Blind clinical trials phase

Conducting open-label studies can be a liberating and fascinating experience. When both the patient and the prescriber know the treatment being administered, many of the complexities of early-phase studies go away. Furthermore, when it is appreciated that double-blind clinical trials are always an abstraction from the ordinary clinical situation, to observe how one s new drug actually works in that latter environment is often eye-opening one common and pleasant experience is to see with one s own eyes how conservative was the estimate of product efficacy prior to its approval. 

Placebo-controlled trial A phase II, randomised, placebo-controlled, double-blind, clinical trial testing the efficacy of 12 months of GH treatment in 40 patients (53% male mean age = 62.7 years) with amyotrophic lateral sclerosis found that the incidence of adverse events did not differ significantly between placebo and treatment groups [42 ]. 

Acetyl-i-carnitine (4) is marketed in Italy for dementia as of this writing it is also in Phase III clinical trials in the United States and Europe. In a double-blind, placebo-controUed clinical trial over a one-year period involving 130 patients with clinically diagnosed AD, a slower rate of deterioration in 13 of the 14 outcome measures was observed in the dmg-treated group (28). Earfler smaller scale pilot studies in demented patients had also shown some improvement of various behavioral and cognitive functions (29). 

The clinical trial that resulted in FDA approval of bevacizumab (February 2004) was a randomized, double-blind, phase III study in which bevacizumab was administered in combination with bolus-IFL (irinotecan, 5FU, leucovorin) chemotherapy as first-line therapy for previously untreated metastatic colorectal cancer [3]. Median survival was increased from 15.6 months in the bolus-IFL + placebo arm to 20.3 months in the bolus-IFL + bevacizumab arm. 

Szeimies RM, Gerritsen MJ, Gupta G, Ortonne JP, Serresi S, Bichel J, Lee JH, Fox TL, Alomar A (2004) Imiquimod 5% cream for the treatment of actinic keratosis results from a phase III, randomized, double-blind, vehicle-controlled, clinical trial with histology. J Am Acad Dermatol 51 547-555... 

Jiang, R. H., Shu, L., Zhang, H. Y. et al. (2006). A phase II randomized double blind multi-centers and parallel control clinical trial for bupropion SR in the treatment of depressive disorders. Chinese Journal of New Drugs, 15(2), 128-31. 

Very recently, preliminary clinical investigations have commenced with WEB 2086. In a double-blind and placebo-controlled phase 1 clinical trial, the drug completely inhibited PAF-induced ex vivo platelet aggregation 45 min after single oral administration of 20-400 mg [305], The effect of single... 

A new malaria vaccine, RTS, S/AS02D, from GSK has shown very promising results in a Phase I/IIb double-blind randomized trial of 214 infants in Mozambique. For children in the -A year-old age group, the most vulnerable group, the vaccine not only lowered the chances of infection by 65% over 3 months but also reduced episodes of clinical malaria by 35% in 6 months. 

The United Kingdom Medicines Act 1968 regulations require that all medicinal products are properly labelled to certain minimum standards, but requirements vary from country to country. Clinical trial materials, however, cannot be labelled normally because if the trial is blind, nothing should reveal to the patient or physician the nature of the contents. The basic information on the label should provide the patient s name, study phase, study number, directions for use, any special warning or storage requirements, expiry date and the investigator s name and address, along with an indication that the... 

Becker MA, Schumacher HR, Wortmann RL, MacDonald PA, Palo WA, Eustace D et al. Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase a twenty-eight-day, multicenter, phase II, randomized, double-blind, placebo-controlled, dose-response clinical trial examining safety and efficacy in patients with gout. Arthritis Rheum 2005 52(3) 916-23. 

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]. 

Based upon these observations and following Phase I safety studies, a Phase II randomized, double-blind, controlled clinical trial was undertaken to treat active ulcerative colitis with escalating doses of ISIS 2302. Based on an intent-to-treat analysis, 59% (13/22) of patients treated daily with 240 mg ISIS 2302 enema over six weeks achieved a positive response, as measured by Disease Activity Index (DAI)... 

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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