CompletedPhase 2
A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Celiac Disease
Key facts
- Who runs it
- Igy Inc.
- Where
- Canada2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 161 people enrolled
- Started
- 29 Oct 2019
- Ended
- 31 Dec 2023
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- AGY
- placebo
- Record updated
- 6 March 2024
Who can take part
- Age
- 10 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- history of CD
- experience periodic celiac related symptoms
- following a gluten free diet for at least 12 months
Who cannot take part
- severe complications of CD or chronic active GI disease
- any condition that in the opinion of the investigator, would preclude safe participation
- type 1 diabetic
- pregnant or breast feeding
- daily ASA/NSAID use
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
To assess the efficacy and safety of AGY vs placebo when administered to individuals age 10 to 65 years with medically proven CD and on a gluten free diet
The 2 groups in the trial
- AGYTreatment being tested
capsule containing egg yolk with AGY
- placeboPlacebo, for comparison
capsule containing plain egg yolk
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Crossover Trial to Evaluate Safety and Efficacy of AGY in Persons With Celiac Disease Age > 10 Years
- Record updated
- 6 March 2024