Validating clinical trial data. Food and Supplement Clinical Trial Services.



Validating clinical trial data

Validating clinical trial data

Our Pipeline A Novel Approach to Treating Pain Our clinical pipeline consists of novel, non-opioid pain therapies aimed at new or emerging pharmacological targets selectively interrupting pain transmission pathways to more effectively treat moderate to severe chronic pain without risks of dependence or abuse.

We are studying our therapies in companion animals with the same naturally-occurring, pain-causing disease conditions that are common to both humans and animals. By validating the safety and therapeutic effect of our treatments in both humans and animals, we are able to work on parallel tracks to develop human and veterinary treatments. The Heritage of Capsaicin Capsaicin is a naturally-occurring compound found in chili peppers that has been safely used as a spice and medicine for centuries.

Capsaicin has been used as an over-the-counter topical analgesic for decades, to provide temporary relief from mild-to-moderate pain associated with common conditions including osteoarthritis and neuropathic pain. It harnesses the natural analgesic power of capsaicin to develop a proprietary injectable therapy designed to provide fast-acting, long-lasting and targeted pain relief.

OA occurs when the protective cartilage on the ends of the bones wears down over time, and the bones around the joints harden and form edges. These changes cause pain, swelling and difficulties moving the joint. OA also causes an inflammatory process to occur in the affected joint, further damaging the cartilage. Despite currently available therapies that temporarily address OA pain, many patients must resort to total joint replacement to address this painful condition.

Through its targeted delivery and highly-selective method of action, CNTX manages pain without disrupting other nerve functions. FDA in January The trial showed that patients receiving CNTX experienced a rapid and highly statistically significant reduction in pain that occurred within days and lasted at least six months.

Twenty-two percent of patients treated with CNTX achieved a 90 percent or greater reduction in pain and 67 percent of patients achieved 50 percent or greater reduction in pain. Treatment with CNTX produced a rapid and statistically significant in reduction in pain that lasted until the end of the 12 week trial in a post hoc analysis. With a short half-life, CNTX is cleared from the body within 24 hours. This approach provides pain relief that can last for months until the ends of the local pain fibers regenerate, while leaving the rest of the nerve fiber functioning as normal.

Your browser does not support the video tag. TRPV1 expressing neurons after exposure to capsaicin. Recent studies have shown a close link between chronic pain and the immune system. CNTX capitalizes on this connection by taking a novel neuro-immune approach. The compound has a dual effect: Based on our extensive big data analytics and research, CNTX is predicted to be well suited to treat chronic painful inflammatory conditions such as osteoarthritis.

CNTX is in development to treat inflammatory pain and data to date have shown that CNTX is safe and well tolerated and has demonstrated pharmacologic activity evidenced by target engagement. It is 20, times more selective for the CB2 receptor than the CB1, and thereby able to achieve pain relief without psychotropic and other side effects seen with less selective agonists.

CNTX works by activating the SSTR4 receptor, which functions as a master control switch to turn down the activity of several other pain receptors, such as specific calcium channels, potassium channels and TRPV1 and TRPA1 channels, thereby reducing the transmission of pain signals.

CNTX has shown activity in every chronic pain model it has been tested in to date. Based on our big data analytics, we believe it has promise in treating a wide variety of chronic pain conditions and could be especially valuable for mixed pain, such as chronic back pain.

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FDA Official Validation Rules for Submission Data



Validating clinical trial data

Our Pipeline A Novel Approach to Treating Pain Our clinical pipeline consists of novel, non-opioid pain therapies aimed at new or emerging pharmacological targets selectively interrupting pain transmission pathways to more effectively treat moderate to severe chronic pain without risks of dependence or abuse.

We are studying our therapies in companion animals with the same naturally-occurring, pain-causing disease conditions that are common to both humans and animals. By validating the safety and therapeutic effect of our treatments in both humans and animals, we are able to work on parallel tracks to develop human and veterinary treatments.

The Heritage of Capsaicin Capsaicin is a naturally-occurring compound found in chili peppers that has been safely used as a spice and medicine for centuries. Capsaicin has been used as an over-the-counter topical analgesic for decades, to provide temporary relief from mild-to-moderate pain associated with common conditions including osteoarthritis and neuropathic pain. It harnesses the natural analgesic power of capsaicin to develop a proprietary injectable therapy designed to provide fast-acting, long-lasting and targeted pain relief.

OA occurs when the protective cartilage on the ends of the bones wears down over time, and the bones around the joints harden and form edges. These changes cause pain, swelling and difficulties moving the joint. OA also causes an inflammatory process to occur in the affected joint, further damaging the cartilage.

Despite currently available therapies that temporarily address OA pain, many patients must resort to total joint replacement to address this painful condition. Through its targeted delivery and highly-selective method of action, CNTX manages pain without disrupting other nerve functions. FDA in January The trial showed that patients receiving CNTX experienced a rapid and highly statistically significant reduction in pain that occurred within days and lasted at least six months.

Twenty-two percent of patients treated with CNTX achieved a 90 percent or greater reduction in pain and 67 percent of patients achieved 50 percent or greater reduction in pain. Treatment with CNTX produced a rapid and statistically significant in reduction in pain that lasted until the end of the 12 week trial in a post hoc analysis. With a short half-life, CNTX is cleared from the body within 24 hours.

This approach provides pain relief that can last for months until the ends of the local pain fibers regenerate, while leaving the rest of the nerve fiber functioning as normal.

Your browser does not support the video tag. TRPV1 expressing neurons after exposure to capsaicin. Recent studies have shown a close link between chronic pain and the immune system. CNTX capitalizes on this connection by taking a novel neuro-immune approach. The compound has a dual effect: Based on our extensive big data analytics and research, CNTX is predicted to be well suited to treat chronic painful inflammatory conditions such as osteoarthritis.

CNTX is in development to treat inflammatory pain and data to date have shown that CNTX is safe and well tolerated and has demonstrated pharmacologic activity evidenced by target engagement.

It is 20, times more selective for the CB2 receptor than the CB1, and thereby able to achieve pain relief without psychotropic and other side effects seen with less selective agonists. CNTX works by activating the SSTR4 receptor, which functions as a master control switch to turn down the activity of several other pain receptors, such as specific calcium channels, potassium channels and TRPV1 and TRPA1 channels, thereby reducing the transmission of pain signals.

CNTX has shown activity in every chronic pain model it has been tested in to date. Based on our big data analytics, we believe it has promise in treating a wide variety of chronic pain conditions and could be especially valuable for mixed pain, such as chronic back pain.

Validating clinical trial data

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4 Comments

  1. It is 20, times more selective for the CB2 receptor than the CB1, and thereby able to achieve pain relief without psychotropic and other side effects seen with less selective agonists. Exploring a new method for developing patient-centered clinical trials Using patient preference information to set the significance level and power of a clinical trial can maximize the value of a clinical trial based on the relative importance of benefit and risk outcomes to a specific patient population. FDA in January

  2. Intertek can provide support for your food or supplement clinical trials from start to finish, including study design, placement, management, monitoring, and manuscript writing.

  3. The Heritage of Capsaicin Capsaicin is a naturally-occurring compound found in chili peppers that has been safely used as a spice and medicine for centuries. This approach provides pain relief that can last for months until the ends of the local pain fibers regenerate, while leaving the rest of the nerve fiber functioning as normal.

  4. The use of surrogate or simulated samples can foster innovation when clinical specimens are difficult to obtain or retain. The explicit incorporation of patient preferences into clinical trial design will address the longstanding conundrum that, in an enterprise devoted to easing the burden of disease, the afflicted currently have no input into the process.

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