NCT00774969已完成1 期
Phase 1 Study to Evaluate the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri-Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate the blood levels of Metronidazole after application to the peri anal area after a single dose and 6 or 7 days application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient group:
- •Male and female patients with Crohn's disease (diagnosed by radiology, endoscopy and pathology), with anorectal involvement.
- •Aged 18-65 years.
- •Have had perianal symptoms for longer than 2 months
- •Have a score of 5 or above in the Perianal Crohn's Disease Activity Index (PCDAI)
- •Have a score of 1 or above on the 'Type of perianal disease' assessment of the PCDAI
- •Subjects can be on concomitant medication. Acceptable regimens are:
- •Aminosalicylates at a dosage that has been stable for more than 4 weeks before screening;Infliximab on a stable infusion regimen;
- •Oral corticosteroids <40mg per day; Methotrexate, provided that dosage has been stable for more than 4 weeks; azathioprine or mercaptopurine at a dosage that has been stable for more than 8 weeks;
- •Antibiotics at a dosage that has been stable for 4 weeks but excluding metronidazole.
- •Cyclosporin on a stable dose for more than 4 weeks.
- •If patients have setons these must have been in place for at least 4 weeks prior to screening.
- •If female, the subject must not be lactating and must be (a) post-menopausal, (b) surgically sterilised, or (c) have a negative pregnancy test result prior to entry into the study and will use double-barrier methods of contraception (two separate methods of birth control, one of which may include oral contraception) for the duration of the study.
- •Must have provided written informed consent to participate.
- •Healthy volunteer group:
- •They have had surgery to the anus or rectum in the past 4 weeks.
- •Have a history of inflammatory bowel disease.
- •Allergic to metronidazole.
- •Are taking any prohibited medication.
- •Not prepared to refrain from drinking alcohol during the course of the study.
- •Deemed mentally incompetent.
- •Considered by their physician unlikely to be able to comply with the protocol.
- •Has donated blood within the past 3 months.
- •Taken part in an experimental drug study in the preceding three months.
排除标准
- •Patient group:
- •They have had surgery to the anus or rectum in the past 4 weeks.
- •They have a perianal abscess requiring incision and drainage.
- •They have a stoma of less than 6 months duration.
- •Allergic to metronidazole.
- •Are taking any prohibited medication.
- •Not prepared to refrain from drinking alcohol during the course of the study.
- •Deemed mentally incompetent.
- •Considered by their physician unlikely to be able to comply with the protocol.
- •Has donated blood within the past 3 months.
- •Taken part in an experimental drug study in the preceding three months.
- •Has donated blood within the past 3 months.
- •Taken part in an experimental drug study in the preceding three months.
- •Healthy volunteer group:
- •They have had surgery to the anus or rectum in the past 4 weeks.
- •Have a history of inflammatory bowel disease.
- •Allergic to metronidazole.
- •Are taking any prohibited medication.
- •Not prepared to refrain from drinking alcohol during the course of the study.
- •Deemed mentally incompetent.
- •Considered by their physician unlikely to be able to comply with the protocol.
- •Has donated blood within the past 3 months.
- •Taken part in an experimental drug study in the preceding three months.
研究组 & 干预措施
All
Experimental
6 patients with Perianal Crohn's Disease and 10 healthy Volunteers
干预措施: Metronidazole (Drug)
研究者
研究点 (1)
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