Phase III Clinical Studies of Aclidinium Bromide Show Statistical Significance vs. Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NEW YORK, Sept. 3 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX ) and Laboratorios Almirall, S.A. today announced results from two global Phase III studies of aclidinium bromide, a novel long-acting inhaled anticholinergic for the treatment of patients with chronic obstructiv...

Controversy About Lack of Placebo Group Decline in Alzheimer's Clinical Trials

- Two Large-Scale Analyses Have Conflicting Results - CHICAGO, July 28 /PRNewswire-USNewswire/ -- Lack of measureable decline in memory and thinking processes among placebo groups in Alzheimer's disease clinical trials might reduce the ability to show the effectiveness of new Alzheimer thera...

New Study Results Show Asenapine More Effective Than Placebo in the Treatment of Acute Schizophrenia

KENILWORTH, N.J., Dec. 17 /PRNewswire-FirstCall/ -- Schering-Plough Corporation (NYSE: SGP ) today reported on new study results that demonstrated that Asenapine, a fast-dissolving, sublingual tablet being developed for treatment of schizophrenia, was more effective than placebo and well tole...

Review of Probiotic Trial Research Finds Only Bifantis(R) Able to Claim Efficacy versus Placebo for IBS Symptoms

Of 13 studies analyzed, only Bifantis used appropriate study design to demonstrate efficacy compared with placebo PHILADELPHIA, Oct. 15 /PRNewswire/ -- A new analysis of randomized controlled trials evaluating probiotics in the treatment of irritable bowel syndrome (IBS) has fou...

New Study of Concerta(R) Showed Significant Improvement of ADHD Symptom Management in Adults Compared to Placebo

Interim Results From Open-Label Follow-up Include Longer-term Safety Findings BOSTON, Oct. 26 /PRNewswire/ -- Adults with Attention Deficit Hyperactivity Disorder (ADHD) treated with CONCERTA(R) OROS(R) methylphenidate HCl Extended-release Tablets showed signif...

New Long-Term Data Analyses for Bifeprunox Show Favorable Effects Versus Placebo in Stabilized Patients with Schizophrenia

Six-Month Data Show Bifeprunox Maintained Stability Significantly Longer than Placebo and had a Favorable Weight and Lipid Profile Comparable with Placebo MARIETTA, Ga. and COLLEGEVILLE, Pa., May 22, 2007 - Solvay Pharmaceuticals, Inc., Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), and ...

Safety Analyses of Clinical Data for Bifeprunox in Patients with Schizophrenia Showed a Favorable Weight and Lipid Profile, Similar to Placebo

COLLEGEVILLE, Pa., March 30, 2007 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth , Solvay Pharmaceuticals, Inc. and Lundbeck A/S presented clinical study results on bifeprunox at an international medical congress this week. Safety analyses suggest bifeprunox, an investigation...

Pooled Studies Showed Desvenlafaxine Succinate Significantly Improved Painful Symptoms and Anxious Symptoms Associated with Major Depressive Disorder in Adults, Compared With Placebo

Pooled Findings Presented at 2007 APA Meeting Also Showed No Significant Impact on Weight for Desvenlafaxine Succinate COLLEGEVILLE, Pa., May 21, 2007 /PRNewswire-FirstCall/ -- Findings from two separate pooled analyses - one examining the effect of desvenlafaxine succinate on anxious symptoms and...

Data Presented at SLEEP 2007 Shows VEC-162 Improves Sleep Onset and Maintenance vs. Placebo

Demonstrates Positive Effect on Objective and Subjective Sleep Measures MINNEAPOLIS, June 13, 2007 /PRNewswire-FirstCall/ -- According to study results presented today at SLEEP 2007, the 21st annual meeting of the Associated Professional Sleep Societies (APSS), VEC-162, a balanced melatonin (MT1/M...

