Clinical Trial comparing the ability of pain reduction and side effects of a new anti-pain medicament Cebranopadol and morphine sulfate Prolonged Release (PR) in patients suffering from chronic cancer pain of moderate to severe strength.
- Conditions
- 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.MedDRA version: 17.0Level: PTClassification code 10058019Term: Cancer painSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2012-001316-35-AT
- Lead Sponsor
- Grünenthal GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 625
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 <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
non-childbearing potential may be included if post-menopausal for at least 2 years and =55 years 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 <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 with their current pain treatment.
• Suffering from cancer-related but not cancer therapy-related chronic pain for a period of =4 weeks prior to Visit 1.
5. Performance Status: Eastern Cooperation Oncology Group (ECOG) =2.
Additional inclusion criteria at Visit 2
6. Subjects with a mean score of =5 points (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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 363
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 262
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 <2000/µL, a platelet count =100 000/µL, and a hemoglobin level <8 g/dL at the Enrollment Visit (Visit 1).
10. Subjects with impaired renal function. Creatinine clearance less than 60 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 (see Concomitant medications/therapies).
12. Uncontrolled hypertension (repeated measurements of systolic blood pressure >160 mmHg or diastolic blood pressure >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 (>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.
19. Previous participation in this or other trials with cebranopadol.
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method