Placebo in Medical News

Surgery, 'Sham' Equal in Treating Compression Fracture Pain

... Injecting cement into spine no better than placebo procedure, study finds WEDNESDAY, ... a "sham" surgery without cement. Those in the placebo arm went through the motions of surgery, ... of the cement," Kallmes said. It could be the placebo effect or something as simple as the effect of ...

Boehringer Ingelheim to Commence Phase III Study Investigating the Role of BIBW 2992 as First-Line Treatment for Non-Small Cell Lung Cancer (NSCLC) Patients with EGFR Mutations

... 2008;27:4702-4711. (2) BIBW 2992 and BSC Versus placebo and BSC in Non-Small Cell Lung Cancer Patients ... 1: BIBF 1120 Plus Docetaxel as Compared to placebo Plus Docetaxel in 2nd Line NSCLC. Available at: ... Lung 2: BIBF 1120 Plus Pemetrexed Compared to placebo Plus Pemetrexed in 2nd Line Nonsquamous NSCLC. ...

Advanced targeted therapies effective as first-line treatment for lung cancer

... progression-free survival (PFS) over those on placebo a 29 to 31 percent reduction in risk of ... them with either 150mg/day of erlotinib or placebo after four cycles of platinum-based doublet ... 3. EFFICIENCY OF MAINTENANCE ERLOTINIB VERSUS placebo IN PATIENTS WITH UNRESECTABLE STAGE III NON-SMALL ...

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

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

FDA Approves TYVASO (Treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial Hypertension

... in six-minute walk distance over those taking placebo (p<0.0005). The safety and effectiveness in ... side effects (>= 10%) seen with TYVASO in the placebo controlled clinical study were cough, headache, ... side effects (>= 10%) seen with TYVASO in the placebo controlled clinical study were cough, headache, ...

NHLBI stops study of pulmonary hypertension treatment in sickle cell patients

... found that, compared to participants on placebo (dummy pill), participants taking sildenafil ... were randomly assigned to receive sildenafil or placebo for 16 weeks. Participants could also receive ... -- compared to 8 percent of participants in the placebo group. "Although these preliminary results ...

Quigley Corporation Announces Final Results of Quigley Pharma's Phase IIb Study

... no statistical differences, between active and placebo groups for the primary and secondary endpoints ... was a double-blind, randomized, parallel-group, placebo controlled study conducted at 22 sites with 1 to ... to the feet three times daily (tid) with placebo or QR-333 for 12 weeks. Number of ...

Nexavar in Combination with Chemotherapy Shown to Extend Progression-Free Survival in Patients with Advanced Breast Cancer

... to receive 400 mg of oral Nexavar or matching placebo twice daily, in addition to 1000 mg/m(2) of ... of causality was 15% for Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac ... respectively, were 45% for Nexavar vs. 32% for placebo and 38% for Nexavar and 28% for placebo. Women of ...

96-Week Safety and Efficacy Findings Presented for INTELENCE(TM) (etravirine) As Part of HIV Combination Therapy

... plus background regimen (BR) compared with placebo plus BR. These findings were presented today at ... compared to 36 percent of patients in the placebo arm (p<0.0001). "These data are ... INTELENCE 200 mg twice daily (599 patients) or placebo (604 patients), each given in addition to a BR. ...

-Contrave(R) Obesity Research Phase 3 Program Meets Co-Primary and Key Secondary Endpoints; Exceeds FDA Efficacy Benchmark for Obesity Treatments-

... after 56 weeks, approximately three times the placebo categorical response rates of 16.4% and 17.1%, ... weeks, more than double the 18.9% of patients on placebo (p<0.001). Contrave patients also showed a ... Patients were randomized to receive either placebo or Contrave, BID, with a four week titration ...

Study Evaluating Efficacy and Safety of Two Low-dose Regimens of PREMARIN Vaginal Cream for the Treatment of Moderate to Severe Vaginal Atrophy Now Published

... (equivalent to a low-dose of CE cream 0.3 mg) or placebo once daily (21 days on/7 days off) or twice ... 0.5 g were significantly greater relative to placebo ( P <0.001). Results from the 12-week phase ... the most bothersome symptoms score versus placebo at 12 weeks ( P less than or equal to 0.001), ...

Drug Limits Stomach Trouble in Patients Taking Low-Dose Aspirin

... to take either 20 milligrams of famotidine or a placebo twice a day. After 12 weeks, all the participants ... of the famotidine group and in 17 percent of the placebo group. Gullet ulcers were found in 4 percent of the famotidine group and in 19 percent of the placebo group. "Famotidine is effective in the ...

VYVANSE CII provided significant efficacy at 14 hours in adults with ADHD

... of VYVANSE, 30 mg, 50 mg, and 70 mg, compared to placebo in 142 adults with ADHD using the adult simulated ... the duration of efficacy of VYVANSE compared to placebo using PERMP; the PERMP total score is the sum of ... for the VYVANSE group compared to 289.5 for the placebo group; P In addition to PERMP, the ...

