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Crossover in Medical Technology
... additional analysis was conducted censoring follow-up times at the date of crossover to letrozole. In this analysis, a 19% reduction in risk of death (HR=0.81, ... Subsequent analyses were designed to estimate the extent to which the crossover affected the comparative benefit of Femara(1).
With the long-term ...
... pumps by blocking acid production thereby reducing gastric acidity. About the Study This phase I, open-label, randomized, four-period crossover study evaluated the pharmacokinetics of VYVANSE and ADDERALL XR, alone and with Prilosec OTC 40 mg, among 24 healthy adults aged 18 to 45 years. In ...
... (PSG). These outcomes met the predefined objectives of the study. This Phase II trial was a double-blind, placebo controlled, 4-way crossover design comparing placebo to 3 doses of ITI-007 in patients with SMI. Analysis of key therapeutic endpoints in this study indicated that ITI-007 ...
... multiple dosage levels," said Pamela Palmer, M.D., Ph.D., chief medical officer of AcelRx Pharmaceuticals. This 24-patient two-cohort, five-arm crossover study included administration of open-label oral triazolam and IV sufentanil on days one and two followed by a double-blinded, randomized dosing of a ...
... consider treatment options for COPD patients with moderate to severe forms of the disease." This multicenter, randomized, open-label, two-period crossover study was conducted in 109 patients with moderate-to-severe COPD to evaluate the safety and efficacy of twice-daily Perforomist(TM) Inhalation ...
... Following a four-week, open-label, dose-optimization phase with VYVANSE at 30 mg, 50 mg, and 70 mg doses, patients entered a two-week, double-blind, crossover phase where they were randomized into two groups. One group received their optimal dose of VYVANSE the first week and placebo the second week. The ...
... First-in-human data with SPI-256 The primary objective of this Phase 1; randomized, double-blind, placebo-controlled, single- and escalating-dose crossover study was to evaluate the safety, tolerability and pharmacokinetics of single, ascending doses of SPI-256 administered alone or in combination with ...
... -- Relative bioavailability was assessed in 40 patients randomized to naltrexone SR 40mg or naltrexone immediate release (IR) 36mg in a single dose, crossover PK assessment. Analyses revealed that, on a dose-normalized basis, naltrexone SR was associated with a 43.3% lower peak concentration but a ...
... follows the successful completion of two Phase 3 clinical trials. The first Intermezzo(R) Phase 3 trial was a double-blind, placebo-controlled crossover sleep laboratory study of 82 patients, which Transcept believes to be among the largest reported sleep laboratory studies of its type. This objective ...
... and randomized to different treatment sequences for comparison. The study was conducted in a laboratory classroom setting over a 12 hour period. The crossover design exposed each child to five treatments: Focalin XR (20 mg/day and 30 mg/day), Concerta (36 mg/day and 54 mg/day) and placebo. Primary ...
... oral anti-platelet therapy for preventing arterial thrombosis without increasing bleeding risk. The prospective, randomized, blinded, crossover study compared the effects on platelet activation and bleeding time of DG041 alone and in combination with the mainstays of current antiplatelet ...
... withdrawal symptoms. APD125 Phase 2a Study Design The Phase 2a trial of APD125 was a randomized, double-blind, placebo-controlled, three-way crossover study evaluating the safety and efficacy of nighttime dosing in patients with primary insomnia. The trial evaluated standard PSG measurements of ...
... may offer an attractive package." Levemir Shows Comparable Blood Glucose Response versus Glargine The head-to-head, randomized, double-blind crossover study compared the blood glucose response of once-daily Levemir to glargine in a single daily dose over a 24-hour period using continual glucose ...
... the recognized and validated capsaicin-induced pain model, will receive single doses of 90 mg and 150 mg of NGX426 versus placebo in a three-way crossover design. Tezampanel is the first AMPA/kainate-type glutamate receptor antagonist to be studied in clinical trials for chronic pain. Glutamate ...
