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Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants

NCT01413581 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 415

Last updated 2015-07-30

No results posted yet for this study

Summary

The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo.

Conditions

  • Prevention of Growth Restriction

Interventions

DRUG

rhBSSL (recombinant human bile-salt-stimulated lipase)

rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.

DRUG

Placebo

Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.

Sponsors & Collaborators

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Principal Investigators

  • Kristina Timdahl, MD · Swedish Orphan Biovitrum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-07-31
Completion
2014-08-31

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Russia
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01413581 on ClinicalTrials.gov