# Arverapamil (ARDIS-1) Trial STILL RECRUITING (anyone participating?)



## Ravenous (Oct 25, 2007)

The phase II patient trial for Arverapamil was very promising for IBS-D sufferers and they are still recruiting for the Phase III (1200 patient) trial: http://www.seroba.ie/seroba/Main/PressReleases-April07.htmI found a clinic in my area at this website http://clinicaltrials.gov/ct2/results?term=ibs&recr=OpenAlthough I can no longer find it listed there (try looking for AGI-003 as it was called before Averapamil) or check your yellow pages/google for a clinical trial clinic in your area and check their website to see if they participate.Anyone else like me currently in this study to compare notes and such? I get the drug or placebo on Monday (75% chance I get some sort of dosage of the drug). Phase III trials are usually dosage studies to determine the correct dosage and they have already been tested on humans successfully so are usually safer.They do permit a 'rescue' drug such as Immodium (loperamide) in the event you do not get the drug and want to continue the study. Although I'm doing this in the event (not for the money) I build up a tolerance to Loperamide and need to know about something else that works, the $40 check each visit is nice to receive for my time and travel expenses. I just hope that if it works I get picked for the year long study afterwards.Hope to hear from someone else in the trial. Let me know if you wish me to update this as it goes or upon its conclusion.Peace


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## Ravenous (Oct 25, 2007)

I've just been told I'm selected for the study. I'm getting the Averapamil drug/placebo today. Let's just hope I get the drug because the past few two going off Immodium Lopermide have been horrible.I hope this drug will work in the event I build up a tolerance to Loperamide. I also hope that if I need the "rescue drug" Loperamide that the two won't be too much and cause things to go the other way. Hoping...


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## Ravenous (Oct 25, 2007)

I GOT THE DRUG!!! How can I tell when it is a double blind study with placebos? Because only one of the three pills I take is bitter and the other two are cornstarch or something tasteless. And also because I feel GREAT!!! This stuff is way better than Immodium Loperamide. Even with Loperamide I still felt some minor bloating kinda like being aware of your stomach when your not aware of your heart and lungs unless there was a problem. Anyhow that awareness is totally gone. I feel like I can even start doing situps again. For all those with tolerance to Loperamide this stuff might just be the answer to our prayers. I'll keep you posted....


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## Ravenous (Oct 25, 2007)

Not sure why none of you here seem at all interested in this new drug since this drug is going to provide long term relief for so many of us with few side effects. Anyhow, here is an update.After 4 weeks of being on Averapamil I feel great and have been symptom free with no bad drug side effects. This may not be a cure but I've got my life back and there seems to be no tolerance effect like there is with Loperamide. I can eat what I want now. The only drawback is having to take it 3 times a day but since this trial is to determine the proper dosage I know that it probabaly won't be 3/day when released to the public. I have told them that when I miss one pill the symptoms return (although much milder) so I feel that the dosage I'm gettting is probably the bare minimum it should be.Assuming it passes the current clinical trial I'm in and the long term study for next year Averapamil should hit the market around 2010. So I don't need to worry about building up a lifetime tolerance with Loperamide because this new drug will not have that effect. From what I hear they are still recruiting people for this clinical trial. Even though I'll need to go off the drug (unless I am one of the few chosen for the year long study) at least I got a few months of relief and some hope that something is coming along to help me.This drug company is going to be developing drugs solely for the IBS market which they feel has been overlooked by other drug companies. All of the drugs they are developing will be for intestinal/digestive problems.RegardsRavenous


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## tupperwarepatty (Jan 3, 2008)

wow that is great!! i just logged onto this site today and ahve been reading some of the posts. i just scanned the clinical trials \and none of them are near me. do they ever accept you for a clinical trial and then get the medicine from a local doctor? my brother was in a clinical trial and he took the meds home and then went back to be monitored. I agree that we have been ignored by the drug companies. I have been on bentyl for over 20 years....


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## John1988 (Jan 2, 2008)

Is this a United States study or can United Kingdom people take part ?


