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cruelshoes

Joined: 23 Sep 2005 Posts: 2512 Location: Washington State
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Posted: Wed Nov 14, 2007 6:07 pm Post subject: AT 1001 clinical trial recruiting participants - I signed up |
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http://www.clinicaltrial.gov/ct/show/NCT00492960?order=2
For any who may be interested in being a guinea pig. If you scroll down to the bottom, you can see if there is a city near you that is participating in the study. I am putting my name on the list for sure. I want this pill!!!
| Quote: | Eligibility
Ages Eligible for Study: 18 Years - 72 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
Eligible subjects must meet all of the following criteria before being enrolled into the study:
Age between 18 and 68 years, inclusive.
Diagnosed with celiac disease for more than 6 months.
Anti-Tissue Transglutaminase (anti-tTG) less than 10 EU.
On a gluten-free diet for at least 6 months.
BMI between 18.5 and 38, inclusive.
Exclusion Criteria
Subjects meeting any one of the following criteria are not eligible for the study:
Current smoker.
Has chronic active GI disease other than celiac disease (e.g. Crohn's, Colitis).
Has diabetes (Type 1 or Type 2).
Unable to abstain from alcohol consumption for 48 hours prior to each intestinal permeability collection throughout the study.
Unable to refrain from consuming non-steroidal anti-inflammatory agents, including aspirin ("NSAIDs") for 48 hours prior to each intestinal permeability collection throughout the study.
Participated in any clinical drug study within the past 30 days or has had previous exposure to AT-1001.
Presents with or has a history of dermatitis herpetiformis. |
_________________ -Colleen
Dx 8/05 via bloodwork/biopsy
10-YO son Dx 11/05 via bloodwork/biopsy
Daughters (12 and 2) have neg. bloodwork
A woman is like a tea bag-you never know how strong she is until she gets in hot water. - Eleanor Roosevelt
Last edited by cruelshoes on Thu Nov 29, 2007 12:11 pm; edited 1 time in total |
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cruelshoes

Joined: 23 Sep 2005 Posts: 2512 Location: Washington State
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Posted: Thu Nov 29, 2007 12:09 pm Post subject: |
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I signed up for the clinical trial today. I have my first appointment next week so they can give me the once over to see if they will accept me.
The 4 groups are:
AT-1001 capsules 1 mg with 900mg gluten Drug: AT-1001 capsules, TID
AT-1001 capsules 4 mg with 900 mg gluten Drug: AT-1001 capsules, TID
AT-1001 capsules 8 mg with 900 mg gluten Drug: AT-1001 capsules, TID
Drug placebo capsules with 900 mg gluten Drug: placebo capsules, TID
I do not make this decision lightly. I know I will be exposed to some gluten. But if I can get this pill to become a reality for my son and others like him, it will be worth it. _________________ -Colleen
Dx 8/05 via bloodwork/biopsy
10-YO son Dx 11/05 via bloodwork/biopsy
Daughters (12 and 2) have neg. bloodwork
A woman is like a tea bag-you never know how strong she is until she gets in hot water. - Eleanor Roosevelt |
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aklap

Joined: 02 Oct 2004 Posts: 8542 Location: WI, USA
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Posted: Thu Nov 29, 2007 12:13 pm Post subject: |
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Interesting...
It will be interesting to see how this all works out.
The things mothers do for their children!
Good luck! _________________ Al
“We cannot all do great things, but we can do small things with great love.” Mother Teresa |
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nancw

Joined: 04 Oct 2006 Posts: 840 Location: Denver, CO
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Posted: Thu Nov 29, 2007 12:43 pm Post subject: |
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Thanks for putting yourself out there for the potential benefit of your son, and all of those w/ CD. Hopefully the actual gluten part won't be too bad for you. I'd do it, but I strike out in two ways - no dx, and I smoke. They are doing the study in Colorado Springs, too. I wonder if Dr. Lewey knows about this?
Good luck! _________________ Nance
gluten, dairy, soy, rice, yeast and 99% grain-free |
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aklap

Joined: 02 Oct 2004 Posts: 8542 Location: WI, USA
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Posted: Thu Nov 29, 2007 12:48 pm Post subject: |
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Nance, do yourself and your loved ones [yeah that includes us!] a favor and give up smoking. Please seriously consider this. Read thru the Do you Smoke thread.
Pay close attention to the story about my mother...and...on the last page of the thread the crap they put into those things. _________________ Al
“We cannot all do great things, but we can do small things with great love.” Mother Teresa |
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ostrich

Joined: 30 Mar 2006 Posts: 4145 Location: Nebraska
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Posted: Thu Nov 29, 2007 2:03 pm Post subject: |
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Darn, they're not doing it in NE. But I'll be cheering you from the sidelines Colleen! I agree: a little pain is worth the possibility of a cure (or at least some better treatment). _________________ Ostrich :>--O==={
I lie below, you float above
In the pretty white ships that I am dreaming of |
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The Edifying Conscience
Joined: 29 Aug 2005 Posts: 2427
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Posted: Thu Nov 29, 2007 4:05 pm Post subject: |
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| You're a rock star! Good luck |
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Linda
Joined: 20 Aug 2005 Posts: 399 Location: Calgary, AB, Canada
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Posted: Thu Nov 29, 2007 10:42 pm Post subject: |
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Hey! There's a study sight in Calgary. Not yet recruiting, though.
Our family can't do it because (1) Ty's only 8, and (2) the rest of us, while not smokers, are gluten eaters or also too young.
Good luck Colleen! I hope this pill works! _________________ Mom of Ty (he's eight) who was diagnosed by bloodwork June 2005, biopsy August 11, 2005, notified on & started GF August 18, 2005 |
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