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Larazotide acetate in celiac disease during gluten challenge
NCT00889473Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2009
- Primary completion
- Nov 2009
- Countries
- 2
- Sponsor
- Innovate Biopharmaceuticals
- Modality
- Peptides, Small Molecules
- Drugs
- larazotide
- Conditions
- celiac disease
01
Overview
Phase 2, randomised, double-blind trial in celiac disease comparing Larazotide acetate 1 mg with Placebo (2 arms). Primary endpoint: Response to gluten at 6 weeks. Started Apr 2009; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Larazotide acetate 1 mg
Larazotide acetate 1 mg TID + Gluten 900 mg TID
Placebo
Placebo TID + Gluten 900 mg TID
03
Endpoints
Primary
Response to gluten
Secondary
Anti-transglutaminase
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