Multicenter trial

Margolin A, Kosten TR, Avants SK, et al A multicenter trial of bupropion for cocaine dependence in methadone-maintained patients. Drug Alcohol Depend 40 125— 131, 1995... 

Efficacy. A pivotal study by Hurt et al. (1997) established the efficacy and safety of bupropion SRfor treatment of nicotine dependence, which led to its approval for this indication by the FDA in 1998. This study was a 7-week, double-blind, placebo-controUed, multicenter trial of three doses of bupropion SR (100 mg/day, 150 mg/day, or 300 mg/day in twice daily dosing). Patients were 6l5 cigarette smokers who smoked at least 15 cigarettes/day. The medication was administered in combination with weekly individual cessation counseling. End-of-trial 7-day point prevalence cessation rates were 19.0% for placebo and 28.8%, 38.6%, and 44.2% for the 100 mg/day, 150 mg/day, and 300 mg/day bupropion doses, respectively. At 1-year follow-up, cessation rates were 12.4% for placebo and 19.6%, 22.9%, and 23.1% for the 100 mg/day,... 

Lobeline. The alkaloid lobehne, whose mechanism of action in unclear but that appears to have dopamine reuptake blockade and nicotinic receptor antagonist properties (Dwoskin and Crooks 2002), was evaluated in a double-bhnd, randomized, placebo-controUed, multicenter trial involving 180 ciga-... 

Niaura R, Spring B, Borrelli B, et al Multicenter trial of fluoxetine as an adjunct to behavioral smoking cessation treatment. J Consult Clin Psychol 70 887-896, 2002... 

A recent randomized multicenter trial compared the efficacy of pegylated lFN-a2a monotherapy, adefovir monotherapy, and the pegylated lFN-a2a/adefovir combination administered for 48 weeks to patients with chronic hepatitis D. Adefovir did not inhibit HDV replication, and the combination had no additional benefit compared with pegylated IFN-a monotherapy in terms of the HDV RNA level (Yurdaydin et al. 2006). 

Pariser DM, Lowe NJ, Stewart DM, Jarratt MT, Lucky AW, Pariser RJ, Yamauchi PS (2003) Photodynamic therapy with topical methyl aminolevulinate for actinic keratosis results of a prospective randomized multicenter trial. J Am Acad Dermatol 48 227-232... 

Mertes PM, Moneret-Vautrin DA Skin reactions to intradermal neuromuscular blocking agent injections a randomized multicenter trial in healthy volunteers. Anesthesiology 2007 107 245. Moneret-Vautrin DA, Gueant JL, Kamel L, Laxenaire MC, el Kholty S, Nicolas JP Anaphylaxis to muscle relaxants cross-sensitivity studied by radioimmunoassays compared to intradermal tests in 34 cases. J Allergy Clin Immunol 1988 82 745. 

The MERCI trial was a prospective single-arm, multicenter trial designed to test the safety and efficacy of the MERCI clot retrieval device to restore the patency of intracranial arteries in the first 8 hours of an acute stroke. All patients were ineligible for IV rt-PA. The occlusion sites were the intracranial vertebral artery, basilar... 

The Penumbra stroke system (Penumbra Inc., San Leandro, CA) includes two different revascularization options (1) thrombus debulking and aspiration may be achieved by a reperfusion catheter that aspirates the clot while a separator device fragments it, and (2) direct thrombus extraction may be performed by a ring retriever while a balloon guide catheter is used to temporarily arrest flow. This system has been tested in a pilot trial in Europe. Twenty patients (mean NIHSS 21) with a total of 21 vessel occlusions (7 ICA, 5 MCA, and 9 Basilar) were treated up to 8 hours after symptom onset. Recanalization prior to lA lysis was achieved in all cases (48% TIMI 2 52% TIMI 3). Seven patients were also treated with lA UK or rt-PA. Good outcome at 30 days (defined as mRS < 2 or NIHSS 4-point improvement) was demonstrated in 42%. The mortality rate was 45%, but there were no device-related deaths. There was one asymptomatic SAH and three symptomatic ICHs. A prospective, single-arm, multicenter trial is being conducted in the United States and Europe currently. 

