celiac disease, gluten free diet, living without wheat, wheat-free food, coeliac sprue, gluten free dining, gluten free restaurants

I’m out of the drug trial, but here are some details

After taking my medical history at the Screening Visit, I was excluded from this drug trial, but I did learn quite a few details about the trial.

The drug being tested is the one I suspected, a zonulin antagonist developed by Alba Therapeutics and currently known as AT-1001. It is hoped that eventually, if the drug makes it to market, people with Celiac disease would be able to take this drug 3 times a day and resume eating gluten at will.

The trial is a double blind placebo controlled study. Participants and those directly caring for them will not know if they are getting a placebo or the drug.

All participants will be fed a snack or a meal duriung a 3-day hospitalization that will contain gluten. Nobody being tested or directly involved with participants will know which snack or meal contains the gluten.

2 out of each 3 participants will be getting the trial drug, 1 in 3 will get a placebo.

It is reasonable to expect that those getting the placebo who then eat gluten will react in some way, at least some of them.

Medical care will be immediately available for any patients reacting to the gluten.

If this test goes as hoped, it is estimated that it will still be 6 to 8 years until this drug could become generally available as a prescription drug.

I'll be home in another 24 hours, until then I'll not have Internet access.

This entry was posted on Saturday, December 3rd, 2005 at 11:34 pm and is filed under celiac disease. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.

3 Responses to “I’m out of the drug trial, but here are some details”

  1. Ginamos says:

    Sorry you’re out of the trial, but presumably there was good medical grounds for that decision.

    You’ve brought to my attention a physical “ailment”, I would otherwise have known nothing about. Keep up the activism.

    Have a safe journey home,

    Regards, Nick

  2. P. Campbell says:

    I had heard something about this drug. I didn’t realize they were at the trial stage.

    I don’t miss gluten-filled foods too badly, but it sure would be nice to have a pizza every once in a while:)

  3. SCHOON47 says:

    I would try the drug. but I can wait several years, not going anywhere. I do have pizza, My wife rolls out my rice bread dough on a cookie sheet, let it raise, puts on GF chicken chuncks, cheese, alfraydo sause, and other good stuff and cooks. it turns out great.
    OR you and also take your dough to Domanos and tell them to use new gloves to handle your pizza and their ingredients.