... to sleep onset vs. placebo. In addition to the Phase 3 outpatient study, Transcept has also completed a Phase 3 double-blind, placebo-controlled crossover sleep-lab study of Intermezzo(R) involving 82 insomnia patients. As announced in June 2007, the sleep-lab study demonstrated that Intermezzo(R) 3.5 ...
... benefit incidence of 67%. -- Patients with an objective response on the Injection product maintained their objective response after crossover to the Injectable Suspension product. Tanespimycin plus trastuzumab was highly tolerable at the recommended Phase 2 dose of 450 mg/m2 ...
... (43.8 percent and 34.4 percent) for ALO-01 whole and morphine sulfate solution, respectively. The second study, a randomized, double-blind, crossover Phase II trial, compared the effects of ALO-01 taken whole (intact orally) with an extended-release morphine sulfate formulation not containing ...
... one FLECTOR(R) Patch every 12 hours for four consecutive days; 12 study subjects received a single 50-mg oral dose of Voltaren(R) in a two-way crossover fashion. Blood was collected at selected times post-dose to determine diclofenac plasma levels. Results indicated that the systemic exposure to ...
... capacity. And with volumetric 3D imaging, six-degree patient positioning, and fine-resolution beam shaping of Elekta Axesse make it a versatile, crossover treatment solution for neuro-oncology. "Elekta is committed to supporting the neurosurgeon by providing highly refined tools that support specific ...
... of Poniard Pharmaceuticals, Inc. Abstract #209. Yee L, Sharma S, Breitz H, Karlin D, Phillips A, Houston S, Saleh M. A phase 1 randomized crossover oral picoplatin bioavailability pharmacokinetics and pharmacodynamics study. To be presented at the Annual Meeting of the American Association for ...
... in platinum resistant cell lines will also be presented at a separate poster presentation. Details are as follows: -- A Phase 1 randomized crossover picoplatin bioavailability pharmacokinetics and pharmacodynamics study. Abstract #209, Session ID: Clinical Research 1; Yee L, Sharma S, ...
... to improve the gastrointestinal safety of antiplatelet therapy. (Logo: http://www.newscom.com/cgi-bin/prnh/20071112/COGENTUSLOGO ) The crossover study (CG106) will characterize the pharmacodynamic effects of CGT-2168 compared with Plavix and will expand earlier findings of comparability. "In a ...
... well-documented null nonresponders, some patients achieved a sustained virologic response (SVR). Overall, 7-14 percent of patients in the boceprevir crossover arms achieved SVR compared to 2 percent in the control arm. SVR was associated with early virologic response and a longer course of therapy (more ...
... patients receiving placebo (P < 0.001 for each comparison versus placebo). Similar response rates were observed in the placebo group 12 weeks after crossover to treatment with ustekinumab. After one additional dose at week 16, responses were maintained through week 28, which is consistent with the ...
PARI LC Plus and PRONEB Ultra Used in Two Perforomist Studies on Improving COPD Therapies
... PARI products as the exclusive nebulizer systems for recent studies comparing maintenance treatments for COPD. Sutherland et al. used an open-label crossover design allowing researchers to catalog patient preferences regarding medication delivery. Patients felt greater treatment satisfaction and perceived ...... pumps by blocking acid production thereby reducing gastric acidity. About the Study This phase I, open-label, randomized, four-period crossover study evaluated the pharmacokinetics of VYVANSE and ADDERALL XR, alone and with Prilosec OTC 40 mg, among 24 healthy adults aged 18 to 45 years. In ...
