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Discussion Starter · #1 ·
Hi all- There are so few posts in this area of the Bulletin Board that I'm guessing not a lot of people are getting Lotronex these days.Has anyone been through a Lotronex study? And if so, how did it go and what were some of your experiences with it?Even though I was on Lotronex successfully in 2000 when it was out, I've been trying all summer to find a doc here who will prescribe it and the closest I've come is one who's doing a study at the U. of Rochester. I asked twice if they could possibly just give me the prescription without going through the study (and the 1 in 3 chance of getting a placebo) but he said no. So what could I do but volunteer for the study?I would like to feel more charitable about it, and think of all the people I might be helping by hopefully adding some positives to the Lotronex battle for acceptance, but pain, cramping and missing work make me more selfish than I'd like to be. I was hoping for the quick fix, and I'm envious of all of you who've been able to get prescriptions for the miracle(to me)drug!Anyhow, it's good to be able to talk about it..thanks for listening.
 

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susango,I am sorry to hear about your problems getting Lotronex and I fully understand and sympathize with your reservations about taking part in a clinical trial. Still, I am intrigued by this study. Since the efficacy of this drug has been established and only the safety is in doubt, why would the study be placebo-controlled? There seems to be a good deal of reasonable doubt about whether Lotronex is actually responsible for ischemic colitis, and I have heard of plans to investigate this, and a placebo-controlled study would seem to me as a layperson to be the best way of doing this. Makes you wonder. At any rate, such doubts have been taken seriously by such eminent researchers as Dr. Michael Gershon, and I don't think GSK would undertake such expensive studies unless they had some reasonable basis for questioning the causal relationship between Lotronex and ischemic colitis (if indeed that is what this study is about). There are numerous studies listed on the Centerwatch website for trials on a drug for women with severe IBS-D who have failed conventional therapy, which sounds to me a lot like Lotronex, though it is not mentioned by name. Anyhow, sorry for being so long winded. But if you decide to participate in the study, susan, please do try and find out what the purpose of the study is, if they are willing to reveal it. I'm sure a lot of people here would be interested to know. If not, believe me I understand completely. Best of luck. Any thoughts on this, anyone?
 

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GSK committed to a number of studies as part of the agreement to bring Lotronex back, but none of them required placebo control (they were about dosages, intermittent use and things like that), so I have to think you are correct, jjohnson. In further support of your theory, my GI told me that during the last Digestive Disease Week conference (I think it was in April), there was a lot of talk among the docs about maybe ischemic colitis is more prevalent in people with severe IBS and has nothing to do with what drug people are taking. Studying something like that would require a placebo control. Susan, you will probably have a good idea of what they are studying after you read the informed consent, which is usually pretty comprehensive, and you have had a discussion with the research coordinator. Like jj, I am intrigued by what this study might be about. If you get any information, please let us know. And, good luck with the study. I hope it's the kind where after the 12 weeks are over, you'll be able to get Lotronex with no more problems for the foreseeable future.
 

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Discussion Starter · #4 ·
Although I don't remember an exact reason given, the research coordinator did tell me that they are testing different types of dosing. I believe I'll either be given the medicine(or placeb) once a day, twice a day, or as needed. Something like that. Ischemic colitis was mentioned, but I'm not sure that's the purpose of the study.As prep, and to qualify, I had to have a colonoscopy 2 weeks ago(ugh), then wait a week, then start a phone diary for 11 days for them to have a "baseline", and then next Monday I will meet with the research guy again and he will tell me what the protocol will be for me.I did sign a lot of forms, and I know I should have made sure I got copies of them, but I forgot and I think he did too. When I go in Monday I'll have to remember to get them..Anyhow. I will let you know what I find out..
 

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I participated in a study by GSK that started last August(2003). I also had to have a colonoscopey, bloodwork, etc. before I started. I was told there would be a 50/50 chance I would be taking a placebo. I did all the daily phone calls to GSK, etc. I had to have bloodwork every few weeks. I knew within days I did not have the placebo. In retrospect, not sure exactly what they were looking for as they started me on 2mg/day (1am and 1pm). Anyway, I am still on lotronex and it has certainly helped my situation... Possibly the studies now are looking closer at IC. It would probably be marketed more widely if they can prove it does not cause IC. I think too many doctors prescribed it for people with complaints of episodes of diarrhea, not IBS. I'm sure this could have caused some problems. Educating the physicians is not an easy task.... Good luck with the study!
 

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Discussion Starter · #6 ·
Thanks, lionala- I hope to have the same luck! Speaking of luck, this week as I do the daily phone calls before I get the stuff, I've actually been better than I had been in weeks.. no complaints here, though!
 
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