NIDDK/ICCRN Announces New Study of Elavil in Treating IC

[icnmgrjill]

Yes, the long awaited announcement for the next federally funded IC clinical trial was made last week! They will be studying (sigh!) amitryptiline (Elavil) to determine its effect in reducing the symptoms of IC and/or painful bladder syndrome. Ten research centers across the USA are currently looking for patients to participate. Read about it... and review the research center locations and contact information at:

http://www.ic-network.com/clinicaltrials/2005niddk.html

[greghh]

It's good to see a new research trial on IC, though I am disappointed that amitryptilene is the focus. I take 50mg of amitryptilene a night and it has greatly helped my symptoms. From what I've been able to gather, amitryptilene is a staple for treating IC and there are several studies already that indicate its efficacy, especially the recent placebo controlled study in Germany. I wish the U.S. government would get out in front to find new medications to help IC patients, and not repeat research that has largely been done.

Greg Henderson
Indiana

[theclownster]

Thanks for sharing the good news. I am currently taking Elavil, so I can't be a part of the study. I was suprised to see that there are two Michigan research locations, one of which is within the health system that I work. I plan to call the research coordinators and thank them for their efforts. I might also email them with my applause and offer to help in any way I can even though I'm not eligible for the study. I get pretty groggy from the elavil and it's a much lower dose than what they are using in the study. I hope that does not effect the drop out rate of the study.

Thanks for always keeping us informed Jill. It's great to know what is going on in the world of ICer's.

Warm regards~
Jennifer

[jrowley]

Oh i see one is in detroit it would be grand if I could participate in it but I can't take elavil with my mirapex that I take for my rls. :(

[kadi]

Hasn't this already been done?
(Kind of disappointing, I've been helped by Elavil, but can only tolerate 20mg of it, so can't rely on it for complete symptom relief...)

[SharonA]

Jill...I understand why you included a "sigh" in your post about this. This is old information. Why are they wasting the money researching something that we already know about? My gosh, I have been on it for 3 years!!! It was the first med my doctor prescribed the first time I saw her after my diagnosis and she was not that knowledgable about IC at the time.

I guess the best thing about them studying Elavil is that those in the test who are not on it and get the med, not the placebo, will be able to get it for free for awhile.

I do question the dosage amount, though. Personally, I think 75mg is way to high of a dose to take for that length of time. Oh well, I guess that is why I am not a research scientist. What do I know. :rolleyes:

:idea:...hey Jen (Sarojini)...why not see if they would hire a research scientist to be on the team who has actual experience dealing with IC. Send that resume' right on out to them, girlfriend. Couldn't hurt... ;)

[darlene]

Double sigh! Using limited research money to study elavil, is a waste! It's been around for years. That money should be used to develop new, more effective drugs!

[sleepyangel30]

Yep it's just a waste of money :(

[mayray518]

I agree. Elavil is one of the first things uros who know anything about IC prescribe and thank God for that because it saved my life. But use the money to study new drugs that will work for IC; perhaps they could discover a generic elavil without the side effects.

[classics]

Seems like Elavil is another drug that just masks the symptoms, not work towards the cure.

[Betsie]

Does anyone here know the criteria that establishes such a study? I mean why elavil and what control group was instrumental in choosing it. How are funds decided on and where in fact are they generated from. Are the makers of elavil (brand name) a partner to this study?? I am suddenly full of questions, as I have never thought much of studies and how they are established. Though any study of IC is at least an aknoweldgement...yes??

I took elavil long before IC for migraines and again as combo form with lithium for spastic colon...though the drug is an antidepressant by definition. So, like others here have pointed out, it is interesting ~ why now? I would also be curious as I can't function on it even at low doses, though for pain relief meds I have the opposite problem. I have not met too many people that take this for reasons other than depression (which is usually rxd at high doses) that can tolerate high amounts either.

Jill, it must be exhausting to keep up with all of this info. I also wonder how exact these study groups are in the end, and what criteria might it establish for future treatment of IC? Some Drs are so oblivious to the world of IC, that just seeing a report that IC responds well to elavil therapy...makes me nervous that they would see this as the be all in rx treatment. Sorry to be rambling, all these posts have let my mind go off. I guess it concerns me that if they do establish a high protocol Elavil use for IC, that in many Drs mind it will only confirm what they always thought anyway...that it is an emotional disease. :rolleyes: :mad:

[darlene]

Jill, is there any way we can let those in charge know how displeased we are with this study? The people who decide where the money goes, don't always really understand this disease. IC research funds are very limited compared to those for other diseases. We can't waste a cent! I would have been much happier to see the money go to the Dr. Keay's study of APF. That would have been progress. Is it too late to try to halt this terrible study?