ADVENTRX Announces Results From ANX-514 Bioequivalence Study
... equivalence of ANX-514 and Taxotere was observed. The bioequivalence study of ANX-514 was an open-label, two-period, randomized, crossover comparison of ANX-514 and Taxotere in patients with advanced cancer potentially sensitive to docetaxel. The primary objective was demonstrating the ...ADVENTRX Completes Patient Enrollment in ANX-514 Bioequivalence Study
... 2007, the aggregate worldwide market for Taxotere was in excess of $3 billion. The study is a multi-center, open-label, randomized two-period crossover comparison of ANX-514 and Taxotere, with a primary endpoint of pharmacokinetic equivalence of ANX-514 and Taxotere and a goal of 28 evaluable ...MannKind Reports Successful Completion of Device Bioequivalence Trial
... costly to manufacture. Clinical trial subjects were administered AFRESA Inhalation Powder from the same bulk lot, according to a randomized two-way crossover protocol, consistent with the standard requirements of bioequivalence testing. As previously announced, this study was requested by FDA at AFRESA's ...... (PSG). These outcomes met the predefined objectives of the study. This Phase II trial was a double-blind, placebo controlled, 4-way crossover design comparing placebo to 3 doses of ITI-007 in patients with SMI. Analysis of key therapeutic endpoints in this study indicated that ITI-007 ...
... multiple dosage levels," said Pamela Palmer, M.D., Ph.D., chief medical officer of AcelRx Pharmaceuticals. This 24-patient two-cohort, five-arm crossover study included administration of open-label oral triazolam and IV sufentanil on days one and two followed by a double-blinded, randomized dosing of a ...
Michael J. Fox Foundation Awards $2.9 Million for Two New Parkinson's Disease Clinical Trials
... information, including grant abstracts and researcher bios, is available at www.michaeljfox.org . A Randomized, Placebo-controlled, Multiple crossover (n-of-1), Pilot trial of Simvastatin on the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients Erwan Bezard, PhD, Universiy ...... consider treatment options for COPD patients with moderate to severe forms of the disease." This multicenter, randomized, open-label, two-period crossover study was conducted in 109 patients with moderate-to-severe COPD to evaluate the safety and efficacy of twice-daily Perforomist(TM) Inhalation ...
... Following a four-week, open-label, dose-optimization phase with VYVANSE at 30 mg, 50 mg, and 70 mg doses, patients entered a two-week, double-blind, crossover phase where they were randomized into two groups. One group received their optimal dose of VYVANSE the first week and placebo the second week. The ...
... First-in-human data with SPI-256 The primary objective of this Phase 1; randomized, double-blind, placebo-controlled, single- and escalating-dose crossover study was to evaluate the safety, tolerability and pharmacokinetics of single, ascending doses of SPI-256 administered alone or in combination with ...
... -- Relative bioavailability was assessed in 40 patients randomized to naltrexone SR 40mg or naltrexone immediate release (IR) 36mg in a single dose, crossover PK assessment. Analyses revealed that, on a dose-normalized basis, naltrexone SR was associated with a 43.3% lower peak concentration but a ...
... follows the successful completion of two Phase 3 clinical trials. The first Intermezzo(R) Phase 3 trial was a double-blind, placebo-controlled crossover sleep laboratory study of 82 patients, which Transcept believes to be among the largest reported sleep laboratory studies of its type. This objective ...
Bronchitol Cystic Fibrosis Dose Trial Results Positive
... of Bronchitol in 48 patients with cystic fibrosis at 12 centres across Canada and Argentina. Bronchitol was administered twice a day for 14 days in a crossover design. Secondary endpoints of the study included other spirometry and quality of life measures. These measures also showed a positive effect for ...... and randomized to different treatment sequences for comparison. The study was conducted in a laboratory classroom setting over a 12 hour period. The crossover design exposed each child to five treatments: Focalin XR (20 mg/day and 30 mg/day), Concerta (36 mg/day and 54 mg/day) and placebo. Primary ...
... oral anti-platelet therapy for preventing arterial thrombosis without increasing bleeding risk. The prospective, randomized, blinded, crossover study compared the effects on platelet activation and bleeding time of DG041 alone and in combination with the mainstays of current antiplatelet ...
