Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
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ClinicalTrials.gov Identifier: NCT00510484 |
Recruitment Status :
Completed
First Posted : August 2, 2007
Results First Posted : July 20, 2009
Last Update Posted : June 3, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cystic Fibrosis | Drug: Pancrelipase Delayed Release Drug: Placebo Comparator | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 24,000 Unit Capsules in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | March 2008 |
Actual Study Completion Date : | March 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: A |
Drug: Pancrelipase Delayed Release
24000 unit Capsule |
Placebo Comparator: B |
Drug: Placebo Comparator
Placebo |
- Coefficient of Fat Absorption (%) [ Time Frame: 5 days ]This coefficient is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.
- Coefficient of Nitrogen Absorption (%) [ Time Frame: 5 days ]This coefficient is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.
- Total Fat Excretion (Grams) [ Time Frame: 5 days ]Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.
- Total Stool Weight (Grams) [ Time Frame: 5 days ]Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.
- Stool Frequency [ Time Frame: 5 days ]Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.
- Percentage of Days With no Flatulence. [ Time Frame: 5 days ]The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response.
- Percentage of Days With no Abdominal Pain. [ Time Frame: 5 days ]The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response.
- Percentage of Days With Formed/Normal Stools. [ Time Frame: 5 days ]The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response.

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
- Confirmed PEI by historical CFA < 70% without supplementation or current or historical fecal elastase < 50µg/g stool (within the last 12 months)
- Subjects of 12 years or older
- Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months
- Clinically stable condition without evidence of acute respiratory disease or any other acute condition
- Females of child-bearing potential must agree to continue using a medically acceptable method of birth control
Exclusion Criteria:
- Ileus or acute abdomen
- History of fibrosing colonopathy
- History of distal ileal obstruction syndrome within 6 months of enrollment
- Use of an immunosuppressive drug
- Any type of malignancy involving the digestive tract in the last 5 years
- Known infection with HIV

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 ClinicalTrials.gov identifier (NCT number): NCT00510484

Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
Responsible Party: | Djenane Bennett, Solvay Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00510484 |
Other Study ID Numbers: |
S245.3.126 2007-004005-10 |
First Posted: | August 2, 2007 Key Record Dates |
Results First Posted: | July 20, 2009 |
Last Update Posted: | June 3, 2010 |
Last Verified: | August 2009 |
Pancreatic exocrine insufficiency Cystic Fibrosis |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pancrelipase Pancreatin Gastrointestinal Agents |