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LisaBulman

Finished another study today (DISTOL)

15 posts in this topic

Today was my final visit for the Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine (DISTOL-1).This study will evaluate the effect of treprostinil diethanolamine (UT-15C) sustained release tablets(compared to placebo) on digital ulcers in patients with scleroderma. Started May 2009. ClinicalTrials.gov. (Also see: Scleroderma Treatments and Clinical Trials and Digital Ulcers)

It was also my first day of enrolling in the extension part of the study. Honestly, I believe that I had the placebo (as usual) but will know soon for sure. After 20 weeks of the study I was taking 16mgs, twice a day. I had no side effects whatsoever. Today I am going to start taking less of the meds and by Monday I will be on the actual drug starting at .25mgs. If it is tolerated well then after 72 hours I will bump it up to .50mgs. Hopefully by the middle of next week I will have a better idea if I had the actual drug or the placebo. If it was the actual drug, it didn't work. I had three ulcers develop while I was in the study. Fingers crossed!!

Hugs,
Lisa


Lisa Bulman

(Retired) ISN/SCTC List Coordinator

(Retired) ISN Sclero Forums Assistant Manager

(Retired) ISN Assistant News Guide

(Retired) ISN Fundraiser

International Scleroderma Network (ISN)

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Lisa,

 

First let me say THANKS for doing it again! You are one brave soul and a good soul that we all appreciate! So how many clinical trials does this make for you and out of those, how many times have you actually received the drug being tested and not the placebo? If I remember correctly - zip :emoticon-bang-head:

 

The fact that you developed 3 more ulcers sure doesn't say much for the drug if you were actually on it. It does sound like the placebo yet again. Hopefully, once you do get on it, I sure hope it works for you! Those digital ulcers just don't seem to give you a break at all.

 

Please let us know what you find out. Thanks again!


Janey Willis

ISN Support Specialist

(Retired) ISN Assistant Webmaster

(Retired) ISN News Director

(Retired) ISN Technical Writer for Training Manuals

International Scleroderma Network (ISN)

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Thanks, Lisa! Without people like you volunteering for studies, there'd be no progress at all. I hope that once you are on the 'real' drug that it works wonderfully well for you.Warmest wishes,


Jeannie McClelland

(Retired) ISN Director of Support Services

(Retired) ISN Sclero Forums Manager

(Retired) ISN Blog Manager

(Retired) ISN Assistant News Guide

(Retired) ISN Artist

International Scleroderma Network

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Lisa, I'm thrilled that you are enrolled in the extension of the study now. Great big hugs to you for participating in clinical trials and helping to advance treatments for scleroderma.

 

We ALL appreciate it! I just hope you finally get the real stuff, and that it works for you, too.

 

:thank-you:


Warm Hugs,

 

Shelley Ensz

Founder and President

International Scleroderma Network (ISN)

Hotline and Donations: 1-800-564-7099

 

The most important thing in the world to know about scleroderma is sclero.org.

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This was actually my fourth study and Janey you are correct....zip!! (love the bunny!!! It is exactly how I feel)I have received the placebo in all of them. I start the real drug on Monday night so we'll see how that goes! Since I did develop the ulcers I was hoping it was the placebo because otherwise the drug stinks. Well that's what my dr said anyway but he used a harser term than stinks. :)

 

I'll keep you all posted! YOU ARE WELCOME!!!!

 

Hugs,

Lisa


Lisa Bulman

(Retired) ISN/SCTC List Coordinator

(Retired) ISN Sclero Forums Assistant Manager

(Retired) ISN Assistant News Guide

(Retired) ISN Fundraiser

International Scleroderma Network (ISN)

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Congratulations again Lisa for following through with yet another trial!

 

Sure hope that new drug works....since you're finally going to get to actually try it! Good luck!


Sending good wishes your way!

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Thanks, Lisa, for the latest update and also for all that you do to help everyone!

 

Hugs,

 

warmheart :flowers:

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I have discovered that I was on the placebo. No big shock! Last Friday I started with some leg pain, more like achy and cramping along with a headache. I brushed it off to being exhausted. Monday morning at about 3am I woke up because my jaw was in awful pain, almost like someone punched me. I got out of bed and took something for the pain. As usual I took my morning dose and the jaw pain came back along with the achy legs. The study coordinator called me to check in and when I explained to her what I was experiencing she said they were side effects of the meds. I am currently on .75mgs of the real med. During the double blind portion of the study I finished at 16mgs with no side effects. Well at least I am consistent with getting the placebo every time!!

 

Hugs,

Lisa


Lisa Bulman

(Retired) ISN/SCTC List Coordinator

(Retired) ISN Sclero Forums Assistant Manager

(Retired) ISN Assistant News Guide

(Retired) ISN Fundraiser

International Scleroderma Network (ISN)

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Lisa,

 

How wonderful to wake up and see a post from you. I was unable to sleep last night due to a headache, and for some reason I was thinking of you! I hadn't seen a post from you in awhile and I was going to email this morning to check in with.

 

You are one brave soul doing all of these studies, and we sure do appreciate it!


Warm and gentle hugs,

 

Pamela

ISN Support Specialist

International Scleroderma Network (ISN)

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Hi Lisa,

 

Well, doesn't that just figure, that you got the placebo first round -- again!

 

I'm delighted you are having side effects from the meds because maybe it means that it is actually doing something -- hopefully something positive, at the same time. Hang in there!

 

Here are some clinical trial flowers just for you: :flowers:


Warm Hugs,

 

Shelley Ensz

Founder and President

International Scleroderma Network (ISN)

Hotline and Donations: 1-800-564-7099

 

The most important thing in the world to know about scleroderma is sclero.org.

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