[theclownster]

Hi everyone! I can understand everyone's disappointment in this particular study, but I also think it's important to acknowledge the positive efforts of all researchers interested in helping us. To play a little bit of devil's advocate, Elavil is not currently FDA approved to treat IC. To my understanding, the only medication FDA approved to treat IC is Elmiron. Elavil has been known to help, but there may not be sufficient research to justify these claims. Additional reasearch may help increase awareness for Doctors who don't routinely use this as part of their IC treatment. You never know what kinds of doors this research could open.

I'm sure we all have ideas of what might be better research. At this point, I'm choosing to be thankful that they are researching treatment methods for IC period. I called the research coordinator at the Detroit location today and left a message thanking them for their efforts. I shared that I was not a candidate for the study but if they needed my help, I'd be more than happy to give. I do question the dosage of 75mg - as that seems a bit high to me - but who knows, maybe they will discover something different with this one.

I will continue to hope that research will continue on the treatment of IC.
Jennifer

[melanie626]

:) I agree with Jill, getting it on the FDA list will help in terms of meds for IC. What we must understand is many meds are used off lable and this now gives it an idication to use by FDA standards.

This is more positive then you know...because of several reasons. The first is that word got out, that this old antidepressent helped with pain (an example of side effects being positive in a way). More and more MD's listened and have been prescribing it. Doing a study gives the drug affirmation of this and use for this disease.

Although not a huge bit of new news to us now (makes me totally hung over), it will lead others who may notice that drug X causes X<Y<Z side-effect- and maybe one of those docs will be smart, see one of us, turn on the old light bulb, and it ends up being something that could really help IC......start spreading the word....all the sudden tons of IC patients are now on a different drug, it may help enourmously but lets say it was origionally made for people with cardiac disease.....less educated docs aren't going to feel as comfortable giving it...blah, blah...see how this can be a positive?

Those are my thoughts, thanks for letting me share

[theclownster]

I just wanted to let everyone know that the researcher at the Detroit location called me back - I was out of my office so she left me a voicemail. She sounded very pleased that I called her and she wanted me to know that the voicemail was very nice to hear as she started her day. She sounded surprised that I was thanking them. I just wanted to share this with everyone, because I think the more researchers know they are appreciated, the more they might do for us. It's always good to get good feedback for their efforts.

Jennifer

[Red Hatter]

I would have a bad bad flare if i didnot take elavil. Thank God for it.

[ads]

This is a waste of our tax dollars! Maybe we should start a call in to the government!?!

ads

[windwalker]

I had no idea where to put this so I hope here is ok, I got this in my alerts thought I'd pass it on. Its a cut n paste from here: http://www.centerwatch.com/patient/studies/stu70580.html

Trial Information

Summary: Painful bladder syndrome/interstitial cystitis: A clinical trial to evaluate the effectiveness of a medication for the treatment of painful bladder symptoms in newly diagnosed patients.
The cause(s) of interstitial cystitis and painful bladder syndrome are not known, and currently there is no permanent cure; treatment is mostly experimental and aimed to treat the bothersome symptoms. The Painful Bladder Study is for men and women who are newly diagnosed with either of these conditions.

If you qualify for this study, you will be asked to come to William Beaumont Hospital in Royal Oak, Michigan, for 5 clinic appointments over 12-14 weeks, take a daily medication, and follow an educational/ lifestyle program. All visits, medications, and blood and urine tests are provided at no cost to you or your health insurance provider.

Study Criteria:

Must be at least 18 years old.
Must have increased day time and night time urinary frequency (have to urine more often than normal).
Must have lower abdominal/pelvic pain that occurs when the bladder is full.
Must not currently have a urinary tract infection.
For more information,

Contact:

Eleanor Anton, RN, CCRC, Research Nurse Clinician
William Beaumont Hospital
3535 W. 13 Mile Road, Suite 432
Royal Oak, MI 48073
Telephone: 248-551-0885
Fax: 248-551-5378
Email: eanton@beaumont.edu

[Julie B]

For those who question, I talked to one of the uro staff members who will be involved with one site of this study. I think the study is to see if they can use elavil to arrest the IC if it is caught early enough. That would be a blessing for those who are newly diagnosed.........

[aerheart]

I have also been on Elavil since I was diagnosed 5 years ago, and I am lucky in being able to tolerate it and still function. I have just completed my own test by going without Elavil - just 5 days and I'm in a lot of pain even though my recent cysto showed the bladder looking a lot better. So I guess I will go back on it. It doesn't totally take away the pain but takes it down a notch so that I can work. A lot of the pain management centers have been advocating its use for migraines and ic pain. I just hope someone will come up with some type of cure instead of rehashing a drug which has already been studied.

[JaniceB]

I'm so excited about this. I have had IC symptoms for 5 months, and a uro who told me I had "an inflammed bladder wall" (dx through a very painful in-office cysto) but wouldnt give me anything for it, except OAB medication! (which doesnt do a thing for it)

So when I discovered this study, a little more than an hour away from me, I was thrilled!!

I am going for my first appt Tues. The reason I am so excited, these are the first people to listen to ME and they will HELP me either way with this.

