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Arena is looking for patients suffering from pain due to IBS

Drug Development

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#1 Robert_Larsson

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Posted 26 July 2019 - 12:50 PM

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About 78% of IBS patients suffer from abdominal pain, a symptom which is often hard to treat and very debilitating for many sufferers as most of you will know.

 

Now Arena Pharmaceuticals has started its Phase 2b clinical trial (NCT04043455) of its IBS-pain drug Olorinab and is looking for participants in the United States. The treatment is for both IBS-C and IBS-D patients who are at least 18 years of age and suffer from frequent abdominal pain due to their IBS. Patients will receive payment for each completed visit which is quite nice. All study medication and study-related care will be provided at no cost to you or your insurance provider for participating in this study. If you would like to read more about this study check out the official homepage https://myibspainstudy.com/

 

Olorinab has already been tested in Phase 1 and Phase 2a clinical trials where it was shown to be safe and well tolerated. The Phase 2a trial saw an average pain reduction of 82% in patients suffering from quiescent Crohn's disease who suffer the same Visceral Hypersensitivity and Pain that IBS patients do. These strong results are the basis for this Phase 2b study Arena is conducting now with an estimate of 240 patients. The first patient has already received Olorinab in this study. 

 

If you would like to participate in this study, get in touch with Arena via their study-page right here https://myibspainstudy.com/ or give them a call at 855-634-0290

 

Payment can reach up to $1,335 for participants during this study, which is a considerable amount.

 

About Olorinab:

Olorinab (APD371) lessens pain by targeting the Cannabinoid Type 2 Receptor (CB2), the same receptor targeted by Cannabidiol (CBD). The compound is peripherally acting and highly selective which means it lacks psychotropic effect. Since Olorinab is a non-narcotic painkiller it holds many advantages to current pain therapies. Additionally the lack of a psychotropic effect means that patients do not suffer any impairment to their mental capacity (it doesn't make patients high) as is the case with several pain therapies currently on the market.

To read more about Olorinab, visit Arena's homepage:

https://www.arenapha...ipeline/apd371/

 

Results from the Phase 2a study here:

http://www.arenaphar...ciated-w-CD.pdf

 

Results from a pre-clinical study by experts in the field:

http://www.arenaphar...imal-Models.pdf

Joel Castro,1 Jessica Maddern,1 Sonia Garcia-Caraballo,1 Amanda Lumsden,1 Beatriz Lindstrom,2 John Adams,2 Stuart M. Brierley1

 

 

The current Phase 2 Trial (NCT04043455) is a "Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study" called CAPTIVATE and will be ongoing as of now at the trial sites across the entire USA. Participants can receive up to $1,335 for participating in this study.

 

If you have any other question i recommend firstly to get in touch with Arena. I will be answering the questions right here to the extent that I can as I am not affiliated with any drug companies or institutions working on this. I hope somebody living in the USA will get some use out of this and maybe help spread the information to patients in pain. 

 

Take care! - Robert


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#2 Robert_Larsson

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Posted 29 July 2019 - 12:23 AM

Thought I should include a comment from a well known IBS-Expert in the field Lin Chang:

"I am thrilled that the first subject has enrolled in Arena's CAPTIVATE trial, supporting the advancement of novel pain management options within the digestive disease field," said Lin Chang, MD, Professor of Medicine at the Vatche and Tamar Manoukian Division of Digestive Diseases at the University of California, Los Angeles. "The majority of IBS patients describe their most problematic symptom as frequent abdominal pain, which often significantly impacts their quality of life.  With limited pain management options available for GI disorders, there is a clear unmet medical need and an opportunity to improve the lives of patients."

 

Source:http://invest.arenap...dosed-captivate


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#3 annie7

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Posted 29 July 2019 - 05:10 AM

thanks for posting all this.  very helpful, as always! 

 

Dr. Chang certainly is right about the unmet need.

 

you might want to also post this in our "Research Studies" forum.  thanks.

 

 

https://www.ibsgroup...search-studies/


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these are just my own thoughts. for expert medical advice please contact a health care professional.


#4 abby_smile

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Posted 01 November 2019 - 02:37 PM

Hi Robert, thank you so much for posting this! I recently spoke to my G.I. about exploring other options for my abdominal pain as no treatments have helped me. He suggested participating in a clinical trial and while scouring the internet for options I came across your thread. I just have a couple of questions I'd like to ask you if it's not too much troublerolleyes.gif

 

I live in Florida and see that there is a trial site recruiting here, do you think I should get in touch with Arena directly or should I give the Research Clinic a call?

 

Does Olorinab have an effect on motility? i suffer IBS-C and wouldn't want to slow down anything further.

 

How long will I be participating in this study if I'm approved?

 

What are my chances of getting a Placebo compared to Olorinab? 

 

Thanks so much again, have a nice evening!



#5 nsmythe88

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Posted 05 November 2019 - 02:37 PM

Contact the Research clinic not Arena. The clinic will give you all the information that you are asking.

 

After that, confirm with your doctor whether the study is right for you.

 

Hi Robert, thank you so much for posting this! I recently spoke to my G.I. about exploring other options for my abdominal pain as no treatments have helped me. He suggested participating in a clinical trial and while scouring the internet for options I came across your thread. I just have a couple of questions I'd like to ask you if it's not too much troublerolleyes.gif

 

I live in Florida and see that there is a trial site recruiting here, do you think I should get in touch with Arena directly or should I give the Research Clinic a call?

 

Does Olorinab have an effect on motility? i suffer IBS-C and wouldn't want to slow down anything further.

 

How long will I be participating in this study if I'm approved?

 

What are my chances of getting a Placebo compared to Olorinab? 

 

Thanks so much again, have a nice evening!



#6 Robert_Larsson

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Posted 05 November 2019 - 05:49 PM

Hi Abby, no trouble I'll point you in the right direction.

 

First you should sign up at the official study page Arena has created right here: https://myibspainstudy.com/   This is a great source of information and they will be able to give you the most up to date research clinics, at this point they might have several recruiting centers in Florida which means there might be one which is closer to you, therefore go to the official page first where you can sign up or give them a call at 855 634 0290. 

 

Now to your questions:

  • Olorinab does not effect motility, which is why the study is open for both IBS-C and IBS-D patients.
  • The period of enrollment will vary but will be at least 12 weeks with another few weeks of preparation. They will give you more information on this if you sign up but you will be paid for each visit to the clinic.
  • Your chances of getting Olorinab are 3:4, where as you will have a 1:4 chance of receiving the Placebo. 

If you have any further questions you can take a look at their official FAQ here: https://myibspainstudy.com/faqs/

Also I recommend getting in touch with them via that website as they have personnel dealing with patients there rather than via the Arena company website. Best of luck to you Abby!


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#7 abby_smile

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Posted 06 November 2019 - 09:59 AM

Thank you so much Robert! My Doctor has given me the thumbs up and I'm now waiting to hear back from Arena. Nothing left to do now but to hope I get enrolled rolleyes.gif  


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