... withdrawal symptoms. APD125 Phase 2a Study Design The Phase 2a trial of APD125 was a randomized, double-blind, placebo-controlled, three-way crossover study evaluating the safety and efficacy of nighttime dosing in patients with primary insomnia. The trial evaluated standard PSG measurements of ...
... may offer an attractive package." Levemir Shows Comparable Blood Glucose Response versus Glargine The head-to-head, randomized, double-blind crossover study compared the blood glucose response of once-daily Levemir to glargine in a single daily dose over a 24-hour period using continual glucose ...
... the recognized and validated capsaicin-induced pain model, will receive single doses of 90 mg and 150 mg of NGX426 versus placebo in a three-way crossover design. Tezampanel is the first AMPA/kainate-type glutamate receptor antagonist to be studied in clinical trials for chronic pain. Glutamate ...
... to sleep onset vs. placebo. In addition to the Phase 3 outpatient study, Transcept has also completed a Phase 3 double-blind, placebo-controlled crossover sleep-lab study of Intermezzo(R) involving 82 insomnia patients. As announced in June 2007, the sleep-lab study demonstrated that Intermezzo(R) 3.5 ...
... benefit incidence of 67%. -- Patients with an objective response on the Injection product maintained their objective response after crossover to the Injectable Suspension product. Tanespimycin plus trastuzumab was highly tolerable at the recommended Phase 2 dose of 450 mg/m2 ...
ADVENTRX Announces ANX-530 Safety Data From Registrational Bioequivalence Clinical Study
... at the site of injection. Adverse events were graded based on the investigator's assessment of severity. The bioequivalence study of ANX-530 was a crossover comparison of ANX-530 and Navelbine with a primary objective of demonstrating the pharmacokinetic equivalence of ANX-530 and Navelbine. Determining ...... (43.8 percent and 34.4 percent) for ALO-01 whole and morphine sulfate solution, respectively. The second study, a randomized, double-blind, crossover Phase II trial, compared the effects of ALO-01 taken whole (intact orally) with an extended-release morphine sulfate formulation not containing ...
... one FLECTOR(R) Patch every 12 hours for four consecutive days; 12 study subjects received a single 50-mg oral dose of Voltaren(R) in a two-way crossover fashion. Blood was collected at selected times post-dose to determine diclofenac plasma levels. Results indicated that the systemic exposure to ...
Go Healthy Initiates Additional Clinical Tests on Cholesterade
... on Techniques to Enhance Human Performance and has served on a number of NIH and NIMH advisory committees. The study will be a double-blind crossover study of the efficacy of Cholesterade(R) in lowering cholesterol (total cholesterol and LDL) and triglycerides while increasing HDL and HDLC/LDLC ...... capacity. And with volumetric 3D imaging, six-degree patient positioning, and fine-resolution beam shaping of Elekta Axesse make it a versatile, crossover treatment solution for neuro-oncology. "Elekta is committed to supporting the neurosurgeon by providing highly refined tools that support specific ...
... of Poniard Pharmaceuticals, Inc. Abstract #209. Yee L, Sharma S, Breitz H, Karlin D, Phillips A, Houston S, Saleh M. A phase 1 randomized crossover oral picoplatin bioavailability pharmacokinetics and pharmacodynamics study. To be presented at the Annual Meeting of the American Association for ...
Parion Sciences Announces Phase I Clinical Results for Novel Dry Mouth Treatment
... Annual Meeting of the American Association for Dental Research. The trial was a 28-day, 30-patient, randomized, double-blind, placebo- controlled, crossover study designed to assess the effect of a six-time daily oral rinse formulation of P-552-02 versus placebo on oral and systemic safety parameters and ...Neutropenia: Biosimilar Product from India Moves One Step Closer to European Market
... with identical kinetics after treatment. We are very pleased with these results." The study was a single-dose, randomised, double-blind, two-way crossover trial and used an active control. The trial involved 36 patients and was carried out by Prof. Bernd Jilma, MD, of the Medical University of Vienna ...Low Acid Coffee Backed By Scientific Research
... from those consumers who don't experience stomach problems from coffee. This is important for the company as it seeks to achieve "crossover" status - crossover products are those that satisfy both the consumer with the health issue and those only interested in taste. "These expanded studies will help us ...... in platinum resistant cell lines will also be presented at a separate poster presentation. Details are as follows: -- A Phase 1 randomized crossover picoplatin bioavailability pharmacokinetics and pharmacodynamics study. Abstract #209, Session ID: Clinical Research 1; Yee L, Sharma S, ...
