Digestive System DiseasesNCT00663975
Open Label Safety Study of DCI-1020 in Pediatric Cystic Fibrosis (CF) Patients
A study testing DCI 1020 in people with Digestive System Diseases and Pancreatic Disease, run by Digestive Care, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Digestive System Diseases, Pancreatic Disease, Cystic Fibrosis
- What is being tested?
- DCI 1020
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
About this study
Official title: An Open-Label, Multi-Center Safety and Efficacy Study of DCI-1020 in Pediatric Cystic Fibrosis Patients With Exocrine Pancreatic Insufficiency
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).
Read the 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).
- Conditions
- Digestive System Diseases, Pancreatic Disease, Cystic Fibrosis, Exocrine Pancreatic Insufficiency
- Being tested
- DCI 1020
- Keywords
- cystic fibrosis, pancreatic insufficiency, pancreatic enzymes, pediatrics
- Medical subject headings
- Digestive System Diseases, Pancreatic Diseases, Cystic Fibrosis, Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCI 1020Drug
capsules (4,000 units of lipase) will be administered with meals and snacks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: DCI 1020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative fecal fat content (%of fat/g of dry stool) in the spot stool samples collected over the 3 day In-home Treatment Period
Measured: 3 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startFeb 2009
- Primary completionAug 2009 (estimated)
- Study completionNov 2009 (estimated)
Why it stopped: Study not being conducted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Digestive Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tibor Sipos, PhD, Study director, DCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663975
- Sponsor's protocol ID
- DCI 07-001
- Status last verified
- May 2010
- First submitted
- 17 Apr 2008
- Last updated
- 13 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center Safety and Efficacy Study of DCI-1020 in Pediatric Cystic Fibrosis Patients With Exocrine Pancreatic Insufficiency
- ClinicalTrials.gov ID
- NCT00663975
- Acronym / sponsor ID
- DCI 07-001
- Conditions
- Digestive System Diseases, Pancreatic Disease, Cystic Fibrosis, Exocrine Pancreatic Insufficiency
- Keywords
- cystic fibrosis, pancreatic insufficiency, pancreatic enzymes, pediatrics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not being conducted
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Digestive Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DCI 1020DCI-1020 Capsules contain an enteric-coated buffered microspheres of pancrelipase, encapsulated in clear capsules. Capsules are equivalent to 4,000 USP units of lipase |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCI 1020capsules (4,000 units of lipase) will be administered with meals and snacks | Drug | 1 |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tibor Sipos, PhD study director
DCI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DCI 1020 in people with Digestive System Diseases and Pancreatic Disease, run by Digestive Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2010.