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NCT Number: NCT00775528

Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Exocrine Pancreatic Insufficiency Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Pancreatic Exocrine Insufficiency Respiratory Tract Diseases

Age range

1 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site 11, Boise, Idaho, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed Cystic Fibrosis (CF) diagnosis by two positive chloride sweat tests or gene analysis
  • Current or historical human fecal elastase < 50µg/gstool
  • Weight greater than 3.75 kg
  • Age 1 month to 6 years
  • 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

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

Treatment and study plan

Pancrelipase Delayed Release

Drug

3,000, 6,000 and 12,000 unit Lipase Capsules

Primary outcomes

  1. Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE)

    Time frame: 10 Days

    Treatment Emergent Adverse Events are defined as adverse events started at or after the first administration of study drug and include those events started prior to the first administration but which worsened after the first intake.

Secondary outcomes

  1. Stool Fat (% Fat)

    Time frame: Last 3 days in a 10-day treatment period

    The stool fat content was calculated as percent fat of dry solid weight per bowel movement. Stool fat per patient was derived as mean over three bowel movements sampled (i.e. one sample per day).

  2. Fat Intake (g)

    Time frame: Last 3 days in a 10-day treatment period

    The mean daily fat intake was determined as the average of daily fat intake over a 3-day period.

  3. Total Calorie Intake (kcal)

    Time frame: Last 3 days in a 10-day treatment period

    The total calorie intake was determined as the average of total calorie of daily food intake intake over a 3-day period.

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study title

An Open Label, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 20, 2008
Registry last updated
Nov 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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