Study Compares Bronchodilatory Effects of SYMBICORT(R) and Advair in Adults With Asthma
... Study Results (Abstract #859) Bronchodilatory response rate was investigated in two identically designed, multicenter, single-dose, four-period crossover studies. The studies were conducted in 109 patients (SD-039-0732, N=55; SD-039-0733, N=54) ages 18 years and older with mild to moderate asthma ...Synbiotics Corporation Announces Human Submission for FluDetect(R)
... sensitivity in a simple to use test format that requires no equipment, nor extensive training to perform. Management believes this may be the first crossover test to be licensed for use both in humans and animals and can be a vital tool to healthcare institutions for both seasonal flu testing as well as in ...... to improve the gastrointestinal safety of antiplatelet therapy. (Logo: http://www.newscom.com/cgi-bin/prnh/20071112/COGENTUSLOGO ) The crossover study (CG106) will characterize the pharmacodynamic effects of CGT-2168 compared with Plavix and will expand earlier findings of comparability. "In a ...
Surface Logix Achieves Objectives With SLx-2101 in Phase 2a Clinical Trial in Hypertension
... of potency and an extended duration of action. About the trial: The Phase 2a study of SLx-2101 was a randomized, double-blind, placebo-controlled crossover trial, and was conducted at two centers in Europe. A total of 60 patients with uncontrolled hypertension, who were concurrently taking up to 3 ...ADVENTRX Meets Primary Endpoint in ANX-530 Marketing-Enabling Clinical Study
... annual sales of Navelbine and generic vinorelbine in 2006 were approximately $200 million. The bioequivalence study of ANX-530 was a crossover comparison of ANX-530 and Navelbine with a primary objective of demonstrating the pharmacokinetic equivalence of ANX-530 and Navelbine. Determining ...... well-documented null nonresponders, some patients achieved a sustained virologic response (SVR). Overall, 7-14 percent of patients in the boceprevir crossover arms achieved SVR compared to 2 percent in the control arm. SVR was associated with early virologic response and a longer course of therapy (more ...
ADVENTRX Announces Completion of Patient Enrollment in ANX-530 Marketing-Enabling Clinical Study
... our NDA timeline for ANX-530 following that meeting." ANX-530 is currently being tested in a 28-patient bioequivalence study. The study is a crossover comparison of ANX-530 and Navelbine, also available as generic vinorelbine, with a primary endpoint of pharmacokinetic equivalence of ANX-530 and ...... patients receiving placebo (P < 0.001 for each comparison versus placebo). Similar response rates were observed in the placebo group 12 weeks after crossover to treatment with ustekinumab. After one additional dose at week 16, responses were maintained through week 28, which is consistent with the ...
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(Date:11/26/2009)...er 26, 2009) Whitehead researchers have developed...inpoint specific genes and proteins used by pathog... most human cell cultures genes are present in two...m the mother. Gene inactivation by mutation is the...vated, the second copy usually remains active and ...
(Date:11/26/2009)...ant Staphylococcus Aureus ) and other drug-resist...ature plasma prototype devices have been developed...idal cocktails. , Two prototype devices have bee...lthy skin (e.g. hands and feet) in hospitals and p...at; and another to shoot bacteria-killing agents i...
(Date:11/25/2009)...ced in the stomach, may be used to boost resistanc...ase, Yale School of Medicine researchers report in...al of Neuroscience . , Parkinson,s disease is ca...rea of the midbrain known as the substantia nigra,...duced production of dopamine in late-stage Parkins...
