 weeks of the
    Maintenance Phase.
    The secondary safety endpoint is the frequency of treatment emergent
    adverse events (TEAEs).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy endpoint - Last 2 weeks of the Maintenance Phase.
    Secondary safety endpoint - up to 44 days of planned treatment.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    double-dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    morphine prolonged release
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA90
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Austria
    Belgium
    Brazil
    Bulgaria
    Chile
    Croatia
    Denmark
    France
    Germany
    Hungary
    Mexico
    Netherlands
    Peru
    Poland
    Romania
    Serbia
    Slovakia
    Spain
    Sweden
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 363
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 262
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 308
    F.4.2.2In the whole clinical trial 655
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Some subjects may be offered the opportunity to continue with cebranopadol open label treatment at the end of the trial in the KF6005/09 long-term follow up trial. Subjects opting not to continue in the KF6005/09 trial will not receive investigational medicinal product (IMP) but will receive the standard of care at the site.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-16
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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