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## Ravenous (Oct 25, 2007)

Hello PattyI found the link to the study on the clinicaltrials.gov website. For some reason I couldn't find the specific study when I posted this thread so here it is: http://clinicaltrials.gov/ct2/show/NCT0055...Open&rank=5Click on the Contact/Locations Tab on that webpage to find participating clinics/physicians near you or contact Susan Cooper (910)558-7044. I think you would need to go to a clinic because there is a lot of testing involved and I'm not sure a general physician would want to be bothered. However, you will only need to go to the clinic once every 2 weeks to get the medication to take home. I go to a clinical research clinic for lab tests and to get the medication. I've been very pleased with the relief I've received from this medication and have hope that I will be able to live a fulfilling life. Although there may be no cure for IBS-D this seems to be the closest drug to a cure. I've had no side effects and am mostly symptom free as long as I remember to take it. We have been ignored by drug companies until now. Regards


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## Ravenous (Oct 25, 2007)

Hello JohnI found a website which is a portal to finding clinical trials worldwide: http://www.controlled-trials.com/For the UK the website is: http://www.controlled-trials.com/mrct/search/21/10/1/asc/Since the drug was developed in Ireland those in the UK probably will be participating.


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## Ravenous (Oct 25, 2007)

Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) Link to the ClinicalTrials.gov record Information obtained from ClinicalTrials.gov on December 31, 2007 Title of trial/grant title Efficacy Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) Current status of trial: Recruiting Sponsors and collaborators: AGI Therapeutics, Inc. Information provided by: AGI Therapeutics, Inc. ClinicalTrials.gov identifier: NCT00552565 Purpose: The purpose of the study is to determine the efficacy and safety of Rezular (arverapamil) inthe treatment of IBS-D. Condition(s): Irritable Bowel Syndrome With Diarrhea Intervention(s) Drug: Rezular Phase: Phase III Study type and design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Rezular (Arverapamil) in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) Further study details: This study has been designed as a multi-center, randomized, double-blind, placebo controlledparellel dose group trial. The study will be open to both women and men. At screening thepatient will be assessed to see if they meet the Rome III criteria for IBS-D. Afterscreening, patients will undergo a 14-day run-in period evaluation, during which eligibilityto be randomized to drug or placebo will be determined. Patients will complete dailytelephone diaries during the run-in and double-blind phases of the study. Patients will beevlauated at regularly scheduled clinic visits during double-blind phase of the study. Study start: September 2007 Expected completion: July 2008 Minimum age: 18 Years Maximum age: 70 Years Gender: Both Eligibility criteria: Inclusion Criteria: fulfilling Rome III criteria for IBS-DExclusion Criteria:major cardiovascular diseasepsychiatric illness except mild or moderate depressionpregnancypresence of other GI disease that could explain IBS-like symptomshistory of major gastric, hepatic, pancreatic or intestinal surgery or perforation Overall contact: Susan Coopertel: 9105587044 Locations North Carolina, United StatesPPDWilmingtonNorth Carolina28401Status: Recruiting Study ID numbers ARDIS-1 Last updated October 31, 2007 Record first received October 31, 2007 ClinicalTrials.gov identifier NCT00552565 Download date Information obtained from ClinicalTrials.gov on December 31, 2007


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## degrassi (Jun 10, 2003)

I wish I could find a trial like this in canada.


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## Ravenous (Oct 25, 2007)

UPDATE:After being selected for the 1 year Phase III Long Term Dosage Study (after completing the initial 6 month study) I can report that I have been IBS-D symptom free for 6 months now with NO SIDE EFFECTS or tolerance build-up. They are trying to work out the proper dosage with these studies and it seems this drug Averapamil will be approved by FDA and marketed around 2010.THERE IS HOPE. I GOT MY LIFE BACK!


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## Lillett (Jun 4, 2006)

That's wonderful. Hopefully it will become available to others.


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## jason haberland (Jun 28, 2004)

Ravenous, that is great news! I believe I have built up a tolerance to immodium and now have to take 6 a day when 2 years ago I took 4 a day! Do you have any information that the FDA would approve this drug/when it would come out and any other info about what it's like to take this drug? I still get alot of bloating with immodium after I eat lunch and feel crampy the rest of the day, does this drug stop that also besides D?


