| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Chronic cancer pain |
| Chronická malígna bolesť |
|
| E.1.1.1 | Medical condition in easily understood language |
| Chronic pain associated with malignant diseases |
| Chronická bolesť spojená s malígnymi ochoreniami |
|
| E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10058019 |
| E.1.2 | Term | Cancer pain |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| The primary objective of this study is to compare the consumption (mg) of rescue analgesia (immediate release morphine sulfate tablets) per day after the administration of sufentanil TDS to its consumption after the administration of SR morphine sulfate (during the maintenance period (Visit 9 to 13)). |
| Primárnym cieľom tejto štúdie je porovnanie dennej spotreby (mg) záchrannej liečby (tablety morfín-sulfátu s rýchlym uvoľňovaním) pri podávaní sufentanilu TDS so jeho spotrebou pri podávani SR morfín-sulfátu (počas udržiavacieho obdobia (Návšteva 9 až 13)). |
|
| E.2.2 | Secondary objectives of the trial |
The secondary efficacy objectives of this study are to evaluate:
• Rescue analgesic use (doses/day and time of day)
• Pain intensity (0-10 numerical scale)
• Incidence and time (days) to withdrawal due to lack of efficacy
• Sedation (0-10 numerical scale)
• Nausea (0-10 numerical scale)
• Constipation (0-10 numerical scale)
• Investigators and patient’s global assessment of response to therapy
• Quality of life assessment (EORTC)
The secondary safety objectives of this study are to evaluate:
• adverse events
• local tolerance
• vital signs
• clinical laboratory evaluations
• 12-lead ECG
|
Sekundárnymi cielmi účinnosti tejto štúdie sú:
• Použitie záchrannej analgézie (dávky/deň a denná doba)
• Intenzita bolesti (0-10 číselná škála)
• Incidencia a čas (dni) po odstúpenie pre nedostatočný účinok
• Sedácia (0-10 číselná škála)
• Nauzea (0-10 číselná škála)
• Zápcha (0-10 číselná škála)
• Celkové zhodnotenie odpovede na liečbu skúšajúcim a pacientom
• Zhodnotenie Kvality života (EORTC)
Sekundárnymi cieľmi bezpečnosti tejto štúdie sú:
• nežiaduce príhody
• lokálna tolerancia
• vitálne funkcie
• klinické laboratórne vyšetrenia
• 12-zvodové EKG
|
|
| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
| Pharmacokinetic sub-study (implemented in main protocol), 03.12.2010, version 01, final |
|
| E.3 | Principal inclusion criteria |
Male or female patients aged 18 to 75 with a diagnosis of cancer;
Documented history of moderate to severe chronic cancer pain requiring around-the-clock therapy and are likely to benefit from WHO step III opioid analgesics for the duration of the study;
Stable but inadequately controlled pain (with present breakthrough pain attacks) with current therapy for at least two weeks;
Pain intensity, as assessed by the pain intensity numerical rating scale during Visit 1, meets the definition of „moderate“ (score of 4-5) or „severe“ (score of 6-10) pain;
Life expectancy of more than 3 months;
Male, or female patients with childbearing potential who must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation;
Ability to understand and willingness to sign a written informed consent.
|
|
| E.4 | Principal exclusion criteria |
Known hypersensitivity or intolerance to opioid analgesics or any excipient of the investigational products;
Planned initiation of chemotherapy, radiotherapy, or bisphosphonates treatment during the course of the study or within 30 days prior to randomization;
Scheduled elective surgery or other invasive procedures during the period of study participation;
Received an investigational drug within 30 days prior to screening or who is scheduled to receive an other investigational drug during the course of the study;
Any ongoing serious adverse events (SAEs) at screening;
Respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, (obstructive) sleep apnea syndrome, paralytic ileus;
Known history of uncontrolled seizures, increased intracranial pressure;
Evidence of clinically significant cardiovascular, renal, hepatic, CNS or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination, that would place the patient at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the results;
Abnormal laboratory findings during screening (these patients will be not randomized): aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT) levels more than 3 times the upper level of normal; total bilirubin level more than 1.5 times the upper level of normal creatinine clearance less than 50 ml/min (calculated using the Cockcroft-Gault formula);
Patients who are receiving hypnotics or other central nervous system (CNS) depressants that, in the opinion of the investigator, may pose a risk of additional CNS depression with opioid medication;
Taking lidocaine, mexiletine or other anaesthetics;
Use of scopolamine, acetylcholinesterase-inhibiting drugs, beta-blockers and antiarrythmic drugs;
Patients with myxoedema, inadequately controlled hypothyroidism or Addisons disease;
Active skin disease;
Patients suffering from diarrhea and/or opioid withdrawal;
Known positive Hepatitis B or C or HIV status;
History of alcohol and/or drug abuse within one year preceding the Screening Visit;
Patients who are pregnant, breast feeding or women of childbearing potential. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of reproductive potential, to include female partners of heterosexual or bisexual patients, must agree to use an effective method of contraception during the study and for up to three months following termination of the study.
Is an employee of the investigator or study site with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of the employees or the investigator.
Unwilling or unable to comply with the protocol
Any other condition that, in the opinion of the investigator, is likely to interfere with the successful collection of the measures required for the study or poses a risk to the patient.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary endpoint is the consumption (mg) of rescue analgesia (immediate release morphine sulfate tablets) per day during the maintenance period (Visit 9 to Visit 13).
The ITT population will be considered primary for the efficacy analyses and comprises of all randomized patients who receive at least 1 dose of study treatment.
Data will be summarized and analyzed descriptively and graphically for the primary endpoint, each 24-hour period, and each 4-hour period. Differences between the treatment groups with 95% confidence intervals will be calculated using appropriate parametric and/or non-parametric methods.
|
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| End of the study, no interim analysis is planned |
|
| E.5.2 | Secondary end point(s) |
The secondary efficacy objectives of this study are to evaluate:
• Rescue analgesic use (doses/day and time of day)
• Pain intensity (0-10 numerical scale)
• Incidence and time (days) to withdrawal due to lack of efficacy
• Sedation (0-10 numerical scale)
• Nausea (0-10 numerical scale)
• Constipation (0-10 numerical scale)
• Investigators and patient’s global assessment of response to therapy
• Quality of life assessment (EORTC)
The secondary safety objectives of this study are to evaluate:
• adverse events
• local tolerance
• vital signs
• clinical laboratory evaluations
• 12-lead ECG
|
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| End of the study, no interim analysis is planned |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| 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
|
| Study participation will be normally finished at Visit 14, in case of premature withdrawal all procerudes described for the Visit 13 will be performed. Afterwards patients treatment will be in discretion of the investigators. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 8 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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