Isis Reports Strong Financial Results and Highlights for Second Quarter of 2009

...eduction in LDL-C after 26 weeks of treatment with mipomersen versus 3% for placebo and all of its secondary endpoints in a highly statistically significant ma...oint, with a 25% reduction in LDL-C after 26 weeks of treatment, vs. 3% for placebo (p<0.001). The study also met each of its three secondary endpoints of ...

Radius' Investigational Bone Anabolic Agent, BA058, Increased Bone Mineral Density (BMD) at Key Fracture Sites in Phase 2 Clinical Trial in Postmenopausal Osteoporosis

...ncreased mean lumbar spine BMD by 6.7 percent compared with 1.6 percent for placebo and significantly boosted mean femoral neck BMD by 3.1 percent compared with 0.8 percent for placebo at six months for the highest dose tested. By comparison, the mean percent ...

Labopharm files New Drug Submission with Health Canada for novel antidepressant

...e positive results from a North American Phase III placebo controlled clinical trial (study 04ACL3-001), whic...end of the study in the trazodone group versus the placebo group. Statistical significance was achieved for t...odone demonstrated significant improvements versus placebo in all three quality of sleep end points, with an ...

TWO NEW KLRI PEER-REVIEWED PUBLICATIONS: Hormone Therapy May Reduce Atherosclerosis in Women Close to Menopause; Growth Hormone May Increase Risk of Diabetes, Improve Lipid Profile in Men

...menopausal Estrogen/Progestin Interventions (PEPI) trial compared conjugated equine estrogen (CEE) with three different CEE-progestin combinations and placebo in 875 healthy, postmenopausal women, aged 45 to 64. KLRI has found that other trial results used by the FDA, American Heart Association and other gro...

Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

... placebo. INVEGA(R) SUSTENNA(TM) was superior to placebo in improving positive and negative syndrome scale ...ials and significantly delayed time to relapse vs. placebo in the longer-term maintenance study. The m...elapse (10% [n=15/156]) compared with those in the placebo group (34% [n=53/156]). Because maintenanc...

Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of Hepatitis C

...ients were randomized to receive either PSI-7851 (8 patients per cohort) or placebo (2 patients per cohort). Three dose cohorts of PSI-7851 (50mg QD, 100mg QD,...0.61 200mg QD 8 -1.01 placebo 6 -0.03 ----------------...

Dirucotide Does Not Meet Primary Endpoint in Phase III MAESTRO-01 Trial in Secondary Progressive Multiple Sclerosis

... there were no statistically significant differences between dirucotide and placebo on the secondary endpoints of the study. The data also showed that d...in Europe and included 612 patients being administered either dirucotide or placebo intravenously every six months for a period of two years. The primar...

Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms

...rine bleeding was not statistically different from placebo and the rate of endometrial hyperplasia in doses b...t significantly different from those reported with placebo over two years of study. 2. Bazedoxifene/...s with BZA/CE was not statistically different from placebo over two years of therapy. 3. Evaluation ...

Unlikely Treatment Identified by BrainCells Neurogenesis Platform Improved Clinical Outcomes in Patients Suffering From Depression

...of three arms, BCI-952 (n=67), buspirone (n=34) or placebo (n=33). Co-primary endpoints were the Clinical Glo...I at week six demonstrated improvement relative to placebo using the MITT LOCF, MITT MMRM. The mean CGI-I scores were statistically significant relative to placebo using the MITT MMRM (p=0.046).The responders analy...

R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent

..., ACR 50, ACR 70 and DAS28 response rates than the placebo group at three months, and therefore, the trial fa...ted range in this patient population, the reported placebo response rates were considerably higher than seen ...point the reported response rates between R788 and placebo were significantly different) and month 3 (when su...

R-Tech Ueno, Ltd. Completes Phase 1 Clinical Study on RK-023

...on was applied to the vertex region of 6 out of 9 healthy adult males and a placebo to that of the remaining 3 subjects. The applied drug was spread widely cov...se study, in the morning and at night 2 ml of RK-023 preparation or 2 ml of placebo was applied to 6 and 2 out of 8 healthy adult males respectively. No seriou...

