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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01100606
• Date of registration: 31/03/2010
• Prospective Registration: Yes
• Primary sponsor: Forest Laboratories
• Public title: A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age
• Scientific title: A Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF)
• Date of first enrolment: June 2010
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01100606
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Aptalis Medical Information
• Affiliation: Forest Laboratories

Key inclusion & exclusion 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



Age minimum: 1 Month
Age maximum: 12 Months
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Exocrine Pancreatic Insufficiency

Intervention(s)

Drug: EUR-1008 (APT-1008)

Primary Outcome(s)

Treatment Difference for Acceptability of Treatment [Time Frame: Baseline up to end of study (Day 21)]

Question 6 (Previous Pancreatic Enzyme Product [PEP]) [Time Frame: Baseline]

Secondary Outcome(s)

Number of Stools Categorized as Per Consistency [Time Frame: Up to Day 10 in first and second treatment periods, end of study (Day 21)]

Number of Participants With Abnormal Clinical Laboratory and Vital Signs Findings [Time Frame: Baseline up to end of study (Day 21)]

Daily Number of Stools [Time Frame: Up to Day 10 in first and second treatment periods, end of study (Day 21)]

Number of Abdominal Symptoms: Bloating [Time Frame: Up to Day 10 in first and second treatment periods, end of study (Day 21)]

Number of Abdominal Symptoms: Flatulence [Time Frame: Up to Day 10 in first and second treatment periods, end of study (Day 21)]

Number of Participants With Abnormal Findings With Respect to Oral Mucosa [Time Frame: Baseline up to end of study (Day 21)]

Number of Abdominal Pain Symptoms [Time Frame: Up to Day 10 in first and second treatment periods, end of study (Day 21)]

Number of Stools With Signs of Blood and Visible Oil or Grease [Time Frame: Up to Day 10 in first and second treatment periods, end of study (Day 21)]

Secondary ID(s)

PR-011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/04/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01100606