EUCTR2008-002472-99-DE进行中（未招募）不适用
A phase II multicenter, randomised, double-blind, parallel group, placebo-controlled, study to evaluate the effectiveness of EVT 302 in smoking cessation, effect on its own and in combination with open label nicotine replacement
Evotec Neurosciences GmbH0 个研究点开始时间: 2008年6月6日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1. Male or female, 18 to 70 years of age.
- •2. Body Mass Index (BMI) > 18 and < 31 kg/m2.
- •3. Agrees to abstain from taking any prescription or non-prescription drugs (except as authorised by the Investigator) for seven days prior to the first dose of study drug through the end of the study. Exceptions include multivitamins, oral contraceptives, and topical agents.
- •4. Smoker of at least 10 cigarettes daily and no more than 1 month of continued abstinence in the last 12 months.
- •5. Motivated to quit smoking.
- •6. Reports at least one unsuccessful attempt to quit smoking in the last 2 years.
- •7. Agrees to attend study visits and complete required assessments.
- •8. In generally good health based on medical history and clinically acceptable results on the following assessments: physical examination, vital signs, clinical chemistry (liver function test (LFT) results for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) at screening not above 1.5 times the upper limit of normal (ULN)), haematology, urinalysis, and 12 lead electrocardiogram (ECG). Seated systolic blood pressure must be >90 mmHg and =150 mmHg and seated diastolic blood pressure must be >50 mmHg and =95 mmHg at screening and baseline.
- •9. Able and agrees to complete diary and questionnaires, communicate effectively with study personnel and be considered reliable, willing and cooperative in terms of compliance with the protocol requirements.
- •10. Voluntarily gives written informed consent to participate in the study.
- •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
排除标准
- •1. Female subjects currently pregnant and/or nursing. Non-pregnancy of women with childbearing potential will be confirmed by serum pregnancy tests conducted at screening. Women without childbearing potential are those hysterectomised, sterile or post menopausal with amenorrhoea of least one year duration. Women of childbearing potential will agree to use an acceptable form of birth control (contraceptive pill and barrier contraception - partner using condom or subject using spermicide, diaphragm or contraceptive sponge) during the study and for at least 2 months after completing the study. Male subjects must agree to use either double-barrier contraception or their partner must use the contraceptive pill during the study and for at least 2 months after completing the study.
- •2. Has a history of anaphylaxis with clinical signs, a documented immunological hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug. A history of rash after penicillin intake without hospitalisation is acceptable.
- •3. Has a history or presence of abuse of alcohol, licit or illicit drug substances within the last 12 months (abuse of alcohol defined as intake of more than 15 units of alcohol weekly for men and 10 units weekly for women where 1 unit corresponds to 285 mL beer, 125 mL wine and 25 mL spirit, respectively), or a positive drug screen for drugs of abuse (including tetrahydrocannabinol for marijuana and breath test for alcohol).
- •4. History of or current significant medical (e.g. cardiovascular, hepatic, endocrine, bronchopulmonary and neurological, but not exclusively) or psychiatric disorder (including schizophrenia, seasonal affective and other mood disorders, history of or current tendency for suicidal thoughts and suicidal attempts) that may pose a risk to the subject in this study or adversely interact with study measures or the subject’s ability to participate in the study. Mild stable forms of diseases such as chronic obstructive pulmonary disease (COPD) are acceptable, and potentially eligible on a case-by case decision between Sponsor and Investigator.
- •5. Major depressive disorder within the last 12 months or a Hamilton Rating Scale for Depression (HAM-D) 17 score of more than 12 at screening.
- •6. History or presence of cataract (or abnormality identified by slit lamp examination during screening), uveitis, eye trauma or eye irradiation. Minor ophthalmological findings outside lens and cornea discovered during the ophthalmological screening should not lead to exclusion.
- •7. Use of any medication that may adversely interact with study measures (antidepressants, typical and atypical antipsychotics, anxiolytics and hypnotics, antiepileptics, others); recent or regular use of an opioid medication.
- •8. Use of other MAO inhibitors, pethidine, SSRIs, TCAs, nasal and oral decongestants or cold medicines containing ephedrine, pseudoephedrine, other sympathomimetics (including epinephrine and norepinephrine) and any medication forbidden to be co-administered with MAO inhibitors (e.g. linezolid, albuterol). Occasional use of non-sedative anti-histamines is acceptable.
- •9. Are known to have or are a carrier of the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, has a positive result to the human immunodeficiency virus-1 and/or 2 (HIV-1 and/or HIV-2) antibodies.
- •10. Blood donation within the last two months or planned during the study and two months afterwards.
- •11. Unwillingness to attend study visits, or
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