Research Study Beginning for Anal Fissures

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Research Study Beginning for Anal Fissures

Postby happyass » 19 Oct 2007, 13:32

Severe Pain during your Bowel Movements?
Doctors would like to talk with you about medical research studying an investigational ointment to see if it helps relieve the pain associated with anal fissures, a medical condition that causes severe pain, bleeding and itching around the anus.
Local doctors are now looking for adults who are experiencing symptoms associated with an anal fissure, to participate in a medical research study evaluating the safety and effectiveness of an investigational ointment to see if it helps relieve pain.
To be eligible for this study you must:
1. be between 18 and 75 years of age.
2. Have an anal fissure for at least six weeks prior to the study.
Symptoms may include:
-severe pain during and after a bowel movement
-bleeding around the anus following a bowel movement
-itching around the anus
Qualified participants will receive study-related medical evaluations and the investigational ointment at no cost. Reimbursement for time and travel will also be provided.
To learn more about this study, please contact Chevy Chase Clinical Research at 301-652-5520.
This is an anal pain trail.
****
For those of you not in the DC/MD/VA area, give them a call anyway to see if they know of any recruiting trials in your area. It is worth a shot! They may even bring you here to DC/MD/VA. Who knows??!!!
Good luck.
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Re: Research Study Beginning for Anal Fissures

Postby Guest » 19 Oct 2007, 15:19

Buttgirl-I wonder if this is that cream you were telling me about a few weeks ago?
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Re: Research Study Beginning for Anal Fissures

Postby Deleted User 5 » 19 Oct 2007, 15:36

I hope we all get to hear about the results soon! It will probably take years....
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Re: Research Study Beginning for Anal Fissures

Postby Guest » 21 Oct 2007, 13:56

I think I looked into this if its the same study @ Clinical trials.com. The only drawback is that its a double blind trial and you may get the placebo.
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Re: Research Study Beginning for Anal Fissures

Postby happyass » 21 Oct 2007, 15:56

i think if it is a double blind trial perhaps if it is a short trial then everyone in the placebo group would be offered ultimately the trial ointment.
i didn't inquire whether it was a double blind or random blind or how many arms it had or what other procedures are built in place for those who may or may not be on placebo, but it is worth a shot looking into for anyone.
****
for whatever it is worth, you can always go to target and take the generic tinactin challenge and put some on your butt and see where that takes you over a couple or three days. i don't see how it would hurt if you haven't tried it! :-)
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Re: Research Study Beginning for Anal Fissures

Postby Guest » 21 Oct 2007, 19:04

Dont get me wrong i think this is great info, and I'm really glad the drug companies are paying attention to us fissure sufferers, But I just could chance getting the placebo. So far, the Nitro I'm using at 0.2% is saving my life, i couldnt stop and go back to severe pain again. here is the info on the study:
What treatment will I receive during the APT study?
Study participants will be randomly assigned (like the flip of a coin) to one of two treatment groups:o Group 1 will receive Cellegesic Nitro-glycerin ointment 0.4% to be applied twice a day, every 12 hours.o Group 2 will receive Placebo (ointment that looks like the investigational ointment but contains no active ingredients) to be applied twice a day, every 12 hours.In addition, all participants will be given 2 bottles of paracetemol (generic name for Tylenol®) and will be asked to take 2 tablets (650 mg total) 30 minutes before each ointment application, as a way to help prevent getting a headache (a common side effect of the investigational ointment).Study participants have an equal chance (50%) of being assigned to either Group 1 or Group 2. Neither you nor the study doctor will know which treatment you are receiving. The study is designed this way so researchers can be certain any results are due to the investigational ointment. However, if it becomes necessary for medical reasons, your study doctor is given access to this information.
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Re: Research Study Beginning for Anal Fissures

Postby Guest » 21 Oct 2007, 19:07

Here is the website, they are recruiting all over the US
http://www.analpaintrial.com/
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Re: Research Study Beginning for Anal Fissures

Postby happyass » 21 Oct 2007, 22:03

pain, that is exactly the study. it's the same ad in the paper! just without the website for reference.
i like that the last sentence states that if it becomes necessary for medical reasons, you can find out if you got the real thing or not.
i wonder what effect those tylenol like pills will have for people in either group.
since you are taking a nitro-based ointment, i wonder how this investigational one may differ. hmmmmm.....
***
good luck on your continued healing and thank you for the additional info. it will be very helpful to many here; even in looking for a good CRS.
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Re: Research Study Beginning for Anal Fissures

Postby buttgirl » 22 Oct 2007, 09:36

Lecia wrote:Buttgirl-I wonder if this is that cream you were telling me about a few weeks ago?


that was my first thought. I'll check it out.
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Re: Research Study Beginning for Anal Fissures

Postby dano » 23 Oct 2007, 20:07

damn,where was this last year? typical,year late ,dollar short!
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