Antibiotics May Boost Risk for Recurrent Ear Infection

... compared with 43 percent of children given a placebo at the time of their initial infection. The ... infection, compared with 37 of 86 children in the placebo group. That equated to a 2.5 times higher risk of ... also found that 30 percent of children in the placebo group had ear, nose and throat surgery after ...

Drug Found Ineffective Against Lung Disease

... 200 micrograms of Ifn-g1b (551 people) or a placebo (275) three times a week. After a median of 64 ... those in the Ifn-g1b group and 13 percent in the placebo group had died. Symptoms such as flu-like ... among those in the Ifn-g1b group than in the placebo group. The two groups had similar rates of ...

New Data: Efficacy and Responder Analyses of Divigel(R) (estradiol gel) 0.1 percent for the Treatment of Menopause

... of women in all treatment groups versus placebo experienced > / = 50 percent reduction in the ... this 12-week efficacy and safety study, comparing placebo to the low-dose transdermal Divigel(R) at doses ... significant improvements compared with placebo as early as week two that were maintained ...

Favorable Vote From FDA Advisory Committee on SEROQUEL Pediatric Supplemental New Drug Applications

... risk (1.6 to 1.7 times) of death, compared to placebo (4.5% vs. 2.6%, respectively). SEROQUEL is not ... exposure 213 days) vs.4.6% in patients receiving placebo (mean exposure 152 days). Clinically ... reactions associated with the use of SEROQUEL vs. placebo in clinical trials for schizophrenia and bipolar ...

NUVIGIL Jet Lag Disorder Data Presented at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies

... compared to 4.8 minutes for subjects taking placebo and 7.7 minutes for subjects taking NUVIGIL ... averaged across days one and two, compared with placebo (1.6 armodafinil 150mg/day versus 1.9 placebo; ... more frequently with NUVIGIL use compared to placebo (greater than or equal to five percent), included ...

Preliminary report on antidepressants published

... no proof of superiority. Only when compared to placebo was there proof that in acute treatment more ... no better in the mirtazapine group than in the placebo group. In addition, it was shown that patients ... (adverse events) than patients treated with placebo or with some of the other antidepressants. ...

Botox injections can significantly improve quality of life for people with overactive bladders

... London carried out a randomised, double-blind placebo trial on 34 patients with an average age of 50. ... ten women received the placebo. "The Botox or placebo injections were administered using a flexible ... dome of the bladder. In all, 200ml of Botox or placebo was administered." Patients in both groups ...

Roche to Commence Phase III Trials with Innovative Treatment Designed to Lower Cardiovascular Risk in Diabetes Patients with Recent Heart Attack

... Patients underwent a single-blind 4- to 5-week placebo run-in period, then were randomized to receive 16 ... daily doses (50, 150, 300 or 600 micrograms), placebo or 45 mg pioglitazone. The primary endpoint ... reductions from baseline HbA1c versus placebo was met and a range of responses observed from ....

VIVUS' Qnexa Shows Significantly Improved Blood Sugar Control Through Weight Loss In Patients With Type 2 Diabetes

... as compared to 1.1% (from 8.5% to 7.4%) in the placebo group (p<0.05), despite the addition of diabetes medications required in the placebo group during the course of the study; ... to a decrease from 171 mg/dL to 145 mg/dL for the placebo group (p=0.02). Additionally, patients had ...

Sangamo BioSciences Presents Positive Phase 2 ZFP Therapeutic Data at ADA 2009

... no difference was seen at 180 days between placebo and SB-509-treated subjects in Sangamo's ... A-NIS-LL in SB-509-treated subjects compared to placebo at Day 180 were seen for subjects entering the ... points compared to 0.2 point worsening for the placebo group (a delta in A-NIS-LL of 1.3 points, p ...

Cervical Cancer Vaccine Not Just for Teens

... which protects against the four HPV types, or a placebo at day one and months two and six of the study. ... the vaccinated group, compared to 41 cases in the placebo group. That means the vaccine was 91 percent ... four cases in the vaccine group and 23 in the placebo group, which means the vaccine was 83 percent ...

AstraZeneca Studies Show Relief of Nighttime Heartburn and Reduction in GERD-Related Sleep Disturbances

... sleep disturbances compared with patients taking placebo over four weeks(1). NEXIUM 20 mg is indicated for ... NEXIUM 20 mg once daily (n=137) compared with placebo (n=125) after four weeks (34.3% vs. 10.4%, P < ... with NEXIUM 20 mg once daily compared with placebo (71.5% vs. 55.2%, P=.006)(1). In a second ...

FDA Approves Reclast(R) to Prevent Osteoporosis in Postmenopausal Women With Convenient Less Frequent Dosing

... year, Reclast at the beginning of the study and placebo at one year, or placebo at the beginning of the study and again at one ... increased lumbar spine BMD relative to placebo at the end of the two-year study (1). Treatment ...

