A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to determine the safety, effectiveness, and acceptability of 2 methods of administration of EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) 3,000 lipase units capsule, a pancreatic enzyme product (PEP), in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). This study is sponsored by Aptalis Pharma (formerly Eurand).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Pancreatin; Pancrelipase

Criteria

Inclusion Criteria:

• Participants with diagnosis of CF based on the following criteria: one clinical feature consistent with CF, and either a genotype with 2 identifiable mutations known to cause CF or a sweat chloride concentration that is greater than 60 milliequivalent per liter by quantitative pilocarpine iontophoresis

• Participants who have the need for a PEP defined as monoclonal fecal elastase less than 200 microgram per gram (mcg/g) stool

• Caregiver must be willing to switch participant from their previous PEP (if any) to Zenpep®

• Participants who have a height to weight ratio target at greater than tenth percentile

• Participants who are clinically stable with no evidence of concomitant illness or acute upper or lower respiratory tract infection during the 7-day interval prior to screening and preceding accession into this clinical study

Exclusion Criteria:

• Participants who are less than 1 month old or are greater than 12 months old

• Participants with history of meconium ileus or small bowel atresia in the newborn period that required surgery

• Participants who are allergic to pork or other porcine PEPs

• Participants with any respiratory condition or other serious comorbidity (for example patent ductus arteriosus [PDA], or necrotizing enterocolitis [NEC]) that in the investigator's opinion would result in an intervention requiring hospitalization or intensive pulmonary or other treatment during the trial

• Participants with other comorbidities independent of CF that, in the investigator's opinion, would result in an inability to participate in the study or excess risk to the participant that is above the standard of care

• Participants with acute respiratory infection in the previous 14 days requiring antibiotics

• Participants who required change in antacid dose in the 7 days before screening

• Participants with administration of oral, intramuscular (IM), intravenous (IV) glucocorticoids in the 4 weeks prior to screening

• Participants with any condition that would, in the investigator's opinion, limit the participant's ability to complete the study

• Participants currently participating in or has participated in an investigational study, with the exception of observational studies, within 30 days of the screening visit