A Study to Compare US Marketed Pancrelipase Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis.
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03924947|
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : January 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: Pancrelipase||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 4 Study to Compare US Marketed Creon Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing Site, in Subjects With Exocrine Pancreatic Insufficiency (EPI) Due to Cystic Fibrosis|
|Actual Study Start Date :||October 23, 2019|
|Estimated Primary Completion Date :||July 18, 2020|
|Estimated Study Completion Date :||February 22, 2021|
Experimental: Arm A
Participants will receive Pancrelipase delayed release (DR) Capsules manufactured by modernized process uniform coated pellets (MP) in treatment period 1, followed by currently marketed Pancrelipase DR Capsules in treatment period 2.
Delayed release capsules
Experimental: Arm B
Participants will receive currently marketed Pancrelipase delayed release (DR) Capsules in treatment period 1, followed by Pancrelipase DR Capsules manufactured by modernized process uniform coated pellets (MP) in treatment period 2.
Delayed release capsules
- Coefficient of Fat Absorption (CFA) [ Time Frame: Up to Week 6 post randomization ]
CFA is calculated as 100*[fat intake - fat excretion]/fat intake.
Fat intake will be determined from fat content of food consumed. Fat excretion will be determined from the fat content in the stool(s) collected between the two dye markers.
- Stool fat [ Time Frame: Up to Week 6 post randomization ]Total amount of fat excreted during the stool collection period.
- Coefficient of Nitrogen Absorption (CNA) [ Time Frame: Up to Week 6 post randomization ]The CNA is calculated as 100*[nitrogen intake - nitrogen excretion]/nitrogen intake.
- Stool weight [ Time Frame: Up to Week 6 post randomization ]Stool weight is assessed by weighing the stool(s).
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): NCT03924947
|Contact: ABBVIE CALL CENTERemail@example.com|
|United States, California|
|Usc /Id# 164571||Not yet recruiting|
|Los Angeles, California, United States, 90033|
|Landon Pediatric Foundation /ID# 215411||Not yet recruiting|
|Ventura, California, United States, 93003-3099|
|United States, Florida|
|Nemours Childrens Specialty Ca /ID# 164553||Recruiting|
|Jacksonville, Florida, United States, 32207|
|Central FL Pulmonary Orlando /ID# 164558||Recruiting|
|Orlando, Florida, United States, 32803|
|United States, Georgia|
|Children's Healthcare of Atlanta - Ferry Rd /ID# 213433||Not yet recruiting|
|Atlanta, Georgia, United States, 30342-1605|
|United States, Illinois|
|Chicago Pulmonary Specialists /ID# 210757||Recruiting|
|Glenview, Illinois, United States, 60025-7645|
|United States, Iowa|
|University of Iowa Hospitals and Clinics /ID# 164551||Recruiting|
|Iowa City, Iowa, United States, 52242|
|United States, Kansas|
|Via Christi Research /ID# 214266||Recruiting|
|Wichita, Kansas, United States, 67214-2878|
|United States, Ohio|
|Cleveland Clinic Main Campus /ID# 212853||Not yet recruiting|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Children's Hosp of PA (CHOP) /ID# 208114||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104-4399|
|United States, Tennessee|
|Vanderbilt Univ Med Ctr /ID# 213434||Not yet recruiting|
|Nashville, Tennessee, United States, 37232-0011|
|United States, Virginia|
|Virginia Commonwealth Univ /ID# 164574||Recruiting|
|Richmond, Virginia, United States, 23219|
|Hospital Univ Vall d'Hebron /ID# 165112||Not yet recruiting|
|Barcelona, Spain, 08035|
|Hosp Infantil Univ Nino Jesus /ID# 213460||Not yet recruiting|
|Madrid, Spain, 28009|
|Study Director:||AbbVie Inc.||AbbVie|