Efficacy, safety, and tolerability of oral cebranopadol versus morphine sulfate PR in subjects with chronic moderate to severe pain related to cancer.
- Conditions
- Pijn bij kankerpain related to cancer
- Registration Number
- NL-OMON41472
- Lead Sponsor
- Grunenthal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 25
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 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 (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 *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.
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 cerebral tumor or cerebral metastases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the average amount of daily rescue medication intake<br /><br>over the last 2 weeks of the Maintenance Phase.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary efficacy endpoint is the proportion of subjects with clinically<br /><br>relevant pain reduction over the last 2 weeks of the Maintenance Phase.<br /><br><br /><br>Definition of clinically relevant pain reduction:<br /><br>* Average pain intensity of <4 points on the 11-point NRS<br /><br>Or<br /><br>* Reduction in average pain intensity by *30% (compared to the baseline<br /><br>assessment)<br /><br>Or<br /><br>* Reduction in average pain intensity by *2 points (compared to the baseline<br /><br>assessment)<br /><br>(The average pain intensity is the average of the 24-hour pain intensities over<br /><br>the last 2 weeks of the Maintenance Phase)<br /><br><br /><br>The secondary safety endpoint is the frequency of treatment emergent adverse<br /><br>events (TEAEs).</p><br>