RxPG News : Clinical Trials

Probiotics unsafe for severe acute pancreatitis patient's due to its increased mortality.

Thu, 14 Feb 2008 07:00:00 PST

Probiotics are associated with an increased mortality in patients with severe acute pancreatitis, and do not reduce the risk of infectious complications in these patients. These are the conclusions of authors of an Article published early Online and in an upcoming edition of The Lancet.

Start of Second Phase III Trial in MS Neuropathic Pain

Wed, 09 Aug 2006 14:46:00 PST

GW Pharmaceuticals plc (AIM: GWP) announces the start of a second pivotal Phase III trial in people with multiple sclerosis (MS) suffering from central neuropathic pain. The first patient has now been enrolled in the study.

RISUG (Reversible Inhibition of Sperm Under Guidance) Trial to recruit more volunteers

Fri, 31 Mar 2006 12:43:00 PST

The trial is studying a new male contraceptive, RISUG (Reversible Inhibition of Sperm Under Guidance): a reversible, nonhormonal contraceptive that provides 10 or more years of protection after a 10-15 minute procedure. Researchers received approval this week to begin enrolling additional study volunteers, after a delay of nearly four years.

EU clinical trials directive is threatening future of cancer research

Sat, 04 Mar 2006 15:14:00 PST

A new European directive is threatening the future of cancer research in Europe, warn experts in this weeks BMJ. The EU clinical trials directive, implemented in 2004, was intended to protect patients and improve research standards. But many investigators were worried that the labour intensive, bureaucratic, and expensive endeavour of running a clinical trial would become worse under the new rules. In particular, academic researchers funded by grants, who have so far performed most cancer trials, were worried that their resources might no longer suffice to meet the requirements of the new directive.

Lessons from natalizumab fast tracking in multiple sclerosis

Fri, 17 Feb 2006 19:05:00 PST

Concerns over the fast tracking of new drugs for commercial licensing are raised by a senior doctor in this weeks BMJ. It follows approval of natalizumab, a new drug for multiple sclerosis, and its recall three months later, after three trial patients developed a life threatening condition while being treated. Natalizumab was licensed by the US Food and Drug Administration in 2004 for use in relapsing multiple sclerosis on the basis of short term results from two unpublished trials. The FDA granted approval before final trial and cumulative safety data were available. Natalizumab was predicted to be the leading drug for multiple sclerosis, with estimated annual sales in excess of $2bn.

First human trial of recombinant ricin vaccine completed

Tue, 31 Jan 2006 19:54:00 PST

Scientists have completed the first human clinical trial of a recombinant vaccine for the deadly toxin ricin - a potential bioterror threat and the results indicate the vaccine is safe and effective in eliciting ricin-neutralizing antibodies, the UT Southwestern Medical Center researchers report.

New stem cell study seeks to prevent heart failure

Tue, 24 Jan 2006 18:12:00 PST

University of Rochester Medical Center researchers today announced the launch of a study that will examine whether transplanted stem cells can be safely used to treat damaged heart muscle in patients just after their first heart attack. As part of the fast emerging science of regenerative medicine, labs worldwide are attempting to replace damaged tissue with new cells, much in the same way as salamanders re-grow limbs.

Electronic health record-based clinical trial alert system increased recruitment rates

Tue, 25 Oct 2005 05:16:00 PST

An electronic health record-based clinical trial alert system increased recruitment rates and physicians' participation in an ongoing clinical trial, according to a study in the October 24 issue of the Archives of Internal Medicine, one of the JAMA/Archives journals.

Study of New, Non-Growth Hormone Treatment for Short Stature

Tue, 13 Sep 2005 21:05:00 PST

Rush University Medical Center is participating in a clinical trial to evaluate the potential benefit of the first major innovation in 20 years for the treatment of growth failure. The drug, called Increlex, was approved by the FDA August 31 for the most severe form of short stature due to a deficiency of Insulin-like Growth Factor-1 (IGF-1). Ongoing trials will determine if the drug may be used for less severe growth disease.