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

NCT00663975 | Withdrawn DMC

• 1 other identifier: DCI 07-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Digestive System Diseases; Pancreatic Disease; Cystic Fibrosis; Exocrine Pancreatic Insufficiency

Keywords

cystic fibrosis; pancreatic insufficiency; pancreatic enzymes; pediatrics

Outcome Measures

Primary Outcomes (1)

• Quantitative fecal fat content (%of fat/g of dry stool) in the spot stool samples collected over the 3 day In-home Treatment Period

  3 consecutive days

Study Arms (1)

1

EXPERIMENTAL

DCI-1020 Capsules contain an enteric-coated buffered microspheres of pancrelipase, encapsulated in clear capsules. Capsules are equivalent to 4,000 USP units of lipase

Drug: DCI 1020

Interventions

DCI 1020 DRUG

capsules (4,000 units of lipase) will be administered with meals and snacks

1

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Digestive Care, Inc.: lead

Study Sites (1)

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Digestive System Diseases; Pancreatic Diseases; Cystic Fibrosis; Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Tibor Sipos, PhD

  DCI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 17, 2008
• First Posted: April 22, 2008
• Study Start: February 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 13, 2010

Record last verified: 2010-05

Locations

US (1)