[Lisa K]

Hi Everyone... IBS2- Tom, Bill Brown, Big jon, Annette and all,Thanks to all who responded to my post under "Cilansetron's the real deal" thread (Tom's)On March 26, I was approved and given my first "test drug" - its been 5 days at max dose of 3 pills a day, and I can not tell the difference?!!

If I sound hysterical in my preface, I am. I need some help from those who are in the study, esp those who have successfully passed the "3 month trial" and are on the REAL drug. I am on the one-year double blind phase lll study, and not knowing if Im on a placebo or not is rendering me to sheer insanity and pessimism. Like some/many of you, I was on lotronex which undoubtedly was heaven-sent, tho it didnt cure my severity, it reduced the horrendous lower intestinal spasms & diarrhea to a "livable" extentwhile my upper GI symptoms remained gruesome, at least 50% of my GI disorder was partially "controlled". Sorry to go on, but its been a harrowing 2 yrs since Lotro's first debut, and life has never been viewed the same again. Please answer some questions:1) How long (many days, weeks) did it take for you to FEEL improvement with your IBS?2) How severe is your IBS? (mine is severe, I have delayed gastric emptying-upper GI and lower-GI Irritable bowel with severe cramps w/o diarrhea)3) How much time would you allow to safely deduce that you have been given the

placebo?4) By any chance, were any of you taking your last dose of lotronex right before you started cilansetron test drug?William- Bill- Brown, I am very sorry that you experienced adverse epidermic reactions to the real cilansetron. This April 23rd, all prayers sent, Lotronex HAS to come back. I hope everyone will feel much better soon. Im in great anticipation of the FDA GI meeting, and dragging my sorry-ibs-self to this meeting- something POSITIVE has to give, it just takes so much TIME, for us who are suffering every day. Take Care Everyone. and please write!Thank you very much

nervous wreck, Lisa K

 

[jlechien]

Lisa K,As I indicated in a previous post, I have been on the 'open label' phase of the Cilansetron trial for over 4 weeks. I'll try to answer some of your questions for your benefit and for anyone else curious about the effectiveness of the medication.(1) The first 30 days of the double-blind study brought no relief so I concluded that I was on the placebo. Within 3 days of the open label I was aware of changes.(2) I have to say that my overall symptoms are mild compared to what others have shared on this board. I have had problems for about 12 years - mainly frequent 'D' and tremendous urgency that i cannot control, especially after dinner. That has added to my anxiety and reluctance to be very far from a restroom. Traveling in a car (unless I am driving) or using public transportation heightens the anxiety.(3) I am positive that after the 3rd day of the open label phase I had the 'real' medication. In the study here, the first phase was double-blind 50/50. After that for 1 year, it's definitely the real medication. (4) I never took Lotronex so I have no basis for comparison. From what others have said (IBS-2 and Bill Brown) Cilansetron is not as effective as Lotronex. I understand that the first Cilansetron trial was three 16mg pills a day. The trial I participated in was three 2mg pills a day. I think it should be stronger.Just as an additional comment (sorry this is such a long post) my side effects with Cilansetron have been occasional upset stomach and nausea as well as increased gas, but I am willing to put up with the minor discomfort for the relief I am getting. I honestly feel like an increased dosage would be more helpful but I want to follow the rules until it receives approval. I can say, without a doubt, that it works perfectly for me - no D in over 4 weeks. No urgency, no anxiety, no panic over 'where's the bathroom'). I hope this wordy reply offers some help. As I have said before, I feel very fortunate to have less severe symptoms than many others on this forum. I pray that others will find relief!Bigjon kc

 

[Lisa K]

Thank you so much Bigjon in the Midwest

for the long helpful post. This will help others as well. Admittedly I have been hysterical/anxious over the wonderment of placebo?