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## Ravenous (Oct 25, 2007)

Hello SageUnfortunately, all the information I have is already here above in this post. Since I am one of the first in the US to enter the final phase (1 yr long term dosage study), we might see this on the market around 2010 if approved by the FDA. I expect it will be approved because I'm told the majority have had no adverse reactions and complete alleviation of symptoms including bloating. Since I was one of the first to start the final phase 3 dosage study they have been monitoring me closely to determine the proper dosage.Honestly, I'm quite surprised at the lack of interest in my post and in others wanting to participate in the study when this drug seems to have few if any side effects and has no tolerance factor. I've even been accused here of working for the drug company but perhaps it's just my enthusiasm about having my life back that makes some wonder which side I'm on.I'm not sure how much more I'm allowed to say about it due to confidentiality concerns and competition. However, I can tell you that I've been symptom free for over 4 months now including alleviation of bloating/cramping/abdominal pain and anything else. It is a drug that will need to be taken daily because my symptoms do return if I forget to take the full amount perscribed. It is NOT a cure but it also does not have the tolerance effect that some experience after years of using Loperamide. As far as I know the trial is still accepting patients. The link is above where you can find a local clinic in your area to begin the dosage study. Phase 3 studies are usually safer because they are primarily concerned with dosage and many others have already taken the drug in the Phase 2 so you aren't in as much risk as might have been with an untested medication. Oh and just to be clear since I may not have mentioned this much in past posts: this drug will only be for those with IBS-D not for IBS-C. Since IBS-C seems much more treatable with fiber etc. I'm so glad that they are coming out with someing for those of us with IBS-D.Regards


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## Ravenous (Oct 25, 2007)

here is the link to all IBS clinical trials:http://clinicaltrials.gov/ct2/results?term=ibs&recr=Openhere is the current link to the specific study which changes as newer ones are addedhttp://clinicaltrials.gov/ct2/show/NCT0055...Open&rank=7


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## jason haberland (Jun 28, 2004)

Ravenous,I really appreciate your long response! This gives me great hope because I'm worried that if I'm taking 6 immodium a day now and still in pain, what will it be like for me in 2 years? This drug sounds like a ray of hope for me and other sufferers who have bad D!! I am going to follow this closely and look for it in my area, I live in Boston, MA!I have definately developed a tolerance to immodium and I try to take Lomotil about 3 times a week so this drug would give me something else to take besides Immodium! Please keep me posted on this drug and keep posting on this site so that we know what the company is going to do next in the PHASE 3 studies!Thanks again Ravenous!


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## John1988 (Jan 2, 2008)

Thanks ravenous, There is hope for all of us Unfortunately there are no trials in the UK, Even though the drug is produced in Ireland !!


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## Ravenous (Oct 25, 2007)

Hi SageWhy not enroll now in the study instead of waiting until 2010+ for relief? They even pay you to do it. I'm sure there are clinics in your area that can enroll you. Check out those links and you can find one in your area. If selected for the study you could take the drug for about 1.5 yrs which is seems better than suffering until the drug is marketed. I'm so glad I took that step and am no longer suffering and have my life back.


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## tbd (Feb 19, 2008)

I would have loved to sign up for the trial but I am in the NYC area and it looks like it's in North Carolina. Please keep posting any updated info as it does sound interesting.


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## Ravenous (Oct 25, 2007)

I'm not sure how to make this any more clear: This study is NATIONWIDE. The drug is only made in North Carolina. Due to FDA regs it cannot be made in another country for a Phase III test study. I'm not sure what happened to the website that was so easy to use before. It used to have an interactive map and I clicked on my state and found the clinic in my area simple as that. Now there is no map to find your clinic once you find the study. Susan Cooper 910-558-7044 is someone you can contact to find a clinic in your US area.


