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Tracking Information | |||||||||
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First Received Date ICMJE | June 8, 2011 | ||||||||
Last Updated Date | June 5, 2012 | ||||||||
Start Date ICMJE | May 2011 | ||||||||
Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Growth velocity in grams per kilogram per day during 4 weeks of treatment. [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01413581 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants | ||||||||
Official Title ICMJE | A Prospective, Randomized, Double-Blind, Phase 3 Study Comparing rhBSSL and Placebo Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants Born Before Week 32 of Gestational Age | ||||||||
Brief Summary | The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo. |
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Detailed Description | The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo. The infants should be born before week 32 of gestational age. The study drug, rhBSSL or placebo, will be administered during a 4 week treatment period by adding it to either infant formula or pasteurized breast milk. The study will also evaluate the safety and tolerability of rhBSSL. Eligible patients will be randomized in a ratio of 1:1 (rhBSSL:placebo). The study consists of maximum 1 week screening period, a 4-week treatment period and a 1 year follow-up period. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Prevention of Growth Restriction | ||||||||
Intervention ICMJE | Drug: rhBSSL (recombinant human bile-salt-stimulated lipase)
rhBSSL or placebo added to infant formula/pasteurized breast milk during a 4 week treatment period. |
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Study Arms |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 432 | ||||||||
Estimated Completion Date | August 2013 | ||||||||
Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | up to 10 Weeks | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, Russian Federation, Spain, Sweden, United Kingdom | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01413581 | ||||||||
Other Study ID Numbers ICMJE | BVT.BSSL-030 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | Swedish Orphan Biovitrum | ||||||||
Study Sponsor ICMJE | Swedish Orphan Biovitrum | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | Swedish Orphan Biovitrum | ||||||||
Verification Date | June 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |