Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)
Overview
This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 – 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.
Full Title of Study: “A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 12,000 Unit Capsules in Subjects Aged 7 – 11 With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: December 2008
Interventions
- Drug: Pancrelipase Delayed Release
- 12,000 unit Capsules, dosed individually based on fat intake.
- Drug: Placebo Comparator
- Placebo
Arms, Groups and Cohorts
- Experimental: A
- Placebo Comparator: B
Clinical Trial Outcome Measures
Primary Measures
- 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.
Secondary Measures
- 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 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.
- 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.
Participating in This Clinical Trial
Inclusion Criteria
- Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis – Confirmed PEI by historical Coefficient of fat Absorption < 70% without supplementation or current or historical fecal elastase < 50µg/stool (within the last 12 months) – 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 – Stable body weight and agrees to abstain from sexual activity Exclusion Criteria:
- Ileus or acute abdomen – History of fibrosing colonopathy, celiac disease, gastrectomy, Crohn´s disease and small bowel surgery other than minor resection due to meconium ileus without resulting in malabsorption syndrome – 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
Gender Eligibility: All
Minimum Age: 7 Years
Maximum Age: 11 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Solvay Pharmaceuticals
- Provider of Information About this Clinical Study
- Djenane Bennett, Solvay Pharmaceuticals
- Overall Official(s)
- Global Clinical Director Solvay, Study Director, Solvay Pharmaceuticals
Citations Reporting on Results
Graff GR, Maguiness K, McNamara J, Morton R, Boyd D, Beckmann K, Bennett D. Efficacy and tolerability of a new formulation of pancrelipase delayed-release capsules in children aged 7 to 11 years with exocrine pancreatic insufficiency and cystic fibrosis: a multicenter, randomized, double-blind, placebo-controlled, two-period crossover, superiority study. Clin Ther. 2010 Jan;32(1):89-103. doi: 10.1016/j.clinthera.2010.01.012.
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