Idenix Pharmaceuticals Successfully Completes Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV)

...afety and antiviral activity of IDX184. In this study, 41 treatment-naive HCV genotype-1-infected patients were randomized to receive either IDX184 or placebo once-daily for three days. Four dosing cohorts (25 mg, 50 mg, 75 mg and 100 mg) of IDX184 were evaluated. IDX184 was well tolerated in this study with...

First Potential Lupus-Specific Treatment in Sight

...ovement in overall disease activity without clinically significant flare-ups in one or more isolated organs when compared to patients who received the placebo (inactive agent). The patients receiving BENLYSTA also were able to reduce their intake of steroid medications. The study is the largest ever to be c...

Lupus Research Institute Highly Encouraged by Benlysta(TM) Trial Results

...le-blind, placebo-controlled, multi-center trial, known as BLISS-52, both dose levels of Benlysta(TM) plus standard of care were more effective than a placebo plus standard of care in people with serologically active systemic lupus. A total of 867 participants at 90 clinical sites in 13 countries, primarily ...

Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Erythematosus

...verse event rates comparable between belimumab and placebo treatment groups. (Logo: http://www.ne...dard of care was superior in this study to that of placebo plus standard of care, while the safety profile wa... significantly reduced SLE disease activity versus placebo based on a number of other measures, including SEL...

Reliv International's GlucAffect(TM) Proven Effective in Clinical Study

...h their own baseline starting point and to the results of the people in the placebo group," said Dr. Carl Hastings, Reliv's vice chairman and chief scientific ... the metabolic syndrome. The participants consumed GlucAffect or a placebo product four times a day for six days a week, participated in an exercise p...

GNC Unveils Study Results for First and Only Nitric Oxide Product Clinically Proven to Improve Physical Performance at NSCA Conference in Las Vegas

... 1.5 gm (22.4%) and 3.0 gm (18.8%) supplement groups, but no change for the placebo group (-1.6%). The study followed 50 college-aged males over the course of four weeks who were randomized into one of three groups - a. placebo (microcrystalline cellulose), b. 1.5 gm of micronized arginine and 300 mg o...

Results From Trials of DHA in Alzheimer's Disease and Age-Related Cognitive Decline

...uble blind, randomized, placebo-controlled clinical trial comparing DHA and placebo in 402 people (average age=76) diagnosed with mild to moderate Alzheimer's ...y DHA intake of less than 200 mg per day. Subjects were treated with DHA or placebo at a dose of two grams per day for 18 months. Those participants already ta...

Iontophoretic Drug Delivery System (IDDS) Containing Lidocaine and Epinephrine is Effective in Reducing Pain Associated With Insertion of an Intravenous Catheter in a Phase 2 Clinical Trial

...ture procedure were 16.4 mm for the Active treatment versus 24.0 mm for the placebo treatment (p=0.0235). Therefore, the trial demonstrated statistically lower VAS scores for the Active group as compared to the placebo group. In addition, more than 80% of the Active group reported pain elimina...

Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial

..., ACR 50, ACR 70 and DAS28 response rates than the placebo group. The efficacy results for the two dosing gr... ACR 20 ACR 50 ACR 70 DAS28<2.6 placebo 153 53 (35%) 29 (19%) 16 (10%) 9 (... these were generally evenly distributed among the placebo and active dose groups. The mean increase in ...

BioCis Pharma Reports Positive Phase IIa Clinical Results in Atopic Dermatitis

... the 28-day period. Physician assessments, such as Eczema Area and Severity Index (EASI) were also evaluated. ProtoCure emulsion cream was superior to placebo in decreasing skin redness and improving skin barrier function. Statistically significant improvement was observed as early as day 10 after begining t...

