NCT00245505终止3 期
The Effect on Mucosal Healing With Pentasa Sachet 4g in Mild to Moderate Active Small Bowel Crohn´s Disease, Evaluated by Video Capsule Endoscopy After 6 and 12 Weeks Treatment. A Pilot Study
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Mucosal changes, (measured as number, type and localization of small bowel mucosal lesions detected by VCE) from baseline (i.e. < 7 days prior to inclusion), and after 6 and 12 weeks´ treatment with 4g Pentasa Sachet
研究概览
简要总结
The purpose of this study is to visualize the healing effect on mucosal lesions with Pentasa Sachet 4g in patients with mild to moderate active small bowel CD by video capsule endoscopy.
详细描述
The purpose of this study is to visualize the healing effect on mucosal lesions with Pentasa Sachet 4g in patients with mild to moderate active small bowel CD by video capsule endoscopy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •4.2 Inclusion Criteria
- •Patients who have signed the informed consent form
- •Patients with performed complete VCE < 7 days prior to inclusion and diagnosed clinically active mild to moderate small bowel CD and no stricture on previous examinations, as previously proven by barium small bowel follow through, enteroclysis and / or patency test capsule.
- •Patients between 18 - 70 years of age.
排除标准
- •Patients with evidence of other forms of inflammatory small bowel bowel disease, idiopathic proctitis or infectious disease.
- •Patients with known small bowel strictures from previous examinations with for instance barium small bowel follow through, enteroclysis and / or patency capsule test.
- •Patients with pacemaker due to lack of VCE interaction data.
- •Patients who cannot undergo study procedures due to swallowing disorders.
- •Planned or actual pregnancy or lactation.
- •Women of child-bearing potential who are not using an effective method of contraception, in the opinion of the investigator.
- •8. Patients receiving maintenance treatment (p.o.) with total daily doses above 2.0g of sulphasalazine, mesalazine or 4-ASA, for 30 days prior to entry into the study.
- •9. Chronic use of non-steroidal anti-inflammatory drugs (oral and/or rectal routes) in 30 days prior to inclusion in the study (chronic use is defined as drug intake for a minimum of 3 consecutive days).
- •10. Intake of corticosteroids (oral and/or rectal routes) within the 30 days prior to enrolment in the study.
- •11. Patients receiving any immunosuppressive (azathioprine, 6-MP, etc) agents during 30 days prior to study enrolment.
- •12. Patients receiving any Crohn specific biological agents (TNF-alfa) during the last year prior to study enrolment.
- •13. Patients with any other disease or condition which may interfere with study assessments as judged by the investigator.
- •14. Alcoholism or drug addiction.
- •Patients participating or having participated in another clinical study in the previous 30 days.
- •16. Patients with severe renal/hepatic impairment (see section 5.6) as judged by the investigator.
- •17. Patients who are allergic to salicylate or 5-ASA derivatives.
- •Patients who are unlikely to comply with the protocol.
- •Any patient who has previously taken part in this study.
- •Patients who are unable to write or read local language
结局指标
主要结局
Mucosal changes, (measured as number, type and localization of small bowel mucosal lesions detected by VCE) from baseline (i.e. < 7 days prior to inclusion), and after 6 and 12 weeks´ treatment with 4g Pentasa Sachet
时间窗: 12 weeks
次要结局
- CDAI changes and laboratory changes(12 weeks)
研究者
研究点 (2)
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