Placebo in Medical Technology

Labopharm files New Drug Submission with Health Canada for novel antidepressant

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

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 ... 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 ...

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

... bleeding was not statistically different from placebo and the rate of endometrial hyperplasia in doses ... significantly different from those reported with placebo over two years of study. 2. ... 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

... three arms, BCI-952 (n=67), buspirone (n=34) or placebo (n=33). Co-primary endpoints were the Clinical ... 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 ...

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 ... range in this patient population, the reported placebo response rates were considerably higher than seen ... the reported response rates between R788 and placebo were significantly different) and month 3 (when ...

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

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

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 ... 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 ...

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

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

Data Suggest Sodium Oxybate Significantly Improves Pain and the Core Symptoms of Fibromyalgia

... VAS score, compared with 35.2% of patients taking placebo using Last Observation Carried Forward analysis. ... as early as Week 1 after dosing compared with placebo as measured by the Fatigue VAS (p<0.001). ... improvement in sleep patterns compared to placebo as measured by the Jenkins Sleep Scale ...

New Analysis Shows Efficacy of SIMPONI(TM) (golimumab) in Anti-TNF Experienced Rheumatoid Arthritis Patients

... compared with 18 percent of patients receiving placebo ( p <0.001). Thirty-four percent of patients ... compared with 20 percent of patients receiving placebo ( p =0.027). "Golimumab has shown promise ... responders at week 14 in the combined SIMPONI vs. placebo groups. A subset of patients receiving a single ...

Two-Year Data Show Patients Receiving SIMPONI(TM) (golimumab) Experienced Sustained Improvement in Signs and Symptoms of Psoriatic Arthritis and Ankylosing Spondylitis

... patients with active PsA were randomized to placebo (n=113), SIMPONI 50 mg (n=146) or SIMPONI 100 mg ... SIMPONI 50 mg after switch from placebo at week 16 (24 of 31 patients) SIMPONI 50 mg after switch from placebo at week 24 (28 of 31 patients) SIMPONI 50 ...

Data Demonstrated ACTEMRA(R) (tocilizumab) Significantly Inhibited Progression of Structural Joint Damage in Rheumatoid Arthritis Patients

... compared with 8 percent of patients treated with placebo plus methotrexate. "Inhibiting RA from ... with patients treated with methotrexate plus placebo (0.29, 0.34 versus 1.1, respectively; ... mg/kg or 8 mg/kg) plus methotrexate compared with placebo plus methotrexate in RA patients for the ...

Merz Pharmaceuticals Announce Three Studies of NT-201 - (Botulinum neurotoxin type A Free From Complexing Proteins)

... PARIS, June 9 /PRNewswire/ -- Results from three placebo controlled studies conducted to assess NT-201 in ... 83.3 months), Patients were randomized to placebo (N= 46), 120 U NT 201 (N= 47), and 240U NT 201 ... group) . AEs occurred in 34.8% of patients of the placebo group, 55.3% of the 120 U group and 46.0% of the ...

DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD

... group compared to 16 patient (24%) deaths in the placebo group (p-value 0.0139). At one year post ... the orBec(R) group and 28 patients (42%) in the placebo group died within one year of randomization (46% ... 31 (71%) vs. 12 of 29 (41%) in the orBec(R) and placebo groups, respectively (p-value 0.02). ...

Merz Pharmaceuticals Announces Results of Clinical Trials with NT-201(Botulinum neurotoxin type A free from complexing proteins) at Annual Movement Disorders Society Meeting

... spasticity trial (73 NT 201 patients and 75 placebo patients). For the safety analyses, 6 clinical ... been included (n=539 NT 201, n=442 BTXCo and n=75 placebo subjects). For the post-launch evaluation ... the efficacy as good or very good compared to placebo (33%). 26.7% of patients in the NT 201 group, ...

Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk

... in highly significant improvements as compared to placebo in multiple secondary endpoints associated with ... of their weight compared to 32.1% of patients on placebo (p<0.0001), and over one-third (36.2%) of ... least 10% of their weight compared to 13.6% for placebo (p<0.0001). The average weight loss in this ...

Study Demonstrating Lurasidone Is Effective in Patients With Schizophrenia Published in The Journal of Clinical Psychiatry

... statistically significant improvement versus placebo in both primary and secondary efficacy ... improvement at Week 6 (LOCF endpoint) compared to placebo on the BPRSd (-8.9 vs. -4.2; p=0.012), as well as ... differences were observed between lurasidone and placebo for EPS (assessed using the Simpson-Angus Scale) ...

PROTECT-1 Phase II/III Induction-Stage Results for ChemoCentryx's Traficet-EN(TM) Presented in Oral Session at DDW 2009 Conference

... Crohn's disease was consistently superior to placebo across multiple efficacy endpoints. At week 12, ... in the 500 mg QD group versus 47 percent for placebo (p=0.039). Similarly, the CDAI greater than or ... 55 percent in this group versus 40 percent for placebo (p=0.029). In his oral presentation, Dr. Keshav ...

Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinical Program

... Reductions in Steroid Usage Compared to placebo New Preclinical Studies Indicate ... did not reach statistical significance (p=0.1). placebo patients tolerated a 50 percent reduction in ... significant (p=0.001) improvement compared to placebo over the twelve weeks of study duration in ...

Keryx Biopharmaceuticals Announces Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer

... as Extends Overall Survival vs. Capecitabine + placebo in Patients with 2nd or 3rd Line Metastatic Colon ... 1-14 every 21 days, plus either perifosine or placebo at 50 mg daily. Treatment was continued until ... arm and 15 patients on the capecitabine + placebo arm). The three patients not evaluable for ...

Results and Additional Analyses From Study Show That Corthera's Relaxin for Acute Heart Failure is the Strongest Predictor of Improved Longer-Term Outcomes Following Hospital Discharge When Compared to Other Variables

... at doses of 10, 30, 100, or 250 mcg/kg/day or placebo for two days. The study indicated that the ... as compared to 23% of patients assigned to placebo (p=0.04). Relief remained significantly greater ... cardiovascular causes, as compared to 17% in the placebo group (p=0.06), a greater than 80% reduction. ...

Ironwood and Forest Present Additional Positive Phase 2b Study Results for Linaclotide in Patients With Irritable Bowel Syndrome With Constipation

... of treatment, compared with 25 to 37 percent of placebo patients (p<0.05 for each pairwise comparison of a linaclotide dose group to the placebo group). For patients receiving the Phase 3 ... effects of 75, 150, 300, or 600 ug linaclotide or placebo administered orally once daily to adults meeting ...

Keryx Biopharmaceuticals Reports Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer

... as Extended Overall Survival vs. Capecitabine + placebo in Patients with 2nd or 3rd Line Metastatic Colon ... 1 - 14 every 21 days, plus either perifosine or placebo at 50 mg daily. Treatment was continued until ... arm and 15 patients on the capecitabine + placebo arm). The three patients not evaluable for ...

Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types

... was 27.14 months versus 7.21 months for those on placebo (P=0.0008)(1). Further, a statistically ... Sandostatin LAR versus 7.2 months in the placebo group (P<0.0001)(1). The trial, called ... with either Sandostatin LAR (30 mg/month) or placebo for 18 months, or until tumor progression or ...

Video: UCB Launches Vimpat(R) in the U.S. for Add-On Treatment of Epilepsy in Adults

... respectively, versus only 18.4% reduction in the placebo group. Additionally, 34.1% and 39.7% of patients ... in seizure frequency versus only 22.6% in the placebo group. Patients randomized to Vimpat(R) also ... the 12-week maintenance phase, vs. 0.9% of placebo patients. Seizure free days increased by 8% with ...

Two-Year Data Reinforce Effect of ACTEMRA(R) (tocilizumab) in Inhibiting Progression of Joint Damage and Improving Physical Function in Rheumatoid Arthritis Patients

... of treatment compared with patients receiving placebo plus methotrexate. The outcome was determined by ... and 4 mg/kg) plus methotrexate compared with placebo plus methotrexate in RA patients. Patients in the ... every four weeks plus methotrexate weekly or placebo infusions every four weeks plus methotrexate ...

Dainippon Sumitomo Pharma Announces Lurasidone Phase III Data in Patients With Schizophrenia

... 80 mg/day was significantly more effective than placebo for the treatment of acute schizophrenia. In ... 80 mg/day was significantly more effective than placebo at the study endpoint, lurasidone was associated ... mg/day, which did not demonstrate separation from placebo on the PANSS or CGI-S at study endpoint. ...

Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)

... 72 was -6.5% and -9.6% in the pirfenidone and placebo groups, respectively, in CAPACITY 2, and -6.5% ... at week 72 in the pirfenidone group than in the placebo group. This magnitude of decline is considered ... effect of 1197 mg was intermediate as compared to placebo and 2403 mg pirfenidone, indicative of a ...

RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder

... delayed the time to relapse compared to placebo in patients with Bipolar I Disorder. Results of ... therapy with RISPERDAL(R) CONSTA(R) (N=154) or placebo (N=149). The median duration of treatment was ... group and five months for patients in the placebo group. The primary endpoint was time to relapse ...

Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures 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< .001). The ... of the NYPRS-S in the INTUNIV group compared to placebo (-16.0 vs -9.6; P< .001). In this ...

Medarex Announces Primary Endpoint Achieved in MDX-1100 Anti-IP-10 Antibody Phase 2 Trial for Rheumatoid Arthritis

... significant improvement in ACR20 responses over placebo PRINCETON, N.J., May 14 ... were statistically significant when compared with placebo (p=0.0024). The antibody combination with ... in the study were randomized to receive either placebo or MDX-1100 (10 mg/kg) every two weeks for a ...

Ongoing Landmark ROADMAP Study Demonstrates Significant Improvement in Blood Pressure Control at One Year, According to Blinded Results

... patients randomized either to olmesartan or placebo in addition to standard antihypertensive ... to receive 40 mg of olmesartan medoxomil or placebo for an average of five years. Patients with ... with either olmesartan medoxomil therapy or placebo after one year, mean systolic BP reduction was ...

New Data Shows Blood Pressure Reduction Therapy with BENICAR(R) and BENICAR HCT(R) Effectively Reduces Blood Pressure in Elderly Patients to Target Blood Pressure

... (Stage 2) hypertension. Following a 2-3 week placebo period, 176 patients started olmesartan (OM) 20 ... AEs with BENICAR and BENICAR HCT was similar to placebo -- The only AE that occurred ... treated with BENICAR(R) and more frequently than placebo was dizziness (3% vs 1%) -- AEs reported in ...

New Data Shows AZOR(R) (amlodipine and olmesartan medoxomil) Significantly Improves 24-Hour Ambulatory Blood Pressure

... Design AZTEC was a 15-16-week (3- to 4-week placebo run-in and 12-week active treatment periods), ... and achievement of BP goals. Following placebo run-in, patients were started on amlodipine (AML) ... treated with AZOR and more frequently than placebo was edema. The placebo-subtracted incidence was ....

RAPAFLO(TM) (silodosin) Provides Rapid and Sustained Benign Prostatic Hyperplasia (BPH) Symptom Relief in as Little as Three Days

... statistically significant symptom relief versus placebo within three to four days of starting treatment, ... to either 8 mg RAPAFLO (TM) (n=466) or placebo (n=457) taken once daily with breakfast for 12 ... patients treated with RAPAFLO (TM) versus placebo experienced significantly greater changes in ...

ISTA Pharmaceuticals Highlights Bepreve(TM) Clinical Data at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting

... for improvement in ocular itching compared to placebo for up to 16 hours after dosing. In addition, ... studies enrolled a total of 157 patients in the placebo and Bepreve 1.5% treatment groups. The study ... hours after dosing and statistically superior to placebo in reducing ocular itching at CAC tests conducted ...

Arcion Therapeutics' Topical Pain Candidate, ARC-4558, Significantly Reduces Pain Caused by Diabetic Neuropathy

... greater reductions in pain when compared to placebo (p=0.015). This improvement was demonstrated in ... the 0.2% group did not differ from those in the placebo group, though a trend was observed (p=0.054). The ... 30% or more pain relief compared to 29.3% in the placebo group (p=0.031). Blood levels of clonidine ...

Results From Phase 3 EQUATE Trial of VIVUS' Qnexa Highlighted at European Congress on Obesity

... with two doses of Qnexa versus that achieved with placebo among 756 patients over 28 weeks. Patients taking ... as compared to 1.7 percent reported for the placebo group. All results were evaluated using ITT-LOCF, ... events reported for the full-dose, mid-dose and placebo group were tingling (23%, 16%, 3%), dry mouth ...

FDA Approves Vanda Pharmaceuticals' Fanapt(TM) for the Treatment of Schizophrenia

... III clinical studies comparing Fanapt(TM) to placebo and active control in patients with ... and Fanapt(TM) was shown to be superior to placebo in controlling symptoms of schizophrenia across ... fixed dose of Fanapt(TM) (24 mg/day) compared to placebo and an active control (Geodon(R)), the 24 mg/day ...

Study Reported Tadalafil Taken Once Daily Improved Erectile Function in Men with ED and Sexual Quality of Life in Couples

... study, men were randomized to receive either a placebo (N=78) or tadalafil 5 mg (N=264) taken once daily ... tadalafil group, compared with 0.7 points in the placebo group. Men in the tadalafil group reported a ... on average (compared with 2.7 percent in the placebo group) in the ability to achieve an erection ...