Open Label Safety Study of DCI-1020 in Pediatric Cystic Fibrosis (CF) Patients

Withdrawn before enrolling · Not applicable

Conditions studied: Digestive System Diseases, Pancreatic Disease, Cystic Fibrosis, Exocrine Pancreatic Insufficiency

In brief

Hypothesis:DCI 1020 capsules are safe and effective in treating exocrine pancreatic insufficiency in CF patients \<= 2 years of age. The results of this study are intended to be submitted to the FDA as part of the NDA package for marketing approval of PANCRECARB (DCI 1020).

Key facts

Study ID

NCT00663975

Run by

Digestive Care, Inc.

People needed

24

Starts

2009-02-01

Expected to finish

2009-11-01

Last updated by the study team

2010-05-13

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female age ≤ 2 years of age
• Confirmed diagnosis of CF based on the following criteria:
• One or more clinical features consistent with the CF phenotype, AND
• Positive sweat chloride ≥ 60 mEq/liter (by pilocarpine iontophoresis), OR
• Genotype with two identifiable mutations consistent with CF
• Adequate nutritional status
• Pancreatic insufficiency documented by spot fecal elastase-1 (FE 1) greater or equal to 100 micrograms/g stool
• Clinically stable with no evidence of an acute medical condition
• Parent/Guardian able to understand and sign a written informed consent and comply with the requirements of the study

You may not qualify if…

• History of fibrosing colonopathy
• History of being refractory to pancreatic enzyme replacement therapy
• Solid organ transplant
• History of intra-abdominal surgery
• A current diagnosis or a history of distal intestinal obstruction syndrome (DIOS) in the past six (6) months, or 2 or more episodes of DIOS in the past twelve (12) months
• Conditions known to increase fecal fat loss including: inflammatory bowel disease , celiac disease, Crohn's disease, tropical Sprue, Whipple's disease
• A known contraindication, sensitivity or hypersensitivity to porcine pancreatic enzymes
• Active liver disease with liver enzymes (alanine aminotransferase (ALT/SGPT), aspartate aminotransferase (AST/SGOT) or bilirubin ≥ 3 times the upper limit of normal
• Acute pancreatitis or acute exacerbation of chronic pancreatitis
• Antibiotic use as follows:
• Acute treatment with any systemic (oral or IV) antibiotics two (2) weeks prior to screening
• Treatment with erythromycin and unwilling to discontinue the treatment two (2) weeks prior to the screening. (azithromycin is allowed)
• Change in chronic treatment with systemic (oral and IV) antibiotics during the trial
• NOTE:
• Study patient may remain on a chronic regimen of systemic (oral or IV) antibiotics (with exception of erythromycin), if he/she started the antibiotics at least 2 weeks prior to study screening, was at his/her usual bowel pattern at the time of screening, and does not stop or change these antibiotics during the study.
• Receiving enteral tube feeding during the study
• Breast feeding during the study (expressed breast milk may be used, but not feeding at the breast)
• Expected inability to cooperate with or be non-adherent to required study procedures
• Use of narcotics
• Poorly controlled diabetes
• Participation in an investigational study of a drug, biologic, or device not currently approved for marketing, within 30 days of screening visit
• A medical condition which the investigator deems significant enough to interfere with the ability of the study patient to participate in the trial or interfering with assessment of effects of enzyme therapy on fat absorption

Where it is running

• Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.