A Phase 3, Open Label, Multicenter Study to Assess the Safety and Tolerability of Budesonide Foam in Subjects With Active Ulcerative Proctitis or Proctosigmoiditis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Number Of Participants Reporting A Non-serious Adverse Event And A Serious Adverse Event
研究概览
简要总结
The purpose of this study is to evaluate safety and tolerability of cyclically-dosed rectal budesonide foam in participants with active ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS).
详细描述
This is a Phase 3, multicenter, open-label study in participants who previously participated in a Salix-sponsored budesonide rectal foam study for the treatment of UP or UPS. Approximately 300 participants were to be enrolled into the study and receive budesonide foam cyclically for 6 weeks (twice a day [BID] for 2 weeks and once daily [QD] for 4 weeks). The study was to continue until regulatory approval of budesonide foam occurred or the sponsor decided to terminate the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant, non-breast-feeding females ≥18 years old.
- •Participant was previously diagnosed with active mild to moderate UP/UPS and was currently experiencing symptoms of active UP/UPS disease after having completed participation in Salix's BUCF3001 (NCT01008410) or BUCF3002 (NCT01008423) study.
- •Willingness to undergo sigmoidoscopy.
排除标准
- •Active systemic, ocular, or cutaneous infection (for example, parasitic, fungal, amoebic, viral, or bacterial disease).
- •History of sclerosing cholangitis, cirrhosis, or hepatic impairment, including chronic hepatitis of any etiology.
- •Participant took systemic, inhaled, oral, topical, or rectal corticosteroids (other than budesonide rectal foam) within 7 days of starting a treatment cycle.
- •Participant took ketoconazole and other potent CYP3A4 inhibitors within 7 days of starting a treatment cycle.
- •Participant took diuretics with cardiac glycosides.
- •Unstable significant cardiovascular, hepatic, renal, endocrine, neurologic, or pulmonary disease.
研究组 & 干预措施
Budesonide Foam
Participants administered topical rectal budesonide foam at 2 mg/25 mL BID (morning and 12 hours later) for 2 weeks followed by 2 mg/25 mL QD (in the evenings) for 4 weeks for up to 8 cycles. After Cycle 1, participants needed to qualify to be able to participate in subsequent cycles. Participants underwent a 48-hour study drug washout period between each cycle.
干预措施: Budesonide Foam (Drug)
结局指标
主要结局
Number Of Participants Reporting A Non-serious Adverse Event And A Serious Adverse Event
时间窗: Baseline through up to Cycle 8 (Cycle=6 weeks)
A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
次要结局
- Clinically Notable Laboratory Parameters(Baseline and Cycle 4 (Cycle=6 weeks))
- Changes In Baseline In Mean Morning (AM) Fasting Serum Cortisol Levels(Baseline of Cycles 1-4, Day 15 and Day 42 of Cycles 1-4 (Cycle=6 weeks))
- Number of Participants With A Clinically Notable Physical Examination Finding Since Baseline(Baseline through up to Cycle 8 (Cycle=6 weeks))