Severe chronic pain MedDRA version: 12.1 Level: LLT Classification code 10049475 Term: Chronic pain
Conditions
Interventions
Product Name: Tapentadol 50 mg film coated tablet
Product Code: CG5503
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tapendol hydrochlori
R331333
Other descriptive name: 3-[(1R,2R)-3-(dimethylamino)1-ethyl-2-methylpropyl]phenol-hydrochloride
Concentration unit: mg milligram(s)
Concentratio
Sponsors
Laboratoires Grünenthal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main (general) inclusion criteria 1. Patients who have signed the informed consent form, confirming that they understand the purpose and procedures of the study, and that they wish to participate in it. 2. Males or females who are not pregnant or nursing. Postmenopausal women or women of child-bearing potential who are sexually active and have been surgically sterilized or who use an adequate contraceptive method (e.g. oral contraceptives under medical prescription, contraceptive injections, intrauterine devices, double barrier methods, contraceptive patches), both before inclusion and throughout the study period. Women of child-bearing potential must have a negative result in the pregnancy test carried out during the last visit of the preceding protocol. 3. Patients capable of verbalizing and discriminating information relating to pain location and intensity. 4. Patients agreeing not to receive any other investigational drug other than tapentadol hydrochloride during the entire extension study, i.e. the patients may not participate in any other clinical study involving the administration of an investigational drug or the use of an experimental device. Main (study-specific) inclusion criteria 5. Patients who complete the continuation period (Weeks 9 to 12) of any one of the preceding protocols KF5503/42, KF5503/44 or KF5503/45, with no major violation of the protocol. 6. Patients who have complied with the minimum titration objective of the preceding protocol and who continue to do so at the baseline visit of the present extension protocol. 7. Patients who, in the Investigator’s opinion, could benefit from continued treatment with tapentadol hydrochloride for severe chronic low back pain (studies KF5503/44 and KF5503/45) or for severe chronic pain due to knee osteoarthritis (study KF5503/42). 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Main (general) exclusion criteria 1. Known or suspected drug or alcohol abuse (in the Investigator’s opinion). 2. Presence of a clinically significant disease or laboratory findings that in the Investigator’s opinion may affect efficacy or safety assessments. 3. Presence of active systemic or local infection, that may, in the opinion of the Investigator, affect the efficacy, quality of life/function or safety assessments. 4. Presence of concomitant autoimmune inflammatory disease. 5. A known history or laboratory test findings indicative of severe renal failure (to be confirmed when the results of the sample corresponding to Visit 12 of the preceding protocol become available). 6. A known history of moderate to severe hepatic impairment (to be confirmed when the results of the sample corresponding to Visit 12 of the preceding protocol become available). 7. A history of chronic or active hepatitis B or C in the previous three months, or a history of HIV infection. 8. A history of seizures or epilepsy. 9. Any of the following conditions in the previous year: mild to moderate craniocerebral injuries, stroke, transient ischemic attack or brain neoplasm. Severe craniocerebral injuries in the previous 15 years (with the presence of one or more of the following: brain contusion, intracranial hematoma or post-traumatic unconsciousness or amnesia lasting over 24 hours), or sequelae suggesting transient modification of consciousness. 10. Pregnant or nursing women. 11. A contraindication to or history of allergy or hypersensitivity to tapentadol hydrochloride, including: - Patients with acute or severe bronchial asthma or hypercapnia. - Patients with suspected or confirmed paralytic ileus. - Patients with suspected or confirmed respiratory depression. 12. Employees of the Investigator or study centre, with a direct relation to the present study or other studies headed by the same Investigator or study centre, as well as relatives of the employees or Investigator. 13. Simultaneous participation in another clinical trial. 14. Subjects unable or suspected to be unable to comply with the study protocol or with use of the investigational drugs. 15. Patients using monoamine oxidase inhibitors (MAOIs). 16. Use of selective serotonin reuptake inhibitors (SSRIs) at non-stable doses (the doses are to remain stable throughout the study). Exclusion criteria 5 and 6 cannot be checked until the results of the blood sample tests corresponding to Visit 12 of the preceding protocol become available. Nevertheless, the Investigator will include those patients not suspected to fail to comply with these criteria, in order to avoid treatment interruptions. If, subsequently, some unexpected anomaly is recorded in the corresponding laboratory tests, the patient in question is to be withdrawn from the study. Main (study-specific) exclusion criteria 17. Premature discontinuation of treatment with tapentadol hydrochloride during the preceding study, for any reason. 18. The patients are to continue to comply with all the other specific exclusion criteria of the preceding protocol, with the except
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Given the nature of the study, only a descriptive analysis will be done of the evaluations indicated below, and no primary efficacy criterion or endpoint has been defined.;Main Objective: The principal objective is to offer treatment with tapentadol hydrochloride to patients who have completed clinical trials KF5503/42, KF5503/44 or KF5503/45, and who could benefit from continued analgesic therapy with tapentadol.; Secondary Objective: Evaluation of the long-term efficacy, tolerability and safety of continued treatment with tapentadol hydrochloride in patients with severe chronic low back pain or severe chronic pain due to knee osteoarthritis and who have completed clinical trials KF5503/42, KF5503/44 or KF5503/45. Evaluation of the long-term WHO Step I analgesics and/or co-analgesics sparing effect of tapentadol hydrochloride in subjects who previously have reduced or stopped these drugs during Substudy A of the preceding protocols. | — |
Countries
France
Outcome results
None listed