Dittrich R, Ritter M, Kaps M, Sieber M, Lees K, Lamie V, Nabavi D, Ringelstein E, Markus H, Droste D. The use of embolic signal detection in multicenter trials to evaluate antiplatelet efficacy signal analysis and quality control mechanisms in the CARESS trial. Stroke 2006 37 1065-1069. 

Cantarovich F, Rangoonwala B, Lorenz H, et al. High-dose furosemide for established ARF a prospective, randomized, double-blind, placebo-controlled, multicenter trial. Am J Kidney Dis 2004 44 402-409. 

Robertson JF, Osborne CK, Howell A, Jones SE, Mauriac L, Ellis M, Kleeberg UR, Come SE, Vergote I, Gertler S, et al. (2003) Fulvestrant versus anastrozole for the treatment of advanced breast carcinoma in postmenopausal women a prospective combined analysis of two multicenter trials. Cancer 98 229-238... 

Olsen, E.A., Kim, Y.H., Kuzel, T.M., Pacheco, T.R., Foss, F.M., Parker, S. et al. (2007) Phase IIB multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-ceU lymphoma. Journal of Clinical Oncology, 25, 3109-3115. 

Kristiansen K, Hagen S, Kollevold T, et al. Combined modality therapy of operated astrocytomas grade III and IV. Confirmation of the value of postoperative irradiation and lack of potentiation of bleomycin on survival time aprospective multicenter trial of the Scandinavian Glioblastoma Study Group. Cancer 1981 47 649-652. 

Cutlip DE, Chauhan MS, Bairn DS, et al. Clinical restenosis after coronary stenting perspectives from multicenter trials. J Am Coll Cardiol 2002 40 2082-2089. 

Page, J.G., Bernstein, J.E., Janicki, R.S., and Michelli, F.A. (1974) A multicenter trial of pemoline (cylert) in childhood hyperkinesis. In Conners, C.K., ed. Clinical Use of Stimulant Drugs in Children. The Hague, Netherlands Excerpta Medica, pp. 98-124. 

DeVeaugh-Geiss, J., Moroz, G., Biederman, J., Cantwell, D., Fontaine, R., Greist, J.H., Reichler, R., Katz, R., and Landau, P. (1992) Clomipramine hydrochloride in childhood and adolescent obsessive-compulsive disorder—a multicenter trial. / Am Acad Child Adolesc Psychiatry 31 45 9. 

High plasma levels of DVP (80-150 pg/mL 555-1,040 pmol/L) are expected to produce significantly more frequent tremors, thrombocytopenia, alopecia, asthenia, diarrhea, vomiting, and anorexia, compared to low serum levels (25-50 j,m/mL 175-345 pmol/L), as shown in a multicenter trial of DVP monotherapy in patients with poorly controlled partial epilepsy (Beydoun et al., 1997). 

A multicenter trial comparing more appropriate doses of imipramine (75 mg twice daily, N = 167) and St. John s wort extract (250 mg twice daily standardized to 0.2% hypericin, N = 157) showed no difference in efficacy after 6 weeks of treatment. However, St. John s wort seemed to reduce anxiety symptoms more often than imipramine and was better tolerated (Woelk, 2000). A study including 240 participants compared St. John s wort with fluoxetine in mild to moderate depression and also concluded that efficacy of both treatments was comparable (Schrader, 2000). These results have been replicated in a smaller trial us-... 

Riddle, M.R., Reeve, E.A., Yaryura-Tobias, J.A., et al. (2001) Fluvoxamine for children and adolescents with obsessive-compulsive disorder a randomized, controlled, multicenter trial./ Am Acad Child Adolesc Psychiatry 40 222-229. 

A review of 18 controlled studies in otherwise typically developing children (Moffatt et ah, 1993) demonstrated that only about 24% of children were completely dry while on medication and that 94% relapsed after medication was discontinued. In the Swedish Enuresis Trial (SWEET), 399 children aged 6-12 years with primary enuresis participated in an open, multicenter trial of DDAVP (Tullus et ah, 1999). Subjects were observed for 4 weeks and had their DDAVP dose titrated over 6 weeks (20 0 pg), followed by a 1-year long-term treatment period. A total of 245 children (61%) experienced a 50% or more reduction in the number of wet nights, with resolution of enuresis in 77 children. The greatest therapeutic effect was observed in children 6-7 years of age. There were no studies on the effectiveness of DDAVP in children with MR. 

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