# Anybody on the clinical trial for Talnetant(Glaxo)



## SpAsMaN*

I can't find any update on Talnetant.







It was promising...Anyone ever been on the clinical trial?


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## jjohnson

Spasman,I can't say I've heard any real update on this drug. However, GSK did just update its pipeline on its website in November (for the first time since December 2003) and talnetant is still there in phase II but now has an estimated filing date of 2007, which leads me to believe that the company is either seriously considering or has already taken steps to move this drug to phase III.


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## SpAsMaN*

2007 is way too long.Something will happen for me before.It break or it pass.BTW,i have been trown out of the Talnetant trialfew years ago.I wasn't feeling it anyway.But even the specialist seems to evoid or forgot about Talnetant now.







He claims that it may reduce the sensitivity and even cure IBS in few weeks.Testosterone would be stopped during the trial.


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## jjohnson

Spasman,I'm a little confused. Is this drug supposed to affect testosterone? Also, you mention that your specialist has heard very good things about this drug but is also forgetting about it. Please clarify.


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## SpAsMaN*

Quote:Also, you mention that your specialist has heard very good things about this drug but is also forgetting about it. Yes,that's it but i wait from him to call me back to clarify.His claims was 2 years ago.And yes Talnetant stop ALL testosterone when you take it.Quite scary but who cares in our situation.


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## SpAsMaN*

Testosterone come back normal after you stop it.Hopefully







Since my specialist has lost his memory,i wait for a surgeon specialize on IBS to call me.His Talnetant trial start in January.But i'm afraid that Talnetant didn't work since my doc forgot about it.


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## jjohnson

Thanks Spasman,I understand you now. I have to agree that the effect on testosterone is a little disturbing. Not sure I will be trying this one unless I find absolutely nothing else that works within the next 2-3 years.


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## jjohnson

Also, just wanted to mention that if this is a side-effect of the drug it will probably be possible to take testosterone replacement therapy to counteract it. I know taking additional medications to control the side-effects of a primary medication is common in the case of some disorders like schizophrenia and epilepsy.


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## jjohnson

Spasman,One more thing. You mentioned that you can't wait till 2007. I believe that talnetant is being studied for all subtypes of IBS. I am IBS-D. There is another drug for IBS-C that could be out in 2005 in the US (probably a little later in Canada.) It is called lubiprostone. It has finished clinical testing for chronic C and the company is preparing an NDA. It will be entering phase III trials for IBS-C soon. But if it is approved for chronic C, you could always get an off-label prescription for IBS-C (since it is basically chronic C plus pain.) Anyway, here is a press release from Sucampo, the company that intends to market the drug. http://www.medicalnewstoday.com/medicalnews.php?newsid=15731


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## SpAsMaN*

Good find Jhouston with lubiprostone!I have receive an e-mail from them and i'm confuse about the clinical trial here in Canada.When and where?


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## jjohnson

Spasman,I'm not sure about this. I would email the company again and/or post a question about this (or about clinical trial resources in Canada generally) on the main forum, since I don't think many people will see your question here.


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## william brown

I just received a call from Radiant Research to see if I was interested in another clinical trial-- last time was colansetron. New trial is for a company named TRINE for a test for ibs-d. Sone kind of "natural" drug found in south america, tentatively named crofelemer. I can't find anything on the web for this company, or thew drug, although it's supposed to be in pase III testing. Anyone ever heard of this company? Bill


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## jjohnson

Bill,I came across this drug I think on Centerwatch. The company appears to be some sort of small start-up with no marketed products. I wish them luck but I'm not about to get too excited about this one. Maybe I'm just a little cynical about anything labelled "natural" because of the endemic fraud in the herbal supplement industry.I also know that a company called Dynogen is studying two drugs for IBS, one for type D and one for type C.I don't think these companies have the resources to conduct trials as quickly and efficiently as the larger companies. And it's a little bit depressing that none of the big pharmaceutical companies (besides Glaxo) seem the slightest bit interested in IBS.Also, weren't you taking Lotronex? I hope you are still able to get it and doing well.


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## sok-in

With all the "clinical trial chat" on this thread (great info by everyone, ty!!) has anybody heard anything on renzipride lately, or even orbec?


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## jjohnson

Onnassis,Renzapride is due to start phase III trials for IBS-C and IBS-A in the first half of 2005 after positive results for phase IIb trials. http://www.hemscott.com/hstoday/focus_2004...E_2709_2004.htm I don't think I've ever even heard of orbec, but I'll try out a Google search on it.


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## SpAsMaN*

Renzapride Onnasis,not renzipride i think.I will look about Orbec.


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## jjohnson

It looks like the company that makes orbec will submit an NDA for the drug around April, but unfortunately not for an indication for IBS. The latest I could find on that was that the company was testing this drug in phase II, but that was sometime in 2003. This sort of thing has happened before. I remember a few years ago one company (maybe Pfizer or Lilly) was studying a drug for IBS that was eventually approved for, I think, overactive bladder. Well, you win some you lose some.


