Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)
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|ClinicalTrials.gov Identifier: NCT00408317|
Recruitment Status : Completed
First Posted : December 6, 2006
Results First Posted : March 12, 2014
Last Update Posted : March 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Exocrine Pancreatic Insufficiency||Drug: Ultrase® MT20 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Crossover Study to Compare the Safety and Efficacy of Ultrase® MT20 to Placebo for the Correction of Steatorrhea in Patients With Cystic Fibrosis (CF)|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
U.S. FDA Resources
|Experimental: Ultrase® MT20||
Drug: Ultrase® MT20
Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
Other Name: Pancreatic enzyme product
|Placebo Comparator: Placebo||
Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
- Percent Coefficient of Fat Absorption (CFA) [ Time Frame: Day 3 to Day 7 in first intervention period and second intervention period ]Percent (%) CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined by the stools collected during the 72-hour period which could extend to 96 hours during both intervention periods. Mean CFA percent was calculated for 72-hour/96-hour period during Day 3 to Day 7 in the first and second intervention periods.
- Percent Coefficient of Nitrogen Absorption (CNA) [ Time Frame: Day 3 to Day 7 in first intervention period and second intervention period ]Percent (%) CNA was calculated as [(nitrogen intake-nitrogen excretion)/nitrogen intake]*100, determined by the stools collected during the 72-hour period which could extend to 96 hours during both intervention periods. Nitrogen intake was calculated as protein intake/6.25. Mean percent CNA was calculated for 72-hour/96-hour period during Day 3 to Day 7 in the first and second intervention periods.
- Number of Bowel Movements [ Time Frame: Day 3 on first intervention period and second intervention period ]Number of bowel movements of each participant was calculated from frequency of stools by the participant per day. Mean daily number of bowel movements on Day 3 for the first treatment period and second treatment period was summarized.
- Percentage of Stool Categorized by Consistency [ Time Frame: Day 4 on first intervention period and second intervention period ]Stool consistency was categorized as hard, formed/normal, soft or watery stool. Percentage of stools of a specific consistency of each participant was calculated as the number of stools with a specific consistency relative to the total number of stools during the collection period. Mean percentage of stool with specific consistency on Day 4 for the first treatment period and second treatment period period for total participants was summarized.
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): NCT00408317
|United States, Michigan|
|DeVos Children's Hospital|
|Grand Rapids, Michigan, United States, 49503|
|United States, Ohio|
|Rainbow Babies & Children's Hospital|
|Cleveland, Ohio, United States, 44106|
|United States, Pennsylvania|
|Pennsylvania State University, The Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|United States, Utah|
|University of Utah Health Sciences Center|
|Salt Lake City, Utah, United States, 84112|
|Study Director:||Aptalis Medical Information||Forest Laboratories|