# New prokinetic in C.trial for IBS-C



## SpAsMaN* (May 11, 2002)

http://www.dynogen.com/pipeline_gi.htm


> quote: DDP733 Dynogen is studying DDP733 as a therapy for both constipation-predominant IBS (IBS-c) and nocturnal gastroesophogeal reflux disease (N-GERD).In October 2004, we in-licensed pumosetrag, known as DDP733, into our pipeline from Mitsubishi Pharma Corporation. DDP733 is a locally-acting 5-HT3 receptor partial agonist with established prokinetic properties. Mitsubishi conducted human trials with DDP733 through Phase II, where it demonstrated clean and favorable safety and pharmacokinetic profiles.DDP733 shows promise as a motility enhancer of the GI tract. Dynogenâ€™s license includes exclusive rights to all preclinical, clinical and manufacturing data related to DDP733, in addition to issued patents and pending patent applications.


 For canadian C-sufferers:http://www.clinicaltrials.gov/ct/show/NCT00215566?order=11


----------



## SpAsMaN* (May 11, 2002)

Microbia:http://www.clinicaltrials.gov/ct/show/NCT00258193?order=7


----------



## SpAsMaN* (May 11, 2002)

> quoteDP733 Dynogen is studying DDP733 as a therapy for both constipation-predominant IBS (IBS-c) and nocturnal gastroesophogeal reflux disease (N-GERD).


I HAVE AN APPOINTMENT IN 10 DAYS WITH THE DOCTOR IN CHARGE OF THIS C.TRIAL.


----------



## SpAsMaN* (May 11, 2002)

Renzapride:http://www.biospace.com/news_story.aspx?St...20553020&full=1Alizyme PLC (AZM.L) Reaches Agreement With FDA For Renzapride Phase III Clinical Trial Cambridge UK, 7 July 2005: Alizyme plc (LSE:AZM) announces that it has reached agreement with the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure for the design of a pivotal Phase III clinical trial for renzapride in constipation-predominant irritable bowel syndrome (c-IBS) in the US. The trial will be a multi-centre, randomised, double-blind, placebo-controlled, parallel group, pivotal, efficacy study. The trial will involve up to 1,700 women with c-IBS being treated over a 12-week period. Patients' response will be determined by each patient, via weekly self-assessments of their IBS symptoms. The primary endpoint will be to evaluate whether daily doses of renzapride, taken either as 4 mg once daily or 2 mg twice daily, are clinically and statistically significantly more effective than placebo in providing overall symptomatic relief of c-IBS in women between 18 and 65 years of age. Secondary endpoints include adequate relief of abdominal pain/discomfort and of bowel problems. It is expected that patient recruitment will commence in Q4 2005 and, assuming anticipated recruitment timelines are met, Alizyme would expect results to be available in the first half of 2007. Commenting, Dr Richard Palmer, Chief Executive Officer, said: "We are extremely pleased to have reached agreement with the FDA, following extensive discussions, for this pivotal Phase III clinical trial of renzapride in the US. This is a major achievement for both renzapride and the Company as it takes a second product from our portfolio into Phase III clinical development." Further information on Alizyme can be found on the Company's website: www.alizyme.com


----------



## 21078 (Oct 1, 2005)

So, Spasman, I'm confused, as usual. Is Pumosetrag (DDP733) the same drug as Renzapride? Or, are they just both prokinetics which is why you have them together in one thread? What happened when you when for the C trial? Are you in? How's it going?Dave


----------



## SpAsMaN* (May 11, 2002)

Well i "didn't met" the inclusion criteras.That's what the doc told me to get rid of me.







You don't want a better doc than you in the same office.


----------

