Multicentre studies

Revicki DA, Palmer CS, Phillips SD, et al (1997). Acute medical costs of fluoxetine versus tricyclic antidepressants a prospective multicentre study of antidepressant drug overdoses. Pharmacoeconomics 11, 48—55. 

Youle M, Oslo M (2007) A double-blind, parallel-group, placebo-controUed, multicentre study of acetyl L-carnitine in the symptomatic treatment of antiretroviral toxic neuropathy in patients with HIV-1 infection. HIV Med 8(4) 241-250... 

Philipp, Michael, Ralf Kohnen and Karl O. Hiller, Hypericum Extract Versus Imipramine or Placebo in Patients with Moderate Depression Randomised Multicentre Study ofTreatment for Eight Weeks , British Medical Journal 319 (1999) 1534-39... 

Cucinotta D, De Leo D, Frattola L, Trabucchi M and Parnetti L (1996). Dihydroergokryptine vs. placebo in dementia of Alzheimer type Interim results of a randomized multicentre study after a 1 year follow up. Archives of Gerontology and Geriatrics, 22, 169-180. 

Pivotal pre-approval safety and efficacy was assessed in a randomized, open label, multicentre study of infertile females undergoing in vitro fertilization and embryo transfer. The primary efficacy parameter was the mean number of oocytes retrieved, which (at 13.6) was similar to the number retrieved when urinary-derived hCG was used. Serious potential side effects can include ovarian over/hyper-stimulation, sometimes with pulmonary or vascular complications. The product is marketed by Serono Inc. 

Bazedoxifene has also demonstrated in experimental studies its ability to inhibit the growth of ER(+) tumors in mice and rats in the absence of uterotrophic effects (Greenberger et al. 2001). At the present time bazedoxifene s ability to counteract the estrogenic effects of CEE at the levels of both breast and endometrium is being tested in a multicentric study comparing calcium + vitamin D to bazedoxifene with and without a low dose of CEE in mild symptomatic postmenopausal women. 

Multicentre studies have demonstrated the efficacy of rituximab, a chimeric IgG-1 directed against CD20, in the treatment of relapsed low-grade and follicular non-Hodgkin lymphoma. In 166 patients, receiving 375 mg rituximab in four weekly doses, the overall response rate was 50% in 161 evaluable patients who had previously received chemotherapy... 

In Europe generally, considerable variation in composition and in procedures occurs between lECs. Membership frequently depends on individuals who are willing to give their time without payment. Also, suitable members for this t)q)e of review board often have limited time. The new Clinical Trial Directive should provide the incentive for greater uniformity. A single lEC wiU give an opinion on a multicentre study within 60 days. 

Unless there are specific instructions in the protocol to the contrary, there should be a clearly documented trail of the drugs supplies that came in, what was administered to the subjects and what was returned by the subject in terms of unused medication. Any relaxation of drug accountability, as is seen sometimes in a multicentre study of many thousand subjects, can cause problems in monitoring the correct formulations and dosages given to the subjects. The significance of the... 

Jacobson SJ, Jones K, Johnson K, et al. Prospective multicentre study of pregnancy outcome after lithium exposure during the first trimester. Lancet 1992 339 530-3. 

Christopher LJ, Crooks], Davidson JF,ef a/. A multicentre study of Rauwolfia derivatives and breast cancer. Eur ] Clin Pharmacol 1977 11 409-17. 

SR090 Ziegler, H., and U. Holscher. Efficacy of saw palmetto fruit special extract WS 1473 in patients with alken stage I-II benign prostatic hyperplasia-open SRI01 multicentre study. Jatros Urol 1998 ... 

Clark C, Rosenblatt S A multicentre study of sertraline in the treatment of diabetic obesity. Paper presented at Progress in the Treatment of Simple and Compbcated Obesity, Osbon, 19 September, 1989... 

Danish University Antidepressant Group Paroxetine a selective serotonin reuptake inhibitor showing better tolerance but weaker antidepressant effect profile in comparison with clomipramine a controlled multicentre study. J Affect Disord 18 289-299, 1990... 

Eric L A prospective double-blind comparative multicentre study of paroxetine and placebo in preventing recurrent major depressive episodes. Biol Psychiatry 29 25-45, 1991... 

