NCT01327703已完成4 期
An Open-label, Multicenter, Randomized, Cross-over Study to Compare the Safety and Efficacy of PANZYTRAT® 25,000 to KREON® 25,000 in the Control of Steatorrhea in Subjects Aged 7 Years and Older With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)
Forest Laboratories13 个研究点 分布在 2 个国家目标入组 87 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 13
- 主要终点
- Percent Coefficient of Fat Absorption (CFA)
研究概览
简要总结
This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000 compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).
详细描述
This is an open-label, Phase IV, multicenter, randomized, two-period cross-over study to compare the efficacy and safety of Panzytrat® 25,000 to Kreon® 25,000 in participants aged 7 years and older suffering from CF and EPI. The study consists of a qualification phase (5 to 15 days); two treatment periods of 14 days each (plus a 3-day window if needed) and a 3-day stool collection will be performed from Days 12 to 15.
A safety follow-up phone call will be arranged 7-10 days after completion of the treatment phase or after an early discontinuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant or his/her legal representative signed informed consent form (ICF) prior to starting any study procedures
- •Participant with clinical diagnosis of CF based on one or more typical clinical features of CF phenotype, in addition to one of the following: a genotype that documents the presence of 2 CF-causing mutation, or a sweat chloride test greater than or equal to 60 millimole per liter (mmol/L) by quantitative pilocarpine iontophoresis on two separate occasions
- •Participant with severe EPI confirmed by enzyme-linked immunosorbent assay (ELISA) measurement of fecal elastase-1 (FE-1)
- •Male or female participant aged 7 years or older
- •Participant currently receiving and has received a stable dose of lipase with either Panzytrat® 25,000 or Kreon® 25,000 for at least 30 days prior to ICF signature
- •Participant generally in good health, except for the underlying symptoms associated with CF and EPI, and is clinically stable (no change in the last 30 days of physical examination) as evidenced by medical and medication histories, physical examination including vital signs during screening and laboratory tests
- •Participant able to maintain a CF standardized diet with a lipid content customized to his/her needs during the study according to the qualification phase diary
- •Women of childbearing potential must have a negative pregnancy test at study entry and must use a medically acceptable contraceptive method for the duration of the study
排除标准
- •Participant with known contraindication, sensitivity or hypersensitivity to Panzytrat® 25,000 or Kreon® 25,000, or to any porcine protein
- •Participant who recently received treatment of an emergent acute infection with oral or intravenous (IV) antibiotics that was not stopped at least 14 days prior to randomization
- •Participant with chronic use of narcotics that were not stopped at least 7 days prior to the qualification visit
- •Participant using of any prohibited medications or products listed in the prohibited medication section of the protocol
- •Participant with acute pancreatitis or exacerbation of chronic pancreatic disease
- •Participant with history of significant bowel resection that could impair fat absorption
- •Participant with any condition known to increase fecal fat loss including but not limited to: celiac disease, Crohn's disease, tropical sprue, bacterial bowel infection, liver disease, lactose intolerance, pseudomembranous colitis, biliary and pancreatic cancer, radiation enteritis, Whipple's disease, Whipple's procedure, etc
- •Participant with any significant gastrointestinal dysmotility disorders
- •Participant with chronic abdominal pain or severe abdominal pain at study entry
- •Participant using enteral tube feeding over day and night
- •Participant with history or presence of clinically significant portal hypertension
- •Participant with history or presence of complete distal intestinal obstruction syndrome (DIOS) in the past 6 months, or 2 or more episodes of DIOS in the past year
- •Participant with poorly controlled diabetes as per the investigator's opinion
- •Female participants who are pregnant or breastfeeding
- •Participant with any condition or history of any illness, or pre-study laboratory abnormality which, in the opinion of the investigator or sponsor, might put the participant at risk, prevent the participant from completing the study, or otherwise affect the outcome of the study
- •Participant using any investigational drug within 30 days prior to the date of signature of the ICF
研究组 & 干预措施
Panzytrat® 25,000
Experimental
干预措施: Panzytrat® 25,000 (Drug)
Kreon® 25,000
Active Comparator
干预措施: Kreon® 25,000 (Drug)
结局指标
主要结局
Percent Coefficient of Fat Absorption (CFA)
时间窗: Day 12 up to Day 15 in first and second treatment periods
Percent CFA was calculated as (\[fat intake - fat excretion\]/fat intake)\*100, determined in the stools which were collected over a 3-day period (Day 12 to morning of Day 15) during each treatment period. Least squares mean percent (%) CFA was calculated for Day 12 to Day 15 in first and second treatment periods. Percent CFA was based on log transformed data.
次要结局
- Nutritional Status as Assessed by Electrolytes Level(Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation)
- Percentage of Participants With Abdominal Distension(Day 1 up to Day 15 in first and second treatment periods)
- Percent Coefficient of Fat Absorption (CFA) Based on Concomitant Use of Proton Pump Inhibitors (PPIs)(Day 12 up to Day 15 in first and second treatment periods)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)(Baseline up to 30 days after last dose)
- Mean Daily Number of Stools(Day 12 up to Day 15 in first and second treatment periods)
- Percentage of Stools With Normal Consistency(Day 12 up to Day 15 in first and second treatment periods)
- Total Weight of Stools(Day 12 up to Day 15 in first and second treatment periods)
- Mean Weight Per Stool Sample(Day 12 up to Day 15 in first and second treatment periods)
- Relative Frequency of Days With Abdominal Symptoms(Day 1 up to Day 15 in first and second treatment periods)
- Nutritional Status as Assessed by Body Weight(Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation)
- Nutritional Status as Assessed by Body Mass Index (BMI)(Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation)
- Nutritional Status as Assessed by Albumin, Serum Transferrin and Hemoglobin Level(Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation)
- Nutritional Status as Assessed by Hematocrit Level(Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation)
研究者
研究点 (13)
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