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## william brown

jjohnson-- you are right on RINE- but if this has already gotten to third level testing I think it may have some potential. I also agree that thse "natural" remedies are often susppect at best, but alot of people swear by ibsacol. Turns out TRINE is a privately owned company, and may have more $$ than anyone knows about. I may look into the trials in January. Bill


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## SpAsMaN*

I have an appointment with one of the best surgeon and IBS specialist in canada.January 3 2005.He also start a Talnetant trial in January 2005.Apparently,Talnetant may reduce the sensitivitypain of the bowel.I Still want more infos from the people on the clinicals trial.







It's a double blind research then no patient,no doctor knows who's takes Talnetant.


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## jjohnson

Bill,I agree there may be something to this drug if it is in phase III, unless it ends up becoming another naltrexone.Spasman,I haven't heard of anyone in a talnetant trial on this board. If you want to know about peoples' experiences with clinical trials generally, maybe you should post a question in the main forum. Even then, it seems like a long time since anyone here was in a trial. If you guys decide to go ahead with the trials, best of luck and please keep us updated on your progress.


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## cat crazy

SpasmanThe clinical trial study for Talnenant is in it's phase 111. I was contacted by the clinic in Thornhill area in Toronto. You have to go through a colonoscopy prior to the trail and also since the drug if successful will not be marketed until a couple of years I declined it. I have ibs d and in my previous trail with Lotronex which was taken off the market in Canada in 2000 and not available anymore here I am disheartened. But if you would like more info on the clinic and the study you can email me and I can forward you the tel#. Mostly the drug is for the pain and they said it smoothes out the peristaltic movements to normalize the digestive process.


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## SpAsMaN*

Hanna,if Talnetant dosen't appears on the market before 2007,wouldn't be a good idea to try it for 2005?I heard that the effects can last for years!Hopefully good effects...You got mail.Thanks


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## SpAsMaN*

I have news from the Talnetant trial.







I just talk to a nurse involved in 2 clinicals trials phase III on Talnetant.







SHe said:-The Testosterone IS NOT reduce while they were on it.-Reduction in sensitivity







-Help the motility







-It was a 4 week test,1800 IBSers-The symptoms will probably comes back but maybe with less severity-Side effect like head ache,nausea 2-3%-No one were cured but it reduce the symptoms


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## SpAsMaN*

Maybe if people still take it for many months they can improve even more.Who knows?Hopefully the nurse does not suffer from over-positivity.


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## SpAsMaN*

The problem IS that a colonoscopy in the last 2 years is obligatory to participate.


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## jjohnson

Spasman,Thanks for the info. It looks like Glaxo is really moving along with this drug. I'm glad to hear it doesn't affect testosterone after all.


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## SpAsMaN*

I'm registered locally for the Talnetant trial.I'm glad that i did a Barium enema recently because Glaxo ask for one and a short colonoscopy(2 feet).The trial will last 8 weeks and i think my testosterone will be recorded during the trial.I'm little bit worried because i think the drug cross the blood-brain barrier.


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## SpAsMaN*

Talnetant info trial in the whole America with phone numbers contact: http://www.controlled-trials.com/mrct/tria...1059/74807.html


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## Nath

Good Luck with the trial Spasman


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## jjohnson

Spasman,There seems to be a little bit of conflicting information on the exact status of this drug. According to the link you just posted, this drug is only in phase II, while you and Hanna have both heard that it is in phase III. This could make a huge difference in when the drug might be available, as well as whether the proof of principle has been established (in other words, does the drug actually work.) I don't think the website you posted was edited very carefully, since it refers to IBD as Irritable Bowel Disease, and one of the drugs not permitted, mertaxapione, doesn't exist (they may have meant mirtazapine), so I guess its possible that they might have marked it phase II when it is actually phase III. Your earlier post that mentioned that 1800 people were being recruited sounds like a phase III number to me, although I'm no expert. Anyway, since you're doing the study, I was wondering if you could try to clear this up. Any infor would be much appreciated. Best of luck with the study and keep us updated on how you're doing.


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## SpAsMaN*

JJ,i just e-mail them about the "phase II" thing and that the fact that the clinic are recruiting now...I think you saw IBD in the exclusion criteria,you have made a mistake on that one







.That means if you have one of these criteria,you can't take part in the study :Quote:Exclusion criteria:Self-assessment of no stool for 7 days during the two-week screening phase. Clinically significant abnormal laboratory tests. Current evidence or history of various conditions, comorbidities, or surgies such as Irritable Bowel Disease (IBD), gastrointestinal surgeries, and diverticulitis. Inability to use the touch-tone telephone system. Hypersensitivity to quinolone antibiotics or quinolone derivatives. Diagnosis of a psychiatric disorder within the past 2 years and not on a stable dose of medication for at least 6 months. Women who are pregnant, breast feeding, or planning to become pregnant during the study.