Gauthier S, Bouchard R, Lamontagne A, et al Tetrahydro-aminoacridine-lecithin combination treatment in patients with intermediate stage Alzheimer s disease results of a Canadian double-bhnd, cross-over, multicentre study. N Engl J Med... 

Stoll KD, Bisson HE, Eischer E, et al Carbamazepine versus halopeiidol in manic syndromes—first report of a multicentric study in Germany, in Biological Psychiatry... 

Wilcock G, Mobius HJ, Stoffler A, et al A double-blind, placebo-controlled multicentre study of memantine in mild to moderate vascular dementia (MMM500). Int Clin Psychopharmacol 17 297-305, 2002 Wilcock G, Howe 1, Coles H, et al A long-term comparison of galantamine and donepezil in the treatment of Alzheimer s disease. Drug Aging 20 777-789, 2003... 

De Wilde J, Spiers R, Mertens C, et al. A double-blind, comparative, multicentre study comparing paroxetine with fluoxetine in depressed patients. Acta Psychiatr Scand 1993 87 141-145. 

Arminen SL, Ikonen U, Puikkinen P, et al. A 12-week, double-blind, multicentre study of paroxetine and imipramine in hospitalized depressed patients. Acta Psychiatr Scand 1994 89 382-389. 

Philipp M, Kohnen R, Hiller K. Hypericum extract versus imipramine or placebo in patients with moderate depression randomised multicentre study of treatment for eight weeks. Br Med J 1999 319 1534—1538. 

Menne T, Wahlberg JE, Wilkinson JD. Corticosteroid contact allergy an EECDRG multicentre study. Contact 197. Dermatitis 1996 35(l) 40-4. 

Out HI, Mannaerts BM, Driessen SG, Coeling H, Bennink HI. A prospective, randomized, assessor-blind, multicentre study comparing recombinant and urinary follicle stimulating hormone (Puregon versus Metrodin) in in-vitro fertilization. Hum Reprod 1995 10(10) 2534-40. 

Sels JP, Verdonk HE, Wolffenbuttel BH. Effects of acarbose (Glucobay) in persons with type 1 diabetes a multicentre study. Diabetes Res Clin Pract 1998 41(2) 139-45. 

Riccardi G, Giacco R, Parillo M, Turco S, Rivellese AA, Ventura MR, Contadini S, Marra G, Monteduro M, Santeusanio F, Brunetti P, Librenti MC, Pontiroli AE, Vedani P, Pozza G, Bergamini L, Bianchi C. Efficacy and safety of acarbose in the treatment of Type 1 diabetes mellitus a placebo-controlled, double-blind, multicentre study. Diabet Med 1999 16(3) 228-32. 

Wagner VM, Grabert M, Holl RW. Severe hypoglcycemia, metabolic control and diabetes management in children with type 1 diabetes in the decade after the diabetes control and complications trial - a large scale multicentre study. Eur J Pediatr 2005 164 73-9. 

Hjalmas K, Hanson E, Hellstrom AL, Kruse S, Sillen U. Long-term treatment with desmopressin in children with primary monosymptomatic nocturnal enuresis an open multicentre study. Swedish Enuresis Trial (SWEET) Group. Br J Urol 1998 82(5) 704-9. 

Abramov Y, Elchalal U, Schenker JG. Febrile morbidity in severe and critical ovarian hyperstimulation syndrome a multicentre study. Hum Reprod 1998 13(11) 3128-31. 

McClelland, R. A., Wilson, D., Leake, R., Finlay, P., and Nicholson, R. I. 1991. A multicentre study into the reliability of steroid receptor immunocytochemical assay quantification. Eur. J. Cancer 27 711-715. 

Condon, P.I., et.al. 1999. Double blind, randomised, placebo controlled, crossover, multicentre study to determine the efficacy of a 0.1% (w/v) sodium hyaluronate solution (Fermavisc) in the treatment of dry eye syndrome. Br J Ophthalmol 83 1121. 

Green H, Hay P, Dunn DT, et al. A prospective multicentre study of discontinuing prophylaxis for opportunistic infections after effective antiretroviral therapy. HIV Med. 2004 5 278-283. 

Billiard M, Besset A, Montplaisir J, Laffont F, Goldenberg F, Weill JS, Lubin S. Modafinil a double-blind multicentric study. Sleep 1994 17 S107-S112. 

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