Thus, Your answers helped very much. Especially in reference to the different dosages in previous phases/trials. I didnt even consider how the 2mg 3x a day would be ineffectual for my severe ibs case. I am very happy to hear that you are on the REAL drug AND that it helps you tremendously, and so quickly too! within 3 days, Im impressed. When I was first on Lotronex, I was so nervous-anticipatory of feeling better, I think it took roughly 2 weeks for the serotonin modulator to really work- and it did. However, I did suffer upper GI side effects with lotronex- some of which youve mentioned while on cilansetron- which is another interesting coorelation btwn these types of drugs. Youve mentioned that Bill & Tom, on the first trial, were on 16mg? Now we're talking. Solvay reduced the dosaging for later phases, to prevent possible ischemic colitis and or side effects? Curious to know for myself if I upped my dosage would I feel better? 3x a day is effective for "milder" cases. Mine is rather complicated. I have severe pain/spasms, Lotronex was "magical" in its temporary 'curative' powers, The Diarrhea/urgency was a partial component of my ibs, the other half was the incredible pain (usually preceding "D" or loose bowels). Today Im feeling a bit more optimistic, Thanks to some homework and your informational post. Im going to give it another week. It seems that it is helping a little comparative to lotronex. I have this strong impetus to UP the dose myself but of course I cant, since we have to adhere to the study rules. Besides its not worth being dropped from the study while this is the only "study" medication around.

Thank you again. I hope others too will (continue) to post their results or findings. I'll be sure to let everyone know how this Cilansetron phase goes as well. Take Care Everyone. Lisa K

 

[Maria Z]

Lisa,It may not be working for you because you may have the placebo. So even if you could "up" the dose you are on now, it wouldn't help you any better. What I've been interpretting from your messages is that you think you have the real drug and that the dosage you are on is just not working for you. So consider the fact that you probably have the placebo.I am assuming, of course, that you are still in the trials phase?Maria

 

[Lisa K]

Hi Maria,I "Think" I have the real drug, possibly its not enough for me, since I required one to two lotronex tablets. I need the REAL drug

Double Blind studies are somewhat heartbreaking. At least TELL me after a short duration, what it is, in case one is too emotionally crippled to figure it out symptomatically. While I have considered the placebo probability, I need to "experiment" - only then will I satisfy my own ibs curosity, I just dont want to blow my own chances. Geeez I cant be the only one torn apart with neuroses under double blind studies? I was normal once

Kidding aside, yes I am in the phase 3 Double blind study - where no one but Solvay knows who is getting the real drug. See you soon Maria in DC, I would really like to meet you. April 23rd is a very rare and exceptional day for us all. Take Care.Lisa K

 

[Maria Z]

Lisa,Look at it this way, you should be hoping that it is the placebo that you received, since it's not working for you. I would be more disappointed to find out that I had the real thing and it did not work for me. When does the study end? Just think though, from what I've been hearing, that after the study you guys get the real drug if you want it. I believe that's what I've heard. So, good luck. I hope for your sake and for ours too that you got the placebo and not the real drug.Maria

 

[Lisa K]

Hi MariaI am pretty downcast right now.Somehow I dont see the optimism in hoping I have the placebo when Im suffering severely.Its beginning of Day 9, and no news to rave aboutThis study lasts for 13 months, its the final phase, which is still randomized and double blinded! I was not even aware of the phase 2 trials for 18 weeks, that is more reasonable than putting some poor soul on a fake pill for all of 13 months. Today Im feeling like Ive been faked. Even tho I understood the stakes going in, I was praying for the real thing or a pill that worked just like lotronex, but eithercase, it is not working for me. Ive decided the only way to exact placebo theory is by going cold turkey, if I feel even worse than now (or the same), then my scathing curiosity has been met

Thanks for replying and listening to my concerns.Take CareLisa K

 

[william brown]

Lisa-- sorry you are having continued problems. i got through the first phase with cilansetron, but only with gritted teeth, and not much food. The problem is that IF I had the real thing, the dosage was too low to make any difference. When I ]got the real thing after the double blind study stopped then the skin problems started. A dermatilogist said it could be the pill. Now have been on vacation in Florida 2 weeks, and went back to zofran. Thge skin pproblems are gone. When I get back to columbus, I'll try the pill again, eliminate zofran, and see if the skin problems return. Even when on the real thing, it didn't stop the D., so maybe a greater dosage is needed. Will talk with the MD about it. I will be in Bethesda for the meeting, so maybe we can talk about ciolansetron as well as lotronex, but we still need to concentrate on lotronex. good luck-- Bill

 

[Lisa K]