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## SpAsMaN*

I think Talnetant is a NK3 antagonist and who cross the blood-brain barrier. BTW,i think it target all forms of IBS.D-C-A.Correct me if i'm wrong.But it is confusing,them claims it REDUCE the motiliy in this web site:







http://www.emedmag.com/html/pre/gic/consults/061504.asp Quote:"Neurokinin (NK) antagonists are thought to reduce pain and motility. These include the NK3 antagonist talnetant, which is currently under investigation in the United States."


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## jjohnson

Spasman,Talnetant is an NK3 antagonist and I believe it is being studied for all subtypes. I would love to see the results of the phase II trials (maybe at DDW this year.) There is an opoid antagonist that does not cross the blood-brain barrier being studied by Merck called asimadoline. It had been so long since there was any new info about this drug that I thought they might have pulled the plug on it, but there is scheduled to be some discussiion of it at the IFFGD conference in April, so maybe they are still studying it. Also, I saw on another thread that your doctor isn't letting you do the talnetant trial anymore. Very sorry to hear it.


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## SpAsMaN*

HI JJ.I have edited my last post.My doctor didn't want to -refer- me but i'm still register to the trial which is at another center.I will find another doctor to refer me.


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## jjohnson

Glad to hear you're still in the trial.







I did look at that site you posted but I wouldn't worry about that too much. For one thing, trials for the drug Zamefinacin were discontinued by Pfizer I think around 1999, so the person who wrote the article might not have done their homework all that thoroughly. I think GSK probably has good reason to believe that talnetant will help IBS-C patients as well. Also, asimadoline still seems to be very much alive, according to an annual report issued last week, although its been stuck in phase II for years.


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## SpAsMaN*

So...anyone?I'm still confuse if it is phase 2 or 3.


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## jjohnson

Spasman,According to GSK's Q1/05 presentation, this drug is still just in phase II. Great.http://www.gsk.com/financial/presentations.htmAlso, are you still going to participate in the study?


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## SpAsMaN*

Maybe.First i need to suffer the shame of another colonoscopy and wake up the center here who does the trial.I wish it was phase III.


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## Guest

please help...i have been interested in the progress of talnetant for some time and have done as much research as the internet seems to allow...i look forward to experimenting with talnetant as soon as it is approved, althought it is currently only in phase II...i am excluded from becoming involved in any of the current trials, but am wondering...i have heard that similar drugs that cross the blood-brain barrier and are additionally used for mental disorders like schizophrenia as well as ibs can have harrowing side-effects. now while recent research shows a mild side effect profile that discludes weight gain or insomnia, i wondered if anyone had any additional insight about talnetant's side effects and what, along with testosterone reduction, we might expect to experience if trying talnetant. thank you for your help.jteverspennsylvania


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## jjohnson

jtevers,I'm not sure how much we'll be hearing about talnetant for the time being. GSK is an enormous company with dozens of compounds in phase II testing, so we'll probably have to wait until (if) some efficacy is seen with this agent before we hear more.This drug is also being studied for schizophrenia. I wouldn't let that bother you, though. I used to take Seroquel for anxiety and insomnia, and believe me, you get over the idea of taking an anti-psychotic pretty quickly. And most of those drugs are in fact very safe and well tolerated. Not sure if that has anything to with crossing the blood-brain barrier or not.


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## SpAsMaN*

Stupid nurse, she never call me back.







Now my local trial is over for now.


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## SpAsMaN*

Next hope?Users?


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## jjohnson

Spasman,Did you mean that the trial for this drug was cancelled in your area or do you mean that they just didn't allow you to participate?Also, Lubiprostone was submitted to the FDA in April but I haven't heard anything since. (I have to admit I haven't followed it that closely, though, as I have IBS-D.) As far as I know there were no safety problems with the drug, nor any reason to doubt the efficacy. But it seems the FDA is taking its sweet time with NDAs since the Vioxx scandal. It could still come out in 2005 (or maybe the first half of 2006), though, in the US at least. Hopefully Canada won't be too far behind.


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## SpAsMaN*

Yeah she didn't call me back for the trial.







I don't know anything about it here.JJ,that's interesting about Lubiprostone.Is it a drug in the family of NSaids?


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## jjohnson

Spasman,From what I understand, Lubiprostone is a calcium-channel opener and should help C. As far as I know, it has no relation whatsoever with NSAIDS.


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## Guest

To one to all:I have just determined that one more promising drug, talnetant in development from GSK, has been DROPPED before reaching phase III and can be verified by their most recent product pipeline pages for November, 2005 made available at gsk.com.This is disturbing although it remains in phase II of development for schizophrenia and may in the future be possibly prescribed off-label if it becomes a popular solution.Any insight?JohnPennsylvania


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## 16082

This is a dangerous drug. It caused me to go unconscious. I fell down and have permanent injuries. Glaxo Smith Kline's Attorney's, for the clinical trial I was on, are stonewalling me. Has anyone out there sued them for this awful drug or dealt with Glaxo Smith Kline before? Please contact me at dlight69###hotmail.com


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## SpAsMaN*

wow,i have heard weird stories for this non-approoved drug.I'm sorry.


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