Accumetrics, Inc. Announces GRAVITAS Trial 50 Percent Enrolled

...rate the value of providing clinicians with actionable information for patients who are poor responders to clopidogrel (Plavix(R)). The multi-center, placebo controlled trial will determine whether tailored antiplatelet therapy for poor responders, identified based on the results of the company's VerifyNow ...

Cephalon Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder

...ssment -- the Patient Global Impression of Severity (PGI-S). Patients taking NUVIGIL (150 mg/day) showed a statistically significant improvement over placebo as measured by the MSLT [p<0.0001] and the PGI-S [p<0.05]. The most common adverse events associated with NUVIGIL treatment (five percent or gr...

AcelRx Announces Positive Phase 2 Results from a Study of ARX-01 Sufentanil NanoTabs in Treating Post-Operative Pain

...eceive either 10 mcg or 15 mcg doses of ARX-01, or placebo for post-operative pain. Study drug was administer...ry endpoint, was also significantly different from placebo (p<0.001) for both treatment groups. ARX-01 was...profile of ARX-01 which was indistinguishable from placebo in both studies." About Acute Post-Operative...

Data Demonstrates Long-Term Reduction In Seizure Frequency With Novel Once Daily Anti-Epileptic Zebinix(R)

...onal firing. The efficacy of ESL has been demonstrated in three randomised, placebo controlled studies in 1049 patients with refractory partial onset seizures.... in the incidence of side effects between patients treated with ESL and the placebo group. Quality of life and depressive symptoms The effect of ...

Transave Receives $2.2 Million Cystic Fibrosis Foundation Award for Development of ARIKACE(TM)

... lung infections. A total of 46 patients have been randomized. ARIKACE or placebo are administered once daily for 28 days using an eFlow(R) Nebulizer System ...s were randomized 2:1 to two doses -- either 280 mg or 560 mg of ARIKACE or placebo for 28 days followed by a 28-day off-treatment observation period. Sixteen...

King Pharmaceuticals Showcases Data From Pain Pipeline of Medicines Designed to Deter Common Methods of Non-Therapeutic Use

...vere pain following bunionectomy surgery. The 405 participants received either two ACUROX(R) Tablets 7.5/30 mg, two ACUROX(R) Tablets 5/30 mg or two placebo tablets every six hours for 48 hours after surgery. Both doses of ACUROX(R) Tablets demonstrated significant reduction in pain compared to placebo. Th...

ThromboGenics' Microplasmin Phase III Program Progressing According to Schedule

... of the Phase III studies are multi-centre, randomized, placebo controlled, double-masked trials which will evaluate 125micro g of microplasmin versus placebo in the intravitreal treatment of patients with focal vitreomacular adhesion. The trials will enrol a total of approximately 320 patients each across a...

Jazz Pharmaceuticals and UCB Announce Second Phase III Study of Sodium Oxybate in Patients With Fibromyalgia Meets Primary Endpoints

... Patients' physical functioning and ability to perform daily tasks, as measured by the FIQ, were highly statistically significantly different from placebo for the 4.5 g/night dose and for the 6 g/night dose. Sodium oxybate-treated patients also reported highly statistically significant improvement in fat...

HEALTHPOINT-Sponsored Venous Leg Ulcer Clinical Trial Enrolls First Subject for Second Phase II Study

...signed to determine the effectiveness of two cell concentrations and two dosing frequencies of HP802-247 when combined with standard care, compared to placebo plus standard care, in healing venous leg ulcers over a 12-week treatment period. All trial patients undergo compression bandaging with a four-layer s...

Neurocrine Biosciences Presents Elagolix Data

...y n-telopeptide. Consistent pharmacokinetic profiles were maintained throughout the 42 days of treatment, and adverse events were comparable among the placebo and elagolix groups. The second clinical abstract at ENDO 09 reports results from a Phase II study where the safety of elagolix was evaluated in ...