Drug Trials Show Modest Gains Against Lung Cancer

... randomly chosen to receive either pemetrexed or a placebo along with "best supportive care." The ... for a median of 13.4 months while those on the placebo survived 10.6 months, the research team reported. ... months in the Zactima arm versus 10 months in the placebo group," said Herbst, who led the trial. ...

MAP Pharmaceuticals Phase 3 Trial of LEVADEX(TM) Migraine Product Candidate Meets All Four Primary Endpoints

... improvement at two hours compared to patients on placebo for each of the primary endpoints: ... received LEVADEX compared with 34.5 percent for placebo (p<0.0001); Phonophobia free: 52.9 ... received LEVADEX compared with 33.8 percent for placebo (p<0.0001); Photophobia free: 46.6 ...

FDA Approves SAMSCA(TM) (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia

... who had previously been treated with either placebo or SAMSCA (and who had returned to standard of ... in patients receiving SAMSCA (n equals 223, placebo n equals 220) were thirst (16 percent vs. 5 percent in placebo patients), dry mouth (13 percent vs. 4 percent), ...

Results of phase III study on Labopharm's novel antidepressant published in Psychiatry (Edgemont) Journal

... of Labopharm's novel trazodone formulation to placebo in patients with major unipolar depressive ... demonstrated significant improvements versus placebo in all three quality of sleep end points, with an ... greater number of HAMD-17 responders than placebo by the end of titration. Adverse events of ...

New Data Demonstrate RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment May Improve Health Outcomes and Reduce Hospitalizations in Patients with Schizophrenia

... they did not compare RISPERDAL(R) CONSTA(R) to placebo or other treatments. The studies were ... 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, ... gain (>7% of baseline body weight) was 6% placebo versus 9% RISPERDAL(R) CONSTA(R). ...

Shire's INTUNIV (Guanfacine) extended release in children with ADHD and oppositional symptoms

... at a major psychiatric meeting. This randomized placebo controlled trial met its primary objective, which ... much improved" or "much improved" compared with placebo (71.5 percent vs 32.0 percent; P Significantly ... of the NYPRS-S in the INTUNIV group compared to placebo (-16.0 vs -9.6; P "These data are testament to ...

Mayo Clinic Researchers Say Agent Provides Treatment Option for Women with Hot Flashes

... and frequency about 20 percent more than did a placebo agent. Thus, pregabalin appears to offer about ... to test the use of antidepressants, compared to placebo treatment, for hot flashes. Gabapentin, an ... trial, testing three different treatment arms: a placebo versus daily doses of 150 milligrams (mg) of ...

FDA Grants Approval for Use of RISPERDAL(R) CONSTA(R) as Both a Monotherapy and Adjunctive Therapy in the Maintenance Treatment of Bipolar I Disorder

... as a monotherapy, was significantly better than placebo at delaying the time to relapse of any mood ... 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, ... gain (>7% of baseline body weight) was 6% placebo versus 9% RISPERDAL(R) CONSTA(R). ...

Here to Help(TM): Unique Program Combines Direct Personal Assistance With Web-Based Resources to Improve Opioid Dependence Treatment Outcomes

... events with SUBOXONE(R) include : headache (36%, placebo 22%), withdrawal syndrome (25%, placebo 37%), pain (22%, placebo 19%), insomnia ...

Two Studies at AACE 2009 Annual Meeting Highlight Effects of Welchol(R) (colesevelam HCl) on Blood Glucose and LDL-C in Patients with Type 2 Diabetes

... prior to randomized treatment, the Welchol and placebo groups had comparable A1C levels (8.2 and 8.1 ... but naive to Welchol (i.e., those treated with placebo during the 26-week randomized phase), who were ... of patients - and more commonly with Welchol than placebo - regardless of investigator assessment of ...

Mayo Clinic researchers say agent provides treatment option for women with hot flashes

... and frequency about 20 percent more than did a placebo agent. Thus, pregabalin appears to offer about ... to test the use of antidepressants, compared to placebo treatment, for hot flashes. Gabapentin, an ... trial, testing three different treatment arms: a placebo versus daily doses of 150 milligrams (mg) of ...

Combo Treatment Eases Wheezing in Babies

... placebo; the third group received a nebulized placebo and the oral dexamethasone; and the final group was given a nebulized and oral placebo treatment. After seven days, 17.1 percent of ... group were hospitalized, and 26.4 percent in the placebo group were admitted to the hospital. The ...

AZOR(R) Receives FDA Approval as First-Line Treatment for High Blood Pressure

... treated with AZOR(R) and more frequently than placebo was edema. The placebo-subtracted incidence was ... and 11.2% (10/40 mg). The edema incidence for placebo was 12.3%. Adverse reactions seen at lower ... or greater incidence as in patients receiving placebo included hypotension, orthostatic hypotension, ...

Herpes medication does not reduce risk of HIV transmission

... 41 infections in the acyclovir arm and 43 in the placebo arm not a significant difference. Acyclovir ... a reduction of 40%), compared to the placebo arm. "The Partners in Prevention Study is a ... the number of participants in the acyclovir and placebo arms whose CD4 T-cell counts declined to below ...