EUCTR2009-017197-21-BE进行中（未招募）1 期
A multicenter, open-label, single ascending dose study to evaluate pharmacokinetics, safety and tolerability of solifenacin succinate suspension in pediatric patients aged 5 to 17 years (inclusive) with Overactive Bladder (OAB)Protocol for Phase I Study of solifenacin succinate suspensionSingle ascending dose PK study - GIRAFFE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
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. Symptoms of urgency, diagnosed as OAB according to International Children’s Continence Society (ICCS) criteria.
- •2. Daytime urgency incontinence at least once/day.
- •3. Patient is 5 to 11 (inclusive) or 12 to 17 (inclusive) years of age.
- •4. Weight and height are within normal age percentiles (3% to 97%) according to local country standards.
- •5. Patient and patient’s parent(s)/legal guardian are willing and able to comply with the study requirements and with the concomitant medication restrictions.
- •6. Informed consent (patient’s parent(s)/legal guardian) has been obtained; assent (patient) where appropriate is given.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •At screening:
- •1. Daytime voiding frequency less than 5.
- •2. Extraordinary daytime urinary frequency. Diagnosis according to ICCS definition:
- •daytime voiding frequency is at least once hourly and
- •average voided volumes are less than 50% of expected bladder capacity.
- •3. Uroflow indicative of pathology other than OAB.
- •4. Maximum voided volume > age expected capacity ([age +1] x 30) in ml.
- •5. PVR > 10% of the functional bladder capacity.
- •6. Monosymptomatic enuresis.
- •7. Polyuria.
- •8. Dysfunctional voiding.
- •9. Congenital anomalies of the genito-urinary tract or nervous system.
- •10. Current constipation (when treated the patient can enter the study).
- •11. Current urinary tract infection (patient will be eligible for enrolment 14 days after a negative dipstick test, provided a second dipstick test, performed after these 14 days, is also negative).
- •12. Kidney / bladder stones or other persistent local pathology that may cause urinary symptoms.
- •13. Urinary indwelling catheter within 4 weeks prior to study entry.
- •14. Patients with the following gastro-intestinal problems: partial or complete obstruction, decreased motility such as paralytic ileus, patients at risk of gastric retention.
- •15. Any clinically significant abnormality on physical examination.
- •16. Known history of QTc prolongation or risk of QT prolongation (e.g., hypokalemia,
- •family history of Long QT Syndrome [LQTS]).
- •17. Abnormal pulse rate (mean value) according to ranges specified below [Rijnbeek et al, 2001], judged as clinically significant by the investigator.
- •- age 5-7 years: <60 beats per minute (bpm) or >110 bpm
- •- age 8-11 years: <55 bpm or >100 bpm
- •- age 12-17 years: <50 bpm or >100 bpm
- •18. Mean systolic blood pressure greater than the 95th percentile according to age and height and/or greater than 140 mmHg, judged as clinically significant by the
- •investigator; mean diastolic blood pressure greater than the 95th percentile according to age and height and/or greater than 90 mmHg, judged as clinically significant by the investigator.
- •19. History or presence of any malignancy.
- •20. Any clinically significant unstable medical condition or disorder, which in the opinion of the investigator precludes the patient from participating in the study.
- •21. Serum creatinine more than or equal to 2 times the upper limit of normal (ULN).
- •22. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than or equal to 2 times ULN, or bilirubin more than or equal to 1.5 times ULN.
- •23. Any other clinically significant out of range results of urinalysis, biochemistry or
- •hematology.
- •24. Any clinically significant abnormality on ECG.
- •25. Patient is breastfeeding, pregnant or intends to become pregnant during the study. Patients of childbearing potential who are sexually active must practice a highly reliable method of birth control (these are methods with a failure quotient of <1% per year such as hormonal implants, injectable contraceptives, oral contraceptives of combination type, intra-uterine pessaries restricted to hormone contraceptive coil, sexual abstinence or vasectomy of the partner). Note: the pregnancy test (ß-HCG in serum) at screening, which is to be performed in females of childbearing potential, needs to be negative.
- •26. Patient has participated in another clinical trial and/or has taken an investigational drug within 30 days (or 5 half-lives of the drug, or the limit set by national law, whichever is longer) prior to Day 1.
- •33. Consumption of grapefruit, grap
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