EUCTR2007-004331-27-ES进行中（未招募）1 期
Estudio multicéntrico, aleatorizado, doble ciego y controlado con vehículo para evaluar la seguridad y la eficacia de SCH 900340 solución al 5% comparado con el vehículo, administrado por vía tópica en el tratamiento de la onicomicosis subungueal distal de la uña del pie. NOTE: The product to be used in the clinical trial is a Topical Solution. Of the choices provided in Section D.3.4 Pharmaceutical Form; per the standard list, Medicated Nail Lacquer was selected at this time.
Schering-Plough Research Institute, a Division of Schering Corporation0 个研究点目标入组 600 人开始时间: 2008年9月26日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
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
入选标准
- •1. Subjects must be 18 to 75 years of age (both inclusive) at Screening, and can be of either sex and of any race.
- •2. Subjects must have distal subungual onychomycosis due to dermatophytes that:
- •(a) involves at least 25% of the total area (ie, the area circumscribed by the distal groove and the proximal and lateral nail folds) of the target great toenail according to the investigator's visual inspection after properly trimming the nail
- •(b) does not involve the proximal 25% of the nail (no nail matrix involvement)
- •(c) has been mycologically confirmed at Screening (central laboratory KOH and central laboratory culture positive for dermatophytes).
- •3. Subjects must have the target great toenail capable of growing, as assessed by the investigator during Screening.
- •4. Subjects must have a thickness of the distal target great toenail plate of =3 mm as measured at Screening by the investigator or a subinvestigator.
- •5. Subjects must be able to apply the study drug to their toenails.
- •6. Subjects must agree to use no other products (including nail polish) applied to the toenails during the study.
- •7. Subjects' clinical laboratory tests (hematology and blood chemistries) must be clinically acceptable to the investigator.
- •8. Women of child-bearing potential who are currently sexually active must agree to use a medically accepted method of contraception prior to randomization, while receiving protocol-specified medication, and for 4 weeks after stopping the medication. Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal ligation).
- •9. Women of child-bearing potential who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating 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. Subjects with anatomic abnormalities of the target great toenail, including but not limited to genetic nail disorders, pigmentary disorders, onychogryposis, trauma to the nail, and/or any other abnormalities that in the investigator's judgment may interfere with efficacy assessments.
- •2. Subjects with one or more of the following conditions on the target great toenail:
- •a. proximal subungual onychomycosis,
- •b. white superficial onychomycosis, dermatophytoma, exclusively lateral disease, or yellow/brown spikes,
- •c. any non-dermatophyte infection (eg, Scopulariopsis spp and Scytialidium spp),
- •d. any other condition (eg, past history of trauma) that in the opinion of the Investigator could interfere with the ability of the investigator to assess the subject's response to the study medication.
- •3. Subjects with a current or past history of psoriasis and/or lichen planus.
- •4. Subjects with clinically significant nonfasting serum glucose levels at Screening will have a repeat fasting test including glucose and hemoglobin A1C (Hgb A1C) during the Screening phase. Subjects with Hgb A1C =8% will be excluded from the study.
- •5. Subjects with significant peripheral vascular disease or peripheral circulatory impairment, as evidenced by absence of dorsalis pedis or posterior tibial pulses.
- •6. Subjects with chronic tinea pedis (eg, moccasin type) that in the investigator's judgment would require systemic therapy.
- •7. Subjects with a history of chronic mucocutaneous candidiasis.
- •8. Subjects with a history of any known immunodeficiency.
- •9. Subjects with a history of treatment failure (defined as no recognized increase in clear nail growth) after completion of =3 months of any oral antifungal administered according to label.
- •10. Subjects who have received treatment for any type of cancer within the last 6 months, except non melanoma skin cancer.
- •11. Subjects who have received any treatment listed below more recently than the indicated washout period or who must continue to receive such treatments:
- •Prohibited Medications (Washout Period)
- •-Systemic antifungal treatments (24 weeks prior to Screening),
- •-Topical antifungal agents applied to the toenails, excluding antifungal agents for the treatment of tinea pedis (12 weeks prior to Screening),
- •-Oral or intramuscular corticosteroid and oral or intramuscular immunosuppressive agents (4 weeks prior to Screening),
- •-Topical anti-inflammatory, topical corticosteroid, and topical immunosuppressive agents applied to the feet (2 weeks prior to Day 1),
- •-Investigational drugs (4 weeks prior to Screening),
- •-Topical antifungal agents for the treatment of tinea pedis (1 week prior to Screening).
