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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00663975
Recruitment Status : Withdrawn (Study not being conducted)
First Posted : April 22, 2008
Last Update Posted : May 13, 2010
Information provided by:
Digestive Care, Inc.

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).

Condition or disease Intervention/treatment Phase
Digestive System Diseases Pancreatic Disease Cystic Fibrosis Exocrine Pancreatic Insufficiency Drug: DCI 1020 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2009
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
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

Primary Outcome Measures :
  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 [ Time Frame: 3 consecutive days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00663975

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United States, Ohio
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Digestive Care, Inc.
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Study Director: Tibor Sipos, PhD DCI
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Responsible Party: William Humphries, Digestive Care Inc Identifier: NCT00663975    
Other Study ID Numbers: DCI 07-001
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: May 13, 2010
Last Verified: May 2010
Keywords provided by Digestive Care, Inc.:
cystic fibrosis
pancreatic insufficiency
pancreatic enzymes
Additional relevant MeSH terms:
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Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Digestive System Diseases
Gastrointestinal Diseases
Pancreatic Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases