DARA BioSciences announces successful phase II trial results for KRN5500, for cancer pain

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Researchers study new drugs for neuropathic pain one interesting findings have reported response of a Phase 2a proof-of-concept study compared to placebo response. They presented their findings in a poster session at the 2011 International Conference to speed up the development of enhanced pain treatments.

Their results could in future similar pain medication studies to result in more accurate results. In clinical pain studies are either evaluated the drug or an identically appearing placebo given, then report on whether the drug it their pain helped by rating on a scale from 0 to 10. Because pain is such subjective symptom, self-disclosure that researchers can determine the only way the degree of pain therapy is patient.

Subjective results can be difficult to assess.

In her presentation reported Moore PhD, Susan E. Spruill PStat and Linda G. Jett MSN, the results of a study to evaluate the safety of k. researcher Christine and safety of new drugs, KRN5500, developed by DARA BioSciences Raleigh, NC. In earlier studies by the National Cancer Institute, the drug KRN5500 showed promise for the relief of neuropathic pain, which often afflicts cancer patients. It is common that patients react on the placebo in pain studies in subjective result, data is collected. Researchers are often faced with a dilemma: the drug is a failure or the placebo response is too big, see the response?

According to Dr. Moore is "one of the most important problems in clinical trials of analgesics, that it often is not enough difference between the drug and placebo because the placebo response is so high." Patients want to feel better. "The placebo effect can require as 40 to 50 percent, a greater drug effect on a difference shows amount."

We want to feel better, so we delude ourselves

Mrs Spruill, the study statistician, said: "the problem is that there is always a reply placebo." This is because as a human being, we can manifest a psychological and/or physical reaction, even if it no real treatment. This effect can be made not forever, but we can certainly be tricked for a short time. "Pain is one of the areas in which we well to bring ourselves are." The placebo response should really be regarded as background noise, the team suggests. What are looking for, is a researcher, a clinical use of what is in this background ", which is why we need to study the drug effects parallel to a placebo," adds Mrs. Spruill.

It was really the drug

Although 19 patients had this particular study, it had a low placebo response, select the results must be interpreted easily. Dr. Moore said the study was first developed to assess the safety profile of the drugs, and secondly could pain evaluate response to potential "signal, the" have a positive effect. They have more than they expected; They found in this study, that KRN5500 was actually both statistically and clinically significant relief to reach its primary endpoint reduction of the pain of baseline in neuropathic pain. Decreased the patients who took the drug to their pain scores average: 2 units on a numeric rating scale, while patients, which the placebo took little until showed no change in their pain scores. In addition, all patients in this study were already on other medication for their pain; They took the study drug in addition to their usual pain management.

The researchers now more search in the experimental and clinical implementation of this study as they try to understand why such a small study was so successful. You believe that one of the reasons, it was a low placebo response is that patients were very sick and experienced "Neuropathic pain change life." The patients were ready to participate get she may know the placebo was it a way and agreed, try to stay in the study for at least 4 and up to 8 weekly doses over a period of 10 weeks. Patients instead of no false hopes, that would the drug to cure her cancer and understood that it received is only for the treatment of pain and improving the quality of life, which can lead. More studies of the KRN5500 are planned.

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DARA BioSciences