Breaking Biology News(10 mins):Knockouts in human cells point to pathogenic targets 2Plasma produces KO cocktail for MRSA 2Plasma produces KO cocktail for MRSA 3Hormone ghrelin can boost resistance to Parkinson's disease 2Emerson Ecologics Expands Their Team of Naturopathic Doctors 51718 1Emerson Ecologics Expands Their Team of Naturopathic Doctors 51718 2Vasogen Announces Second Quarter 2009 Results 13030 1Vasogen Announces Second Quarter 2009 Results 13030 2Vasogen Announces Second Quarter 2009 Results 13030 3Vasogen Announces Second Quarter 2009 Results 13030 4Vasogen Announces Second Quarter 2009 Results 13030 5Vasogen Announces Second Quarter 2009 Results 13030 6Vasogen Announces Second Quarter 2009 Results 13030 7Vasogen Announces Second Quarter 2009 Results 13030 8Vasogen Announces Second Quarter 2009 Results 13030 9Vasogen Announces Second Quarter 2009 Results 13030 10Educated Parkinsons Patients Move to Meds Sooner 51713 1Educated Parkinsons Patients Move to Meds Sooner 51713 2(Date:12/1/2009)...e gestational glucose intolerance (a condition les...le cardiovascular risk factors as early as three m...ed for publication in The Endocrine Society,s Jou...M ). , Researchers in this study sought to eval...intolerance and postpartum risk of metabolic syndr...
(Date:12/1/2009)...Centers for Disease Control (CDC) estimates that 1... an autism spectrum disorder. These children can l...sing by playing the new therapeutic PC video game ...., a wonderful holiday gift idea for a child on th...a, MD (PRWEB) December 1, 2009 -- The new therapeu...
(Date:12/1/2009)...Newswire/ - Sentinelle Medical Inc., a leading man...alization software, extends its line of award winn...ty of North America (RSNA) annual meeting in Chica..., With the unique Vanguard(R) patient support d...Sentinelle,s line of breast coils are recognized f...
(Date:12/1/2009)...giving: Ready or Not helps families prepare for an... Cincinnati, Ohio (PRWEB) December 2, 2009... to help families understand and embrace the chall... our loved ones live long, healthy and prosperous ...e at some point, and their needs often become evid...
(Date:12/1/2009)... hearing aids will be given by Estes Audiology to ... Austin, TX (PRWEB) December 1, 2009 -...fessional hearing healthcare provider dedicated to...heir families, announced today the beginning of it... Each year, Estes Audiology donates two pairs of h...
Breaking Medicine News(10 mins):Health News:Glucose intolerance in pregnancy associated with postpartum cardiovascular risk 2Health News:EASe Funhouse Video Game Helps Children with Autism Learn to Improve Sensory Processing 2Health News:EASe Funhouse Video Game Helps Children with Autism Learn to Improve Sensory Processing 3Health News:EASe Funhouse Video Game Helps Children with Autism Learn to Improve Sensory Processing 4Health News:Sentinelle Medical Introduces New Suite of Breast MRI Coils for GE, Siemens and Toshiba Scanners 2Health News:Sentinelle Medical Introduces New Suite of Breast MRI Coils for GE, Siemens and Toshiba Scanners 3Health News:Aging Expert's New Book Helps Boomers Address Challenges of Caregiving 2Health News:Estes Audiology Offers the Gift of Hearing to Celebrate the Holiday Season 2[0] Glucose intolerance in pregnancy associated with postpartum cardiovascular risk[0] EASe Funhouse Video Game Helps Children with Autism Learn to Improve Sensory Processing[0] Sentinelle Medical Introduces New Suite of Breast MRI Coils for GE, Siemens and Toshiba Scanners[0] Aging Expert's New Book Helps Boomers Address Challenges of Caregiving[0] Estes Audiology Offers the Gift of Hearing to Celebrate the Holiday Season
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