EUCTR2009-015397-35-DE进行中（未招募）不适用
A multicenter, open-label trial to assess cognitive and psychomotor performance as surrogate parameters for driving ability under stable long term treatment with tapentadol hydrochloride prolonged-release tablets in subjects with chronic low back pain or osteoarthritis of the knee.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •- 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.
研究者
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