I realize for people who have struggled with this for ages this isnt the type of thing they want to see, but please understand how important it is for someone like me. Yes, it is geared more to people with newly found cases of IC - part of it is trying to establish where it comes from in the first place, which is important.

I've been told I'm a very good candidate from the screening questions I answered, so am keeping my fingers crossed the first screening appt goes well (physical, etc). I'm excited that I will be seeing some of the best doctors around - for free.

Is anyone else participating? Would love to know!

[icsonja]

Congrats to Janice, we all have to try to remember how excited we were when we finally got someone to listen to us and give us some treatment. for her that is this study, be happy for her and all the others this study will help, anyway we don't know that this study might just help the rest of us someday,Baby steps yes, but they are going FORWARD.
I took elavil for 3 years, going off in Jan when I had the stim put in, I was up to 150mg daily,I gained some weight (which I needed) and I craved sweets. It did help w/ pain and some w/ anxiety. I will be intrested in knowing more about thid med and how it may be of better use to us.
I know Jill it must be so hard on you especially as you work so hard for funding, but we are getting somewhere!!When I first was DX'd 6years ago there were no trials for IC except I believe Elmiron, now I get Centerwatch notifacations almost weekly about new trials, studies for IC or CPP (chronic pelvic pain) or IBS and IC together.
Just keep applying to all you can get into, I think that motivates researchers to continue to try to find the answer we all seek
I have applied to several trials and didn't fit protocol. but I did like the post earlier did, I thanked them for doing the trial. and voluntereed myself for any questions they may have about living w/ IC and CPP and IBS, well the whole alpahbet soup of IC stuff..lol
Keep on keeping on right? Keep chins up and keep seeking better treatment, we can do it. It is up to US to push those who need a shove(gentle) for ,money for research.
OK that will conclude Sonja's Sermon of the Day (the crowd roars)

[Janie Miranda]

When I first read this I was also a bit disapointed that research funds were being used to study a medicine that most consider tried and true to be helpful in IC but from my own experience I've found that doctors won't neccessarily use Elavil for IC (even when you ask for it) so I'm actually now grateful they are doing the study. Hopefully there will be difinitive proof that it is helpful for the condition and some doctors who don't prescribe it will start doing so - also if there is scientific studies to show it works maybe it will encourage patients who have been reluctant to try it to begin using it.
By the way does anyone know when the study will end and the results will be published?

[JaniceB]

You're correct, part of the study it, they are trying to get it APPROVED as an IC drug (using people who have recenlty been onset with IC) since apparently right now it is only approved for depression.

I just started the study medication Tues. At first I didnt notice much, but I've felt better the past 2 days as far as my pain. I'm only on 10mg though, when they bump me up to 25mg next week, I should notice more of a difference if its the real thing and/or if it is going to work for me.

I don't know when the results will be out, I do know its just getting underway at some sites. Like where I am going, I am only the 4th participant - and they need 27.

I have to say everyone involved in the study has been WONDERFUL to me! :woohoo: (very refreshing change from a uro who basically told me to go home and hope it goes away!!)
Janice

[Babs RN]

Janice, that is so cool. It is also nice to hear first hand from someone involved in a study, thanks for sharing your experiences. It puts a human face on the study. I hope your pain continues to improve.

Hugs and thanks,
Barb :grouphug:

[sweet candy]

elmiron seems to be the only drug my doc. prescribes and oh yeah the catheter injection that works for about 2 wk s. do you think a uro dyn. test is worth doing on me? i am very tired of this whole process.

[JaniceB]

Barb, yes I'm very happy with things so far. Of course no one knows for sure if I am on the real thing, but I'm really starting to think maybe I am, because something is helping! I had severe pain for the past several weeks, yesterday, it was much better, today I have really had no pain at all.

In fact, today was the first day I was able to scoop up my 2 year old and play with him and hug him - all without pain. I havent been able to do that in weeks!! Quite an improvement just from Monday when I was lying on the bathroom floor crying from the pain! That alone, means so much to me.

I am hoping it continues to help and I hope my participation helps someone else in the future.

Janice

[Janie Miranda]

Janice,
Thank you so much for participating in the study! I'm also so happy to hear that you are feeling better. I hope you continue to get better and better.

[icsonja]

:woohoo: So happy for you, it is so inspiring to hear that your pain is so much better! See no study is worthless is it? Look at what this is doing so far for you . You just give that baby a big ol hug from me too!I missed giving mine alot of them due to pain so I understand how much joy it gives you to be able to do what many other women w/ o thinking about it.
It makes it all so much sweeter, when you have had to miss out on the hugs and now you get to hug and play and do mommy stuff. I am thrilled for you, nothing feels as good as your babies all wrapped up in your arms. Enjoy, you deserve it as do they.
Trials may seem trivial to some who want other, better treatments, but for this mama it wasn't an unimportant trial. She is hugging her baby. Great result in my opinion. :kissing: