Clinical trials randomization, placebo-controlled

Kranzler HR, Wesson DR, Billot L Naltrexone depot for treatment of alcohol dependence a multicenter, randomized, placebo-controlled clinical trial. Alcohol Clin... 

AREDS Research Group (2001). A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, 3-carotene, and zinc for age-related macular degeneration and vision loss, AREDS Report No. 8. Arch. Ophthalmol. 119(10) 1417-1436. 

Clinical evaluation entailed administration to 45 MPS I patients in a randomized, placebo-controlled clinical trial. The primary efficacy outcomes assessed were forced vital capacity and distance walked in 6 min, both of which were statistically higher relative to placebo after 26 weeks of treatment. The most serious adverse reaction noted was that of a severe anaphylactic reaction in one patient. The most common adverse effects reported were respiratory tract infection, rash and injection-site reactions. The product is manufactured by BioMarin Inc. and is distributed by Genzyme Corporation. 

Liu J, Zhu H, Huang Q, Zhang Z, Li H, Qin Y, Zhang Y, Wei D, Lu J, Liu H, Xen X, Liu Y, Ekangaki A, Zheng Y, Diez-Perez A, Harper K (2004) Effects of raloxifene hydrochloride on bone mineral density, bone metabolism and serum lipids in Chinese postmenopausal women with osteoporosis a multi-center, randomized, placebo-controlled clinical trial. Chin Med J 117 1029-1035 (in English)... 

Shepherd, F.A. et al., A randomized placebo-controlled trial of erlotinib in patients with advanced non-small cell lung cancer (NSCLC) following failure of 1st line or 2nd line chemotherapy. A National Cancer Institute of Canada Clinical Trials Croup (NCIC CTC) trial, Proc. Am. Soc. Clin. Oncol., 22(SuppL), 14S, Abstr. 7022, 2004. 

Meltzer, E. O., Malmstrom, K., Lu, S., et al. (2000) Concomitant montelukast and loratadine as treatment for seasonal allergic rhinitis a randomized, placebo-controlled clinical trial. J. Allergy Clin. Immunol. 105, 917-922. 

In 1999, TA-CD was tested on human subjects. Volunteers were injected with the cocaine vaccine once a week for four weeks and, according to researchers, antibody responses lasted almost three months without any adverse affects. In October of 2003, Xenova began testing TA-CD in a randomized, placebo-controlled clinical trial involving 132 human subjects. They expect to complete this study in 2005 and move into Phase III studies. ... 

A number of studies have been performed on the efficacy of St. John s Wort as an antidepressant. Several meta-analyses of these studies have also been published. The first such metaanalysis involved 23 randomized trials (15 placebo-controlled and eight active-controlled) involving 1,757 outpatients. It concluded that there was preliminary evidence supporting hypericum extracts as being superior to placebo in patients with mild to moderate clinical depression ( 233). Two more recent reviews of subsequent, placebo-controlled studies also concluded that hypericum is more effective than placebo but possibly less effective than TCAs ( 234, 235). At least two large-scale, multicenter, double-blind, placebo- and active-controlled studies are ongoing in the United States, testing the efficacy of hypericum versus an SSRI in patients with major depression. The results of these studies should further clarify the role of hypericum in the treatment of depressive disorders. 

It should be noted that these clinical trials are typically conducted within a short time period and thus may not reflect long-term outcomes. The utility of St. John s wort in the treatment of moderate to severe depression has been investigated (14-17) in large randomized placebo-controlled multi-institutional studies. Some such studies demonstrated efficacy (16), but others failed to detect a clinically significant effect on the symptoms of the moderate to severely depressed individuals (15,17). Gelenberg et al. demonstrated a relapse rate of approximately 30% in moderate to severely depressed individuals who initially responded to St. John s wort therapy as would be expected from experience with prescription antidepressants (14). 

The drug is currently undergoing clinical trials, and the initial results from a double blind, randomized, placebo-controlled trial using this compound have been positive both for early treatment and prophylaxis of experimental inoculation of human volunteers [98] with influenza A/Texas/91. 

In October 2005, Osiris received approval from the US Food and Drug Administration (FDA) to conduct a non-randomized, open-label, phase II clinical trial in adult and pediatric patients with treatment-refractory severe GVHD [628422]. By November 2005 the trial had begun, enrolling 30 patients and setting a planned completion date of January 2007. At the same time, a second phase II, double-blind, randomized, placebo-controlled clinical trial, expected to enroll 75 patients to assess the safety and efficacy of OTI-010 in acute gastrointestinal GVHD, was initiated by Osiris, with an expected completion date of April 2008 [www.clinicaltrials.gov], [632720]. 

Prednisone, 10 mg/day for 1 year, has been evaluated in 136 patients with probable Alzheimer s disease in a double-blind, randomized, placebo-controlled trial (93). There were no differences in the primary measures of efficacy (cognitive subscale of the Alzheimer Disease Assessment Scale), but those treated with prednisone had significantly greater memory impairment (Clinical... 

Saw J. Lack of adverse clopidogrel-atorvastatin clinical interaction from secondary analysis of a randomized, placebo-controlled clopidogrel trial. Circulation 2003 108 921 1. 

Wagner, J. A. et al. (2002). A phase II, double-blind, randomized, placebo-controlled clinical trial of tgAAVCF using maxillary sinus delivery in... 

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