- •12. Subjects with a history of street drug or alcohol abuse within 6 months prior to Screening, as determined by the investigator.
- •13. Women who are breast-feeding, pregnant, or intend to become pregnant.
研究者
相似试验
进行中（未招募）
不适用
Estudio multicéntrico, aleatorizado, doble ciego y con doble simulación para evaluar dos dosis de adalimumab frente a metotrexato (MTX) en pacientes pediátricos con psoriasis (Ps) en placas crónica A Multi-centre, Randomised, Double-Dummy, Double-Blind Study Evaluating Two Doses of Adalimumab versus Methotrexate (MTX) in Paediatric Subjects with Chronic Plaque Psoriasis (Ps)EUCTR2009-013072-52-ESAbbott GmbH & Co. KG111
进行中（未招募）
不适用
Estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo diseñado para demostrar la eficacia y la seguridad del adalimumab como tratamiento de mantenimiento en sujetos adultos que precisan corticosteroides en dosis altas por uveítis intermedia, uveítis posterior opanuveítis no infecciosa activa. - N/Aveítis intermedia, uveítis posterior o panuveítis no infecciosa activaActive Non-infectious Intermediate-, Posterior-, or Pan-uveitisMedDRA version: 12.1Level: LLTClassification code 10022557Term: Intermediate uveitisMedDRA version: 12.1Level: LLTClassification code 10033687Term: PanuveitisMedDRA version: 12.1Level: LLTClassification code 10036370Term: Posterior uveitisEUCTR2009-016095-68-ESAbbott GmbH & Co. KG250
进行中（未招募）
1 期
Estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo, para evaluar la seguridad y eficacia de SCH 530348 añadido al tratamiento estándar, en sujetos con síndrome coronario agudo: Antagonista del Receptor de Trombina en la Reducción de los Episodios Clínicos en síndrome coronario agudo (TRA•CER). A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With Acute Coronary Syndrome: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA•CER). - TRA•CERSíndrome coronario agudo.MedDRA version: 9.1 Level: LLT Classification code 10051592 Term: Acute coronary syndromeEUCTR2006-002809-31-ESSchering-Plough Research Institute10,000
进行中（未招募）
1 期
Estudio multicéntrico, aleatorizado, doble ciego y controlado con tratamiento activo de pacientes con hipercolesterolemia primaria y riesgo cardiovascular elevado que no están controlados adecuadamente con atorvastatina 10 mg: comparación de la eficacia y la seguridad del cambio a la administración conjunta de ezetimiba y atorvastatina frente a la duplicación de la dosis de atorvastatina o el cambio a rosuvastatina A Randomized, Double-Blind, Active-Controlled, Multicenter Study of Patients with Primary Hypercholesterolemia and High Cardiovascular Risk Who Are Not Adequately Controlled with Atorvastatin 10 mg: A Comparison of the Efficacy and Safety of Switching to Coadministration Ezetimibe and Atorvastatin Versus Doubling the Dose of Atorvastatin or Switching to Rosuvastatin - SWITCHPrimary Hypercholesterolemia Hipercolesterolemia primariaMedDRA version: 12.1 Level: LLT Classification code 10020603 Term: HypercholesterolaemiaEUCTR2009-015247-16-ESMerck Sharp & Dohme Corp.1,508
进行中（未招募）
1 期
Estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar resultados cardiovasculares después del tratamiento con alogliptina en combinación con la asistencia habitual en sujetos con diabetes tipo 2 y síndrome coronario agudo. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to EvaluateCardiovascular Outcomes Following Treatment with Alogliptin in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary SyndromeDiabetes mellitus tipo 2 (DMT2) y síndrome coronario agudo (SCA).type 2 diabetes mellitus (T2DM) and acute coronary syndrome (ACS)MedDRA version: 12.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusMedDRA version: 12.0Level: LLTClassification code 10051592Term: Acute coronary syndromeEUCTR2009-011222-34-ESTakeda Global Research & Development Centre (Europe) Ltd.5,400