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

This study has been withdrawn prior to enrollment.
(Study not being conducted)
Sponsor:
Information provided by:
Digestive Care, Inc.
ClinicalTrials.gov Identifier:
NCT00663975
First received: April 17, 2008
Last updated: May 12, 2010
Last verified: May 2010
  Purpose

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).


Condition Intervention
Digestive System Diseases
Pancreatic Disease
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Drug: DCI 1020

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Center Safety and Efficacy Study of DCI-1020 in Pediatric Cystic Fibrosis Patients With Exocrine Pancreatic Insufficiency

Resource links provided by NLM:


Further study details as provided by Digestive Care, Inc.:

Primary Outcome Measures:
  • Quantitative fecal fat content (%of fat/g of dry stool) in the spot stool samples collected over the 3 day In-home Treatment Period [ Time Frame: 3 consecutive days ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: February 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
capsules (4,000 units of lipase) will be administered with meals and snacks

Detailed Description:

A large body of data supporting the safety and efficacy of PANCRECARB® (pancrelipase) Capsules is available in patients above age 2. This study is being performed to gather the data to demonstrate the safety and efficacy of DCI1020 in pediatric CF patients (≤ 2 years) with exocrine pancreatic insufficiency. This study also takes into consideration an "age appropriate" dosing form. Specifically, the enzymes will be administered orally by opening the capsules and emptying the microspheres into a small amount of applesauce as an example of a slightly acidic soft food such as jelly, jello, etc. for feeding.

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(pancrelipase).

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663975

Locations
United States, Ohio
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Digestive Care, Inc.
Investigators
Study Director: Tibor Sipos, PhD DCI
  More Information

No publications provided

Responsible Party: William Humphries, Digestive Care Inc
ClinicalTrials.gov Identifier: NCT00663975     History of Changes
Other Study ID Numbers: DCI 07-001
Study First Received: April 17, 2008
Last Updated: May 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Digestive Care, Inc.:
cystic fibrosis
pancreatic insufficiency
pancreatic enzymes
pediatrics

Additional relevant MeSH terms:
Cystic Fibrosis
Digestive System Diseases
Gastrointestinal Diseases
Fibrosis
Pancreatic Diseases
Exocrine Pancreatic Insufficiency
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014