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## jason haberland (Jun 28, 2004)

Ravenous,I'm glad your doing well with this medication! From being involved with the studies, have you been given any information that the FDA is going to approve this drug and when? This could be a great breakthrough that I would have to look forward to !


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## John1988 (Jan 2, 2008)

I want this drug realy bad


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## petekurtz (Jan 2, 2008)

I don't know what arverapamil is compared to verapamil. I posted a blog some months ago about my wonderful, and I mean complete cure, experience on verapamil. I am glad you are in a study about this drug. Hang in there. 60 years of pain, discomfort and torture are gone. I can eat anything although I watch my diet, but now I can freely eat all sorts of ruffage, whole grains and mexican beans. And I eat all these things because verapimil(and I am on the smallest dosage of 180mgs daily) is somewhat constipating. But I go everyday with ease and since September of '07,except for a 1 day virus, no loose stools. Even that one day, and only fellow IBIS sufferers know what a stomach flu can mean, it went by fast and easy. Let me know how you [email protected]


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## John W (Feb 9, 2008)

Ravenous,Have you tried Zofran or Lotronex before? If so, how would you say Arverapamil compares to them?


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## h8ibs (Oct 24, 2004)

Petekurtz, check out this link, it might answer your question on verapamil vs. arverapamil:http://www.drugdevelopment-technology.com/projects/rezular/


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## sunspot19 (Aug 31, 2007)

Pete:Can you let us know where you blog is? I looked but could not find it...!Thanks.


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## petekurtz (Jan 2, 2008)

Sunspot19-I am lousy at finding things even when I've written them. I will summarize. I am 63, my memory of painful spasms in my gut goes back to age 3. Suffice it to say, I have had horrible ibis experiences all my life. At times I wanted to do myself in. Although, in the last 10 years, I have had my gut under better control, ibis is always there, lurking. I have hypertension. I have terrific ibis type reactions to beta blockers and heart reactions to calcium channel blockers. In September of '07, my well known hypertenison specialist asked me to try verapimil, an old calcium channel blocker that works differently from others. The initial dose(180mgs) and the higher dose(240mg) did nothing for my blood pressure. But I could not help notice that my ibis was gone. It has remained gone 6 months later(I am taking the smaller dose just for my ibis). When I say gone, it is gone. The drug is readily available now. The one they are testing apparently discounts the blood pressure effect of the drug(although it does not work for me anyway). So have your doctor prescribe the small dose and see what happens!. I also start my morning with stonyfield yogurt, but I did that before verapimil and it was only partially helpful. If the drug works, start on the ruffage. And good luck!


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## petekurtz (Jan 2, 2008)

h8ibs-Thanks. That was very helpful. The verapimil I am taking does not effect my blood pressure at all, so a new version discounting the blood pressure effects will not affect me down the line. Right now, the old verapimil has cured my ibis and I plan to take it for life. Thanks again and good luck!


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## John1988 (Jan 2, 2008)

Petekurtz.. I'm going to my doctors next week to ask for that drug ! Thankyou very much. Fingers crossed


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## sunspot19 (Aug 31, 2007)

PeterkurtzDid you have mainly IBS-C or -D? Just curious since you referred to spasms but I wasn't clear whether your problem was constipation or diarrhea.Thanks!


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## John1988 (Jan 2, 2008)

I think that we have scared ravenous off I was hoping for more updates,


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## jason haberland (Jun 28, 2004)

What do you guys mean about scaring Ravenous off, I thought this was a promising new drug for IBS-D?


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## John1988 (Jan 2, 2008)

sage1979 said:


> What do you guys mean about scaring Ravenous off, I thought this was a promising new drug for IBS-D?


Sorry Sage, What I mean't was, Ravenous was trying to help people in the USA to get this life changing drug, and only a select few people registered interest in it..I can't get the drug because there is no testing in the UK , and will be going to the doctors this week to try and get the drug which pete was given for his heart condition,I was looking forward to more updates from Ravenous to find out what dosage he was recieving, but he appears to have lost faith in the forum users.


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## Yowie (Jan 4, 2008)

Wow, sounds encouraging.. hopefully there'll be a trial in Australia.


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