Pain MedDRA version: 14.0 Level: PT Classification code 10033371 Term: Pain System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Interventions
Sponsors
Grünenthal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject must have signed the Informed Consent Form. - Subject must be at least 18 years of age but younger than 70 years old (to be eligible for the Vienna Test System - Traffic). - Subject must have completed one of the trials KF5503/42, KF5503/43, KF5503/44, or KF5503/45. - Subject must have taken a stable dose of tapentadol hydrochloride PR for at least 2 weeks. - Subject must be fluent in German language (verbal and written) according to the judgment of the Investigator. - Subject must be a man or a non-pregnant, non-lactating woman. A sexually active woman must be postmenopausal, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization) before entry and throughout the trial. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - Known to or suspected of not being able to comply with the protocol. - Pregnancy or breastfeeding mother. - History of alcohol or drug abuse, or suspicion thereof in the Investigator’s judgment. - Subject is an employee of the Investigator (from originating center) or test center, with direct involvement in this trial or other trials under the direction of the Investigator or test center, or a family member of an employee of the Investigator. - Diagnosis of severe renal impairment. - Diagnosis of moderately or severely impaired hepatic function. - Any of the following within the last year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm. Severe traumatic brain injury within 15 years (consisting of =1 of the following: brain contusion, intracranial hematoma, either unconsciousness or post-traumatic amnesia lasting more than 24 h) or residual sequelae suggesting transient changes in consciousness. - History of seizure disorder or epilepsy. - History of allergy, or hypersensitivity to tapentadol hydrochloride or the excipients of the formulation used, or contraindications related to tapentadol hydrochloride including: - Subjects with acute or severe bronchial asthma or hypercapnia - Subjects who have or are suspected of having paralytic ileus. - Participation in a trial other than KF5503/42, KF5503/43, KF5503/44, or KF5503/45 concurrently or within 4 weeks prior to the Enrollment Visit, or previous participation in this trial. Trial specific - Subject is taking disallowed medication (see list of disallowed medications). - Subject has a physical, neurological, or psychological disability or symptoms that would interfere with performing the Vienna Test System - Traffic. - Positive urine drug screen (with exception for opioids). - Pending litigation due to chronic pain or disability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the cognitive and psychomotor performance as measured by a validated methodology (Vienna Test System – Traffic Plus) based on a global judgment as the key outcome surrogate parameter for driving ability in subjects with chronic non-malignant pain under stable treatment with tapentadol hydrochloride PR.;Secondary Objective: n.a.;Primary end point(s): not applicable, please refer to E.5.2;Timepoint(s) of evaluation of this end point: not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Only secondary endpoint criteria of KF5503/53 will be maintained, no more (descriptive) primary endpoint defined .The global judgment is the key outcome surrogate parameter for driving ability. The original primary endpoint is maintained in the analyses reflecting a small subset of the global judgement outcome groups. The following main effectiveness endpoints will be analyzed - Global judgment as key outcome surrogate parameter for driving ability - Binary outcome created for each of the individual performance tests of the Vienna test system. - Pain intensitiy scores at enrollment-, test- and the final visit;Timepoint(s) of evaluation of this end point: LSO | — |
Countries
Germany
Contacts
Public ContactClinical Development Operations
Grünenthal GmbH
Outcome results
None listed