Hi Bill

]Welcome back from vacation. Thanks for replying. Ive been fervently tracking cilansetron study folks down, and I am grateful for anyone who replied. Its interesting, about the possible epidermic flareup in connection to cilansetron. Im sorry you were placebo'd the first time around, and regret that you are facing uncertainty with the last round. I feel as if we are in the same boat... that is, I either had the real ineffective drug or the sugary one. Youve mentioned that you were on the real deal for 9 days before you quit due to skin problems? I didnt take my cilansetron today. Today is Day 11, the first 9-10 days, really was uneventful. Others have recommended Zofran, so what do I have to lose? I cant handle any more disappointing trials. Good Luck to us both, to all, and Will talk to you in Maryland

I called GSK today, wrote Janet at the FDA and am currently composing my Tom Perez testimonial, fearing writer's constipation tho

Stupid pun, but God I have to laugh amidst all this. Compare more notes then friends.take care to all.Lisa KPS ONE IMPORTANT NOTE RE: CILAN STUDYmy study coordinator at the Doc's office, emphasized that she was "told" by Solvay, that previous studies at the 16mg dosage was not any more effective than the 2mg dosage?!

Im not so sure about that, it doesnt make any biochemical or logical sense. But then how would I know if I have only the placebo to fluctuate the dosages with???

 

[doctorsommers]

I haven't heard that the 16mg dose wasn't more effective, but that happens in a lot of drug studies. Sometimes the dosages that are useful aren't at nearly the same potency that they are originally recommended. I mean, they have to essentially guess (educated guess, of course) at what doses to try.For example, when birth control pills first came out, they were at very high doses - high estrogen. This put women at risk for blood clots (albeit small), but eventually figured out that MOST women could get relief from menstrual symptoms and have effective contraception at much lower doses. I doubt they'd lower the dose if they didn't find the 16mg dose effective. I imagine it worked fine, and they are either seeing if the lower dose works, or just going for approval of the lower dose out of concerns of side effects

 

[JuliaNYC]

According to the information Donna posted, in the early studies the same response rate (62%) was found for those taking 16 mg and those taking 1 mg. It doesn't make much logical sense to me, but if those were indeed the findings, that's what Solvay is going to report to the FDA. What's more surprising is that the response rate was greater at the 1 mg dose than at the 8 mg dose. I think it may show that there is no "one size fits all" dosage of Cilansetron, which is what we've all been saying about Lotronex all along.

 

[jlechien]

JuliaNYC,I am interested in your comments about 2mg versus 16mg dosages in the Cilansetron trials. My study literature indicated that the initial 16mg trials were halted because of 'possible' ischemic colitis developing in one subject. Solvay entered a second trial reducing the dosage to 2mg to reduce the incidence of constipation. Not to argue, just to pass on what I know. I am in the 6th week of the 'open label' phase and genuinely believe that Cilansetron works like a miracle for me, but my symptoms are not as severe as others. I think a stronger dosage may work better for major sufferers. I guess that just reinforces the contention that there is not a 'one size fits all. Just wanted to add my $.02.~Bigjon kc

 

[Lisa K]

Thanks for all commentaries.Bigjon - Good to see you posting your success. I havent taken any Cilan pills since day 11. Had to stop for a few to re-assess the situation. Thanks for providing us with Solvay's findings. I was skeptical with the "no difference" study results during phase 2. In my phase 3 study consent form/literature, it does not mention any previous dosaging. Donna's article (Solvay's news release?) cited that difference. doctorsommers, I appreciated your opinion, & personally I agree with that "common/factual sense" Julia - are you on Zofran??Lisa K

 

[Lisa K]

Hi Folks Just an Update for those who might be interested: Ive resumed Cilansetron, and have concluded that I do not have the placebo, however, the current dosage of 2mg 3x a day is not effective enough for me, Ive moderated the timing of dosaging etc... and noticed some difference. Still anything to help ibs is better than nothing. It took me a few weeks to reach this determination. Cilansetron if marketed at 2mg is probably too mild for severe ibs sufferers like myself. Despite that, it is better than imodium AD, levsin or any other antispasmodic on the market. I hope the final dosaging can be adjusted per individual severity. Thanks to all who helped answer some of my queries, I honestly appreciated every bit of resourceful information you provided.Continued good luck to all and Lotronex IS going to come back after the 23rd - Thats the 2002 new year's resolution!

Take CareLisa K