A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo (EDIT)
Tracking Information
Start Date ICMJE | June 2009 |
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Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: June 10, 2009) | Relative change from baseline FEV1 percent predicted compared to placebo [ Time Frame: Day 29 of on-treatment period of cycle 1 ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00918957 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: June 10, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo |
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Official Title ICMJE | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew). |
Brief Summary | This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment |
Condition ICMJE | Cystic Fibrosis |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 100 | ||||
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Estimated Completion Date | February 2010 | ||||
Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply | ||||
Gender | Both | ||||
Ages | 6 Years to 21 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Estonia, Latvia, Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00918957 | ||||
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Responsible Party | External Affairs, Novartis Pharmaceuticals | ||||
Study ID Numbers ICMJE | CTBM100C2303, EudraCT 2008-002318-22 | ||||
Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Novartis